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January 1, 2019Comments OffHeadache Drug Trial | Headache Relief | Headache Shampoo | Headache Study | Headache Therapy
Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors
Experimental: Single Agent Escalation

INBRX-105 will be escalated in patients with locally advanced or metastatic solid tumors.

Drug: INBRX-105 – PDL1x41BB antibody

The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Experimental: Expansion Cohort Non-small Cell Lung Cancer

Patients will be treated with single-agent INBRX-105 at either the MTD or RP2D.

Drug: INBRX-105 – PDL1x41BB antibody

The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Experimental: Expansion Cohort Melanoma

Patients will be treated with single-agent INBRX-105 at either the MTD or RP2D.

Drug: INBRX-105 – PDL1x41BB antibody

The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Experimental: Expansion Cohort PD-L1 Positive Basket

Patients with gastric or gastro-esophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma will be treated with single-agent INBRX-105 at either the MTD or RP2D.

Drug: INBRX-105 – PDL1x41BB antibody

The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Experimental: Expansion Cohort Head and Neck Squamous Cell Carcinoma

Patients with head and neck squamous cell carcinoma will be treated with single-agent INBRX-105 at either the MTD or RP2D.

Drug: INBRX-105 – PDL1x41BB antibody

The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Experimental: INBRX-105 Escalation in Combination with Pembrolizumab

INBRX-105 will be escalated in combination with Pembrolizumab in pateitns with locally advanced or metastatic solid tumors.

Drug: INBRX-105 – PDL1x41BB antibody

The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Drug: Pembrolizumab

Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.

Other Name: Keytruda

Experimental: Combination Expansion Cohort Non-small Cell Lung Cancer

Patients will be treated with INBRX-105 in combination with Pembrolizumab.

Drug: INBRX-105 – PDL1x41BB antibody

The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Drug: Pembrolizumab

Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.

Other Name: Keytruda

Experimental: Combination Expansion Cohort Melanoma

Patients will be treated with INBRX-105 in combination with Pembrolizumab.

Drug: INBRX-105 – PDL1x41BB antibody

The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Drug: Pembrolizumab

Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.

Other Name: Keytruda

Experimental: Combination Expansion Cohort Cohort PD-L1 Positive Basket

Patients with head and neck squamous cell carcinoma, gastro-esophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma will be treated with INBRX-105 in combination with Pembrolizumab.

Drug: INBRX-105 – PDL1x41BB antibody

The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Drug: Pembrolizumab

Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.

Other Name: Keytruda

Experimental: Combination Expansion Cohort CPI Naive Non-small Cell Lung Cancer

CPI naive patients (PD-L1 IHC between 1 and 49%) will be treated with INBRX-105 in combination with Pembrolizumab.

Drug: INBRX-105 – PDL1x41BB antibody

The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Drug: Pembrolizumab

Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.

Other Name: Keytruda

Experimental: Combination Expansion Cohort CPI Naive HNSCC

CPI naive patients (PD-L1 IHC >50%) will be treated with INBRX-105 in combination with Pembrolizumab.

Drug: INBRX-105 – PDL1x41BB antibody

The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Experimental: Combination Expansion Cohort HNSCC

CPI refractory/relapsed CPI patients (PD-L1 IHC >50%) will be treated with INBRX-105 in combination with Pembrolizumab.

Drug: INBRX-105 – PDL1x41BB antibody

The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.

Drug: Pembrolizumab

Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.

Other Name: Keytruda

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

January 31, 2023Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine
Diagnostic Tests in Supra-Esophageal Gastroesophageal Reflux Disease (SE-GERD)

Study subjects: we will study gastroesophageal reflux disease (GERD) patients with complaint of regurgitation and one of the following supra-esophageal symptoms attributed to reflux of gastric content: chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis and dental erosion i.e. Supraesophageal gastroesophageal reflux disease (SE-GERD). The presence of GERD will be verified in their records by result of prior endoscopy or pH monitoring within the past two years. It not, they will undergo transnasal esophagogastroduodenoscopy (T-EGD). If negative, they will undergo pH monitoring off medications to ascertain presence of GERD according to clinically accepted criteria (AGA guidelines (39). We will not enroll patients with functional heartburn (Rome III criteria (40). For Supra-esophageal complications we will use the endoscopic criteria used in clinical Ear, Nose and Throat (ENT) practice and validated symptom severity index questionnaire (developed by Belafsky et al) with the help of our otolaryngologist co-investigator Dr. Joel Blumin.

Justification of study subjects and endo-detection of pharyngeal reflux: because so much is unknown about Upper Esophageal Sphincter (UES) incompetence in various patient groups and lack of a gold standard reliable method for documentation of pharyngeal reflux, we had to make the following decision based on our preliminary studies to fulfill the goals of this project efficiently: a. in order to be able to study adequate number of pharyngeal reflux events in a manageable number of participants we chose GERD patients with complaint of regurgitation and supra-esophageal symptoms because of their high likelihood of developing pharyngeal reflux based on our preliminary studies and b. to avoid any doubt about occurrence of pharyngeal reflux which is inherent to pH and impedance monitoring due to their recording from a small section of the pharynx which may not be affected by refluxes of small volume in addition to their performance ambiguity in the pharynx, we chose to use endoscopic visualization of the refluxate after developing this technique as our gold standard.

Study position: studies will be done in supine postures due to vulnerability of the airway in this position.

Instrumentation: all instrumentations will be trans-nasal following application of 2% lidocaine limited to the nasal cavity.

Study technique: concurrent video-pharyngo-laryngoscopy and combined high-resolution manometry and impedance recording along with pH monitoring.

All study participants will give written informed consent followed by filling out a general health questionnaire. Additionally, a Belafsky Index will also be filled out in the same session by the study participant to assess the level of symptoms within the last month associated with supraesophageal reflux.

Combined manometric/impedance/pH recording: we will use combined solid-state high resolution manometry and impedance catheter with 36 circumferential pressure sensors, spaced 1 cm apart (Sierra Scientific, Los Angeles, CA) 18 impedance sensor couplets spaced 2 cm apart measuring at a sample rate of 40 Hz (Given Imaging Duluth, GA), 3 pH sensors spaced 7 and 10 cm respectively. The catheter will be introduced transnasally in a fashion that at least 3 proximal manometric sensors are in the pharynx and two impedance and one pH sensors are located 2 cm proximal to upper margin of UES in the pharynx. With this arrangement 3-4 manometric and one or two impedance couplets will be positioned in the UES high pressure zone while the remaining pressure sensors will cover the sub-sphincteric striated segment and the rest of esophagus along with lower esophageal sphincter (LES) through very proximal portion of stomach, although in very tall participants the full length of LES may not be covered. One ph sensor will be 3cm distal to UES while the remaining impedance couplets will span the proximal and distal esophagus.

Concurrent videopharyngo-laryngoscopy: to monitor concurrently the pharynx and larynx for entry of simulated refluxate we will use a Pentax FNL-10AP laryngopharyngoscope passed through the other nostril and positioned within the pharynx such that the UES inlet, vocal cords and pyriform sinuses are visualized. The laryngopharyngoscopic images will be synchronized with manometric/impedance/pH recordings by importing and superimposing the endoscopic images onto high resolution manometric recordings. Using a specially designed timer (Thalner Electronics Labs, Inc, Ann Arbor, MI) time in hundredths of a second will be superimposed on the video images for durational analyses of endoscopic images.

Slow and rapid intraesophageal infusion: A 3 mm outer diameter injection tube will be placed through the same nostril in a fashion that the injection port will be located 5-7cm above the manometrically determined upper border of lower esophageal sphincter (LES). With this arrangement gastroesophageal reflux events will be simulated by intra-esophageal injection of body temperature infusates namely,1/2 normal saline (its ionic nature helps impedance recording and identification of intra-esophageal distribution), 0.1 N HCl. As stated above infusions will be done in three sessions. Slow acid and slow1/2saline sessions will test two volumes (20 and 60ml) and two rates (.05 and 1.0 ml pre second). Since our preliminary data suggest a strong differentiating capacity for slow infusion (1ml/sec) in uncovering UES abnormalities we propose to test two slow infusions to identify the one with most differentiating capacity. We study slow acid and saline perfusion in two sessions to avoid the issue of esophageal sensitization effect on saline distension in addition to reasons describe above. The rapid injection session will test two volumes (20 and 60 ml) and one rate (10 ml per second). In this session we will test both acid and saline due to short contact time of the acid which make the sensitization less likely. A modified Harvard pump will be used for infusions. Each infusion will be repeated three times. The order of infused material as well as the volume of infused material in all sessions will be randomized. Also randomized, will be the three different study sessions. Liquid infusates will be colored green using food dye for ease of recognition of pharyngeal reflux. Exact timing and type of the injection will be documented using the event marker feature of the Manoscan® system. Each perfusion will be performed only when the UES, esophagus and LES are at baseline for at least three tidal volume respiratory cycles and 20s after a preceding peristaltic event. After each perfusion, manometry will be carefully monitored for 20s and then subjects will be cued to swallow and clear their esophageal contents. Esophageal clearance will be verified by the presence of an effective peristalsis and return of intra-esophageal impedance and pressure to baseline. As stated above infusions will be done in three sessions within the same two hour study visit.. Endoscopic views of pharynx will be watched carefully during infusions. At the first sign of reflux, perfusion will be stopped and participants will be instructed to swallow to avoid any potential airway compromise. This technique has been used in our laboratory for the past three years without any problem.

Pressure Data Analysis: All pressure measurements will be recorded at a 35HZ frequency and measured in reference to the atmospheric pressure UES and LES pressures will be measured utilizing the e-sleeve function of the Manoview ® software. All UES, LES and esophageal baseline pressures will be measured as peaks and troughs over 3 tidal volume respiratory cycles at stable resting conditions when no pharyngeal, gastric, esophageal, UES or LES events are present. Type, frequency, amplitude, onset, and duration of the UES response along with the LES and esophageal body response will be recorded.

UES pressure response to intraesophageal infusion: Percent UES relaxation and percent UES contraction will be calculated as a fraction of the maximum possible relaxation (baseline UES pressure-proximal esophageal pressure) and as a fraction of the maximum UES contraction pressure, respectively. UES relaxation will be considered complete (100%) if an audible belch is documented or the nadir UES pressure at least equalizes to the proximal esophageal pressure. Due to considerable variability of the resting UES pressure even at rest we have set a conservative threshold (10 mmHg) for determining the UES response (43-44). UES response will be categorized as an ordinal variable: contraction (UES pressure exceeds the peak baseline pressure by more than 10 mmHg); relaxation (UES pressure drops more than 10 mmHg below baseline trough pressure); or no response. It has been observed that often prior to and almost always after a swallow related UES relaxation (as UES participates in pharyngoesophageal peristaltic wave) there is an increase in UES tone that has been linked to the preceding relaxation rather than an independent event therefore, we will consider the UES contraction as a response only if it is not preceded by a UES relaxation response and not followed by UES relaxation within 3 seconds.

Extent of esophageal intraluminal pressure increase during infusions: will be recorded as an ordinal variable: 1) if esophageal pressure increase more than 3 mmHg above baseline during perfusion, esophageal pressure and peak rate of pressure increase (dp/dt) within a 0.1 s window will be measured during the perfusion in the proximal and distal esophageal segments as continuous variables.

Esophageal clearing response to intra-esophageal perfusion: will be classified into four categories: 1/ simultaneous esophageal contraction (>20 mmHg); 2/ secondary peristalsis as a sequential esophageal contraction of at least 5cm length and amplitude greater than 20 mmHg without preceding swallow related pharyngeal contraction); 3/ primary peristalsis (>20 mmHg) as an orderly sequential esophageal contraction of at least 5cm length and amplitude greater than 20 mmHg preceded by pharyngeal contraction and UES relaxation ; and, 4/ no response as the esophageal body pressure changes less than 20 mmHg or 5cm length during 20 second analysis window. We will monitor clearance of the infusate from esophagus by impedance monitoring up to 60 seconds and then subjects will be instructed to swallow until esophageal contents clear.

LES response to intraesophageal perfusion: Although LES function is not the center of present proposal when available its response to infusion will be classified into three types: 1/ complete relaxation defined as equalization of the LES pressure to gastric pressure; 2/ partial relaxation defined as a pressure drop > 5 mmHg; and, 3/ no response. The predominant UES, LES and esophageal response will be considered mode of three trials and recorded as an ordinal variable.

Videoendoscopic data analysis: onset of the entry of colored refluxate into the pharynx though the UES inlet will be determined and correlated with the UES, esophageal and LES pressure phenomena, impedance and pH events. Endoscopic documentation of pharyngeal reflux will be considered the gold standard and impedance and pH data will be compared to it.

Identification of biologic events: Glottal kinetics and movements as well as changes in the geometry of pharyngeal cavity will be used to identify swallow esophago-glottal closure reflex and belch. Belch and swallow will also be identified by their characteristic pressure and impedance signatures, investigator observation and participant signaling using a marker and correlated with endoscopic findings for certainty.

Criteria for abnormal UES barrier function: Based on our preliminary data these include, presence of one or any constellation of the following: absence of sustained UES contraction, transient partial or complete relaxation. Additional criteria may include absence of striated esophagus peristalsis or absence of secondary peristalsis. Presence of simultaneous contraction or lack any contraction. These criteria will be applied to infusion period (60 sec) plus two minute post-infusion.

Criteria for normal UES barrier function: sustained contraction of at least 20mmHg above pre-infusion period (three respiratory cycles) in response to infusion for the duration of infusion and lack of the abnormal criteria stated above.

Determine the ability of externally applied cricoids cartilage pressure on preventing pharyngeal reflux: Our preliminary studies have shown that externally applied pressure on the cricoid cartilage (20mmHg) can increase the intraluminally recorded UES pressure. These studies have also shown that this technique can prevent experimentally induced pharyngeal reflux in patients with SE-GERD and regurgitation. UES high pressure zone ranges from 3-4cm and is generated by participation of inferior pharyngeal constrictor, cricopharyngeus muscle and most proximal part of the esophagus. The spatial relationship of externally applied pressure and the UES pressure profile has not been studied. It is also not known whether external pressures applied, not exactly on the cricoid could impart the same effect. Our preliminary data suggests location dependent effect on UES pressure profile. Because this approach may have practical clinical ramification, in this sub-aim, we will characterize the effect of a 20mmHg pressure, externally applied to and several points distal and proximal to the cricoid cartilage on UES pressure profile. We have chosen 20 mmHg pressure based on our preliminary data. This procedure will be performed on all EPR patients recruited into our study. Each apparatus for exerting external cricoid pressure is custom fitted for each subject at the time of the study. Furthermore, the ICF for this protocol has been edited to include this procedure in the description of test performed during each experiment

Determine and characterize the effect of externally applied cricoid cartilage pressure on related functions such as belch and swallow: We will test dry, 5 and 10 ml ½ saline swallowsX3 in random order. In addition we will test belching by injecting various volumes of air into the esophagus through the previously paced infusion catheter. We will test 20 and 40 ml room TX3. Studies will be done with and without application of cricoid pressure. Cricoid pressure will be applied at 20mmHg by using our laboratory made neck band as described above with the exception that the pressure bar will be 10X30mm to cover the width of the cricoid cartilage for maximum effect. These studies will be carried out with the test subjects in the upright and supine positions.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

January 26, 2023Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine
Mechanisms Preventing Pharyngeal Reflux
Active Comparator: GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD)

GERD patients with complaint of regurgitation and one of the following supra-esophageal symptoms attributed to reflux of gastric content: chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis and dental erosion i.e. SE-GERD. Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy

Combined manometric/impedance/pH recording: we will use combined solid-state high-resolution manometry and impedance catheter with 36 circumferential pressure sensors, spaced 1 cm apart, 18 impedance sensor couplets spaced 2 cm apart, 3 pH sensors spaced 7 and 10 cm respectively. The catheter will be introduced trans-nasally.

Concurrent video-pharyngo-laryngoscopy: to monitor concurrently the pharynx and larynx for entry of simulated refluxate we will use a laryngo-pharyngo-scope passed through the other nostril and positioned within the pharynx such that the UES inlet, vocal cords and pyriform sinuses are visualized. The laryngo-pharyngo-scope images will be synchronized with manometric/impedance/pH recordings by importing and superimposing the endoscopic images onto high resolution manometric recordings. A specially designed timer will be superimposed on the video images for durational analyses of endoscopic images.

Diagnostic Test: Slow and rapid intra-esophageal infusion

A 3 mm outer diameter injection tube will be placed through the nose in a fashion that the injection port will be located 5-7cm above the manometrically determined upper border of lower esophageal sphincter (LES). With this arrangement gastroesophageal reflux events will be simulated by intra-esophageal injection of body temperature1/2 normal saline (its ionic nature helps impedance recording and identification of intra-esophageal distribution), 0.1 N HCl. Infused liquid will be colored green using food dye for ease of recognition of pharyngeal reflux. Esophageal clearance will be verified by the presence of an effective peristalsis and return of intra-esophageal impedance and pressure to baseline. Endoscopic views of pharynx will be watched carefully during infusions. At the first sign of reflux, perfusion will be stopped, and participants will be instructed to swallow to avoid any potential airway compromise.

Active Comparator: Age and gender matched healthy controls

Controls will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy

Combined manometric/impedance/pH recording: we will use combined solid-state high-resolution manometry and impedance catheter with 36 circumferential pressure sensors, spaced 1 cm apart, 18 impedance sensor couplets spaced 2 cm apart, 3 pH sensors spaced 7 and 10 cm respectively. The catheter will be introduced trans-nasally.

Concurrent video-pharyngo-laryngoscopy: to monitor concurrently the pharynx and larynx for entry of simulated refluxate we will use a laryngo-pharyngo-scope passed through the other nostril and positioned within the pharynx such that the UES inlet, vocal cords and pyriform sinuses are visualized. The laryngo-pharyngo-scope images will be synchronized with manometric/impedance/pH recordings by importing and superimposing the endoscopic images onto high resolution manometric recordings. A specially designed timer will be superimposed on the video images for durational analyses of endoscopic images.

Diagnostic Test: Slow and rapid intra-esophageal infusion

A 3 mm outer diameter injection tube will be placed through the nose in a fashion that the injection port will be located 5-7cm above the manometrically determined upper border of lower esophageal sphincter (LES). With this arrangement gastroesophageal reflux events will be simulated by intra-esophageal injection of body temperature1/2 normal saline (its ionic nature helps impedance recording and identification of intra-esophageal distribution), 0.1 N HCl. Infused liquid will be colored green using food dye for ease of recognition of pharyngeal reflux. Esophageal clearance will be verified by the presence of an effective peristalsis and return of intra-esophageal impedance and pressure to baseline. Endoscopic views of pharynx will be watched carefully during infusions. At the first sign of reflux, perfusion will be stopped, and participants will be instructed to swallow to avoid any potential airway compromise.

Active Comparator: Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint)

Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint). Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy

Combined manometric/impedance/pH recording: we will use combined solid-state high-resolution manometry and impedance catheter with 36 circumferential pressure sensors, spaced 1 cm apart, 18 impedance sensor couplets spaced 2 cm apart, 3 pH sensors spaced 7 and 10 cm respectively. The catheter will be introduced trans-nasally.

Concurrent video-pharyngo-laryngoscopy: to monitor concurrently the pharynx and larynx for entry of simulated refluxate we will use a laryngo-pharyngo-scope passed through the other nostril and positioned within the pharynx such that the UES inlet, vocal cords and pyriform sinuses are visualized. The laryngo-pharyngo-scope images will be synchronized with manometric/impedance/pH recordings by importing and superimposing the endoscopic images onto high resolution manometric recordings. A specially designed timer will be superimposed on the video images for durational analyses of endoscopic images.

Diagnostic Test: Slow and rapid intra-esophageal infusion

A 3 mm outer diameter injection tube will be placed through the nose in a fashion that the injection port will be located 5-7cm above the manometrically determined upper border of lower esophageal sphincter (LES). With this arrangement gastroesophageal reflux events will be simulated by intra-esophageal injection of body temperature1/2 normal saline (its ionic nature helps impedance recording and identification of intra-esophageal distribution), 0.1 N HCl. Infused liquid will be colored green using food dye for ease of recognition of pharyngeal reflux. Esophageal clearance will be verified by the presence of an effective peristalsis and return of intra-esophageal impedance and pressure to baseline. Endoscopic views of pharynx will be watched carefully during infusions. At the first sign of reflux, perfusion will be stopped, and participants will be instructed to swallow to avoid any potential airway compromise.

Active Comparator: Asthma patients with and without supra-esophageal symptoms

Asthma patients with and without supra-esophageal symptoms (these symptoms include chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis, and dental erosion). Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy

Combined manometric/impedance/pH recording: we will use combined solid-state high-resolution manometry and impedance catheter with 36 circumferential pressure sensors, spaced 1 cm apart, 18 impedance sensor couplets spaced 2 cm apart, 3 pH sensors spaced 7 and 10 cm respectively. The catheter will be introduced trans-nasally.

Concurrent video-pharyngo-laryngoscopy: to monitor concurrently the pharynx and larynx for entry of simulated refluxate we will use a laryngo-pharyngo-scope passed through the other nostril and positioned within the pharynx such that the UES inlet, vocal cords and pyriform sinuses are visualized. The laryngo-pharyngo-scope images will be synchronized with manometric/impedance/pH recordings by importing and superimposing the endoscopic images onto high resolution manometric recordings. A specially designed timer will be superimposed on the video images for durational analyses of endoscopic images.

Diagnostic Test: Slow and rapid intra-esophageal infusion

A 3 mm outer diameter injection tube will be placed through the nose in a fashion that the injection port will be located 5-7cm above the manometrically determined upper border of lower esophageal sphincter (LES). With this arrangement gastroesophageal reflux events will be simulated by intra-esophageal injection of body temperature1/2 normal saline (its ionic nature helps impedance recording and identification of intra-esophageal distribution), 0.1 N HCl. Infused liquid will be colored green using food dye for ease of recognition of pharyngeal reflux. Esophageal clearance will be verified by the presence of an effective peristalsis and return of intra-esophageal impedance and pressure to baseline. Endoscopic views of pharynx will be watched carefully during infusions. At the first sign of reflux, perfusion will be stopped, and participants will be instructed to swallow to avoid any potential airway compromise.

Active Comparator: Age and gender matched patient controls for diagnosed Barrett’s esophagus patients

Patient controls for diagnosed Barrett’s esophagus patients. Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy

Combined manometric/impedance/pH recording: we will use combined solid-state high-resolution manometry and impedance catheter with 36 circumferential pressure sensors, spaced 1 cm apart, 18 impedance sensor couplets spaced 2 cm apart, 3 pH sensors spaced 7 and 10 cm respectively. The catheter will be introduced trans-nasally.

Concurrent video-pharyngo-laryngoscopy: to monitor concurrently the pharynx and larynx for entry of simulated refluxate we will use a laryngo-pharyngo-scope passed through the other nostril and positioned within the pharynx such that the UES inlet, vocal cords and pyriform sinuses are visualized. The laryngo-pharyngo-scope images will be synchronized with manometric/impedance/pH recordings by importing and superimposing the endoscopic images onto high resolution manometric recordings. A specially designed timer will be superimposed on the video images for durational analyses of endoscopic images.

Diagnostic Test: Slow and rapid intra-esophageal infusion

A 3 mm outer diameter injection tube will be placed through the nose in a fashion that the injection port will be located 5-7cm above the manometrically determined upper border of lower esophageal sphincter (LES). With this arrangement gastroesophageal reflux events will be simulated by intra-esophageal injection of body temperature1/2 normal saline (its ionic nature helps impedance recording and identification of intra-esophageal distribution), 0.1 N HCl. Infused liquid will be colored green using food dye for ease of recognition of pharyngeal reflux. Esophageal clearance will be verified by the presence of an effective peristalsis and return of intra-esophageal impedance and pressure to baseline. Endoscopic views of pharynx will be watched carefully during infusions. At the first sign of reflux, perfusion will be stopped, and participants will be instructed to swallow to avoid any potential airway compromise.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

January 26, 2023Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
Mayo Clinic Phoenix, Arizona, United States, 85054 UCLA Santa Monica, California, United States, 90024 SCRI – Florida Cancer Specialists – North Region Research Office Fort Myers, Florida, United States, 33901 SCRI – Florida Cancer Specialists – South Region Research Office Saint Petersburg, Florida, United States, 33705 Massachusetts General Hospital Boston, Massachusetts, United States, 02109 New York-Presbyterian Columbia University Medical Center New York, New York, United States, 10032 Memorial Sloan Kettering Cancer Center New York, New York, United States, 10065 Zangmeister Cancer Center Columbus, Ohio, United States, 43219 Greenville Health System Cancer Institute (Prisma) Spartanburg, South Carolina, United States, 29307 SCRI Tennessee Oncology – Nashville Nashville, Tennessee, United States, 37203 Virginia Cancer Specialists-Fairfax Office Fairfax, Virginia, United States, 22031 Institut Bergonié Bordeaux, France CHU de Brest_Brest Brest, France Centre François Baclesse Caen, France Hôpital Timone Marseille, France Institut de Recherche en Cancerologie de Montpellier Montpellier, France Centre Armoricain de Radiothérapie, d’Imagerie Médicale et d’Oncologie Plérin, France Pôle Régional de Cancérologie – Service d’Oncologie Médicale – Poitiers Poitiers, France Dong-A University Hospital Busan, Korea, Republic of Kyungpook National University Chilgok Hospital Daegu, Korea, Republic of Chonnam National University Hwasun Hospital Hwasun, Korea, Republic of CHA Bundang Medical Center Seongnam, Korea, Republic of Asan Medical Center Hospital Seoul, Korea, Republic of Korea University Guro Hospital Seoul, Korea, Republic of Samsung Medical Center Seoul, Korea, Republic of Seoul National University Hospital Seoul, Korea, Republic of Severance Hospital Cancer Center Seoul, Korea, Republic of

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

January 24, 2023Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine
A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors

Part A of the trial will consist of two cohorts, one dosed every 2 weeks and one dosed every 3 weeks in a standard 3+3 design. Part A is the dose finding portion of the trial.

18 to 36 participants will be enrolled.

Part B consists of 3 cohorts:

Cohort A is for patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma. Patients will receive TST001 at 2mg/kg or 4mg/kg Q2W plus Nivolumab and mFOLFOX6. Alternative allocation of patients between the 2 doses will be performed. The first 6 patients at each dose level as the lead-in phase will not be selected on the basis of their tumor’s CLDN18.2 expression. Approximately 12-42 patients will be enrolled in Cohort A.

Cohort B is for patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies. Patient will receive TST001 plus Nivolumab. No selection based on CLDN18.2 expression will be required for the safety run-in (3-6 patients). Patients with CLDN18.2 expression in tumor tissue tested by the central laboratory will be enrolled in the expansion phase. Safety run-in phase will follow 3+3 rule with two dose levels, TST001 3mg/kg and 6mg/kg Q3W combined with nivolumab. Approximately 30 patients will be enrolled in Cohort B including the patients in the safety run-in phase.

Cohort C is for patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma; Patients will receive TST001 at 2mg/kg or 4mg/kg Q2W plus gemcitabine and albumin-bound paclitaxel. Alternative allocation of patients between the 2 doses will be performed. The first 6 patients at each dose level as the lead-in phase will not be selected on the basis of their tumor’s CLDN18.2 expression. Approximately 12-42 patients will be enrolled in Cohort C.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

January 21, 2023Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
Research Site Los Angeles, California, United States, 90095 Research Site San Diego, California, United States, 92103 Research Site Santa Rosa, California, United States, 95403 Research Site Indianapolis, Indiana, United States, 46202 Research Site Kansas City, Kansas, United States, 66160 Research Site Boston, Massachusetts, United States, 02114 Research Site Boston, Massachusetts, United States, 02215 Research Site Grand Rapids, Michigan, United States, 49503 Research Site Albuquerque, New Mexico, United States, 87109 Research Site Commack, New York, United States, 11725 Research Site Cincinnati, Ohio, United States, 45219 Research Site Columbus, Ohio, United States, 43219 Research Site Portland, Oregon, United States, 97239 Research Site Nashville, Tennessee, United States, 37203 Research Site Nashville, Tennessee, United States, 37232 Research Site Houston, Texas, United States, 77030 Research Site Madison, Wisconsin, United States, 53792 Research Site Toronto, Ontario, Canada, M4N 3M5 Research Site Toronto, Ontario, Canada, M5G 2M9 Research Site Montreal, Quebec, Canada, H2X 3J4 Research Site Montreal, Quebec, Canada, H3G 1A4 Research Site Quebec, Canada, G1L 3L5 Research Site Changsha, China, 410013 Research Site Chongqing, China, 400030 Research Site Guangzhou, China, 510060 Research Site Guangzhou, China, 510120 Research Site Hangzhou, China, 310020 Research Site Hefei, China, 230001 Research Site Shanghai, China, 200032 Research Site Shenyang, China, 110016 Research Site Wuhan, China, 430030 Research Site Wuhan, China, 430079 Research Site Xi’an, China, 710000 Research Site Zhengzhou, China, 450052 Research Site Bordeaux, France, 33076 Research Site Lyon, France, 69373 Research Site Marseille, France, 13273 Research Site Suresnes, France, 92150 Research Site Berlin, Germany, 10117 Research Site Essen, Germany, 45136 Research Site Hannover, Germany, 30625 Research Site München, Germany, 81377 Research Site Regensburg, Germany, 93053 Research Site Firenze, Italy, 50139 Research Site Genova, Italy, 16132 Research Site Milano, Italy, 20132 Research Site Milano, Italy, 20162 Research Site Milan, Italy, 20141 Research Site Napoli, Italy, 80131 Research Site Rome, Italy, 00168 Research Site Chuo-ku, Japan, 104-0045 Research Site Kashiwa, Japan, 277-8577 Research Site Koto-ku, Japan, 135-8550 Research Site Nagoya-shi, Japan, 464-8681 Research Site Shinagawa-ku, Japan, 142-8666 Research Site Suita-shi, Japan, 565-0871 Research Site Seodaemun-gu, Korea, Republic of, 03722 Research Site Seoul, Korea, Republic of, 03080 Research Site Seoul, Korea, Republic of, 06351 Research Site Seoul, Korea, Republic of, 5505 Research Site Kraków, Poland, 30-688 Research Site Poznań, Poland, 61-866 Research Site Warszawa, Poland, 02-781 Research Site Łódź, Poland, 92-213 Research Site Barcelona, Spain, 08035 Research Site Cordoba, Spain, 14004 Research Site Madrid, Spain, 28046 Research Site Málaga, Spain, 29010 Research Site Pamplona, Spain, 31008 Research Site Sevilla, Spain Research Site Basel, Switzerland, 4031 Research Site Bellinzona, Switzerland, 6500 Research Site St. Gallen, Switzerland, 9007 Research Site Liou Ying Township, Taiwan, 736 Research Site Taipei, Taiwan, 100 Research Site Taipei, Taiwan, 11259 Research Site Taipei, Taiwan, 112 Research Site Taoyuan, Taiwan, 333 Research Site Ankara, Turkey, 06620 Research Site Ankara, Turkey, 06800 Research Site Edirne, Turkey, 22030 Research Site Kadıkoy/Istanbul, Turkey, 34722 Research Site Karsiyaka, Turkey, 35575 Research Site Konya, Turkey, 42080 Research Site Pamukkale, Turkey, 20070 Research Site Samsun, Turkey Research Site Cambridge, United Kingdom, CB2 0QQ Research Site Dundee, United Kingdom, DD1 9SY Research Site London, United Kingdom, NW1 2PG Research Site London, United Kingdom, SE1 9RT Research Site Manchester, United Kingdom, M20 4BX

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

January 18, 2023Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine
Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility
Control

No diagnosis of gastroparesis, functional dyspepsia, or prior G-POEM

Device: Magnetically Controlled Capsule Endoscopy

This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

January 12, 2023Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine
A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
Northport Veterans Affairs Medical Center Northport, New York, United States, 11768 Ogaki Municipal Hospital Ogaki-shi, Gifu, Japan, 503-8502 St Marianna University Hospital Kawasaki-shi, Kanagawa, Japan, 216-8511 Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center Yokohama-shi, Kanagawa, Japan, 241-8515 Shizuoka Cancer Center Sunto-gun, Shizuoka, Japan, 411-8777 National Cancer Center Hospital Chuo-ku, Tokyo, Japan, 104-0045 Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620 Seoul National University Hospital Seoul, Korea, Republic of, 03080 Severance Hospital Yonsei University Health System Seoul, Korea, Republic of, 03722 Asan Medical Center Seoul, Korea, Republic of, 05505 Samsung Medical Center Seoul, Korea, Republic of, 06351 National University Hospital Singapore, Singapore, 119074 National Taiwan University Hospital Taipei, Taiwan, 10002 Taipei Veterans General Hospital Taipei, Taiwan, 11217

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

January 7, 2023Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine
Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers
Experimental: HR deficient cohort

Pre-identified presence of somatic or germline deleterious mutation, as determined by NGS only, in at least one gene critical to DNA repair through homologous recombination, including but not limited to: ARID1A, ATM, ATRX, MRE11A, NBN, PTEN, RAD50/51/51B, BARD1, BLM, BRCA1, BRCA2, BRIP1, FANCA/C/D2/E/F/G/L, PALB2, WRN, CHEK2, CHEK1, BAP1, FAM175A, SLX4, MLL2 or XRCC.

Drug: Pembrolizumab

Pembrolizumab 200mg IV every 3 weeks starting C2D1

Other Name: Keytruda

Drug: Olaparib

Olaparib 200mg orally twice daily starting C1D1 concurrently with radiation. Starting C2D1, Olaparib 300mg orally twice with Pembrolizumab

Other Name: Lynparza

Radiation: Stereotactic Body Radiation Therapy

Stereotactic Body Radiation Therapy Dose 25Gy in 5 fractions daily (M-F) for 5 days starting C1D1 with Olaparib

Other Name: SBRT

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

January 6, 2023Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine
A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

This is a Phase 1a/b, first in human, open-label, dose escalation and expansion study in adults with advanced cancers. The study will comprise of

  1. A Screening Period of up to 28 days
  2. A Treatment Period during which participants will receive the study drug on the first day of each cycle where each cycle is 28 days. Number of cycles depends on how the disease responds to the study drug
  3. A Follow-up Period which involves 1 visit for single agent and 2 visits for combination.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

December 28, 2022Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine