Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer

Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer
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 Nasopharyngeal or Oropharyngeal Carcinoma

Patients with head and neck squamous cell carcinoma (NPC or OPC) 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

CPI relapsed/refractory 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

CPI relapsed/refractory 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

CPI-relapsed/refractory 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.

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.

May 12, 2023Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine
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