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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 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. |
| ClinicalTrials.gov Identifier: NCT05859464 |
|
Recruitment Status : **RECRUITING NOW**
First Posted : May 16, 2023 Last Update Posted : May 16, 2023 |
Sponsor:
Zai Lab (Hong Kong), Ltd.
Collaborator:
Zai Biopharmaceutical (Suzhou) Co., Ltd.
Information provided by (Responsible Party):
Zai Lab (Hong Kong), Ltd.
Study Description
Brief Summary:
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ZL-1218 as a single agent and as combination therapy in subjects with advanced solid tumor malignancies.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Malignant Solid Tumor | Drug: ZL-1218 Drug: Pembrolizumab | Phase 1 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I, Open-label, Multicenter Study of ZL-1218 as a Single Agent and as Combination Therapy With Anti-PD-1 Antibody to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects With Advanced Solid Tumor Malignancies |
| Estimated Study Start Date : | May 31, 2023 |
| Estimated Primary Completion Date : | November 2024 |
| Estimated Study Completion Date : | November 2025 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| Experimental: ZL-1218 | Drug: ZL-1218
ZL-1218 dose escalation |
| Experimental: ZL-1218 in combination with Pembrolizumab | Drug: ZL-1218
ZL-1218 dose escalation Drug: Pembrolizumab Combination treatment with ZL-1218 |
Outcome Measures
- Incidence of Dose Limiting Toxicities [ Time Frame: Approximately 24 months ]
Number of subjects with dose limiting toxicities (DLTs)
- Incidence of Treatment Related Adverse Events [ Time Frame: Approximately 24 months ]
Number of subjects with treatment-emergent adverse effects
- Incidence of Serious adverse events [ Time Frame: Approximately 24 months ]
Number of subjects with Serious Adverse Events
- Clinically Significant changes in safety assessments [ Time Frame: Approximately 24 months ]
Changes in safety assessment parameters (e.g., vital signs, electrocardiograms [ECGs], and clinical laboratory results) .
- ORR per RECIST 1.1 [ Time Frame: up to 24 months ]
Objective Response Rate (ORR) per RECIST 1.1
- ORR per iRECIST [ Time Frame: up to 24 months ]
Objective Response Rate (ORR) per iRECIST
- Duration of Response per RECIST 1.1 [ Time Frame: up to 24 months ]
Duration of Response per RECIST 1.1
- Duration of Response per iRECIST [ Time Frame: up to 24 months ]
Duration of Response per iRECIST
- PFS per RECIST 1.1 [ Time Frame: up to 24 months ]
Progression-Free Survival (PFS) per RECIST 1.1
- PFS per iRECIST [ Time Frame: up to 24 months ]
Progression-Free Survival (PFS) per iRECIST
- DCR per RECIST 1.1 [ Time Frame: up to 24 months ]
Disease Control Rate (DCR) per RECIST 1.1
- DCR per iRECIST [ Time Frame: up to 24 months ]
Disease Control Rate (DCR) per iRECIST
- Overall Survival [ Time Frame: up to 24 months ]
Overall Survival (OS)
- Pharmacokinetics (PK): AUC [ Time Frame: up to 24 months ]
Area under curve (AUC)
- Pharmacokinetics (PK): Cmax [ Time Frame: up to 24 months ]
Maximum serum concentration (CMax)
- Pharmacokinetics (PK): Tmax [ Time Frame: up to 24 months ]
Time to reach Cmax (Tmax)
- Pharmacokinetics (PK): Ctrough [ Time Frame: up to 24 months ]
Ctrough
- Pharmacokinetics (PK): Vss [ Time Frame: up to 24 months ]
Volume of distribution as steady state (Vss)
- Pharmacokinetics (PK): CL [ Time Frame: up to 24 months ]
Clearance (CL)
- Pharmacokinetics (PK): t1/2 [ Time Frame: up to 24 months ]
Half-life (t1/2)
- Immunogenicity [ Time Frame: up to 24 months ]
Incidence of anti-drug antibodies (ADAs)
- Immunogenicity [ Time Frame: up to 24 months ]
Quantity of anti-drug antibodies (ADAs)
Eligibility Criteria
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult men and women ≥ 18 years of age. If 18 years is not the age of majority, then adult men and women ≥ age of majority per local regulation.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Subjects must have histologically confirmed and documented diagnosis of locally advanced unresectable or metastatic advanced solid tumor that is refractory to standard treatment, or intolerant to standard treatment, or for which no standard treatment exists.
- Subjects must have at least one target lesion as defined by RECIST v1.1 on CT, PET/CT, or MRI scan.
- Subjects must have a site of disease which is safe and amenable to biopsy per the treating institution’s guidelines. Subjects must be willing to undergo a tumor biopsy at screening and on treatment, per the protocol guidelines.
Exclusion Criteria:
- Symptomatic or uncontrolled brain metastasis requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids.
- Prior exposure to CCR8 inhibitor (anti-CCR8 antibody) or hypersensitivity to any ingredient of the study drug.
- Out of range value at screening and before the first dose of study treatment
- Subjects have received a live vaccine within 30 days of planned start of study therapy.
- Subjects with known history of, or any evidence of active, non-infectious pneumonitis.
- Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study drug
- Treatment with any systemic anti-cancer treatment (including investigational products) within 4 weeks before first dose of study drug
- Non-palliative radiotherapy within 4 weeks prior to first dose of study drug
- Major surgery within 4 weeks of the first dose of study drug
- Infections requiring systemic antibiotic therapy.
- Any medical conditions that would, in the investigator’s judgement, prevent the subject’s participation in the clinical study due to safety concerns, compliance with the study procedures, or interpretation of the study results.
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05859464
Contacts
Locations
| United States, New Jersey | |
| Zai Lab Site 2001 | Not yet **RECRUITING NOW** |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Zai Lab Site 2002 | Not yet **RECRUITING NOW** |
| New York, New York, United States, 10029 | |
| United States, Washington | |
| Zai Lab Site 2003 | **RECRUITING NOW** |
| Spokane, Washington, United States, 99208 | |
Sponsors and Collaborators
Zai Lab (Hong Kong), Ltd.
Zai Biopharmaceutical (Suzhou) Co., Ltd.
More Information
| Responsible Party: | Zai Lab (Hong Kong), Ltd. |
| ClinicalTrials.gov Identifier: | NCT05859464 |
| Other Study ID Numbers: | Zl-1218-001 |
| First Posted: | May 16, 2023 Key Record Dates |
| Last Update Posted: | May 16, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
| Neoplasms Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents |
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.
