A Phase 1 Study of ZL-1218 in Subjects With Advanced Solid Tumors

NCT ID: NCT05859464

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-24
• Study Completion Date: 2025-08-28

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.

Conditions

Malignant Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Dose Escalation; ZL-1218

Drug: ZL-1218 ZL-1218 dose escalation

Group Type: EXPERIMENTAL

ZL-1218

Intervention Type: DRUG

ZL-1218 dose escalation

Part 1: Dose Escalation; ZL-1218 in combination with Pembrolizumab

Drug: ZL-1218 ZL-1218 dose escalation

Drug: Pembrolizumab (KEYTRUDA®) Combination treatment with ZL-1218

Group Type: EXPERIMENTAL

ZL-1218

Intervention Type: DRUG

ZL-1218 dose escalation

Pembrolizumab

Intervention Type: DRUG

Combination treatment with ZL-1218

Part 2: Cohort Expansion; Prior CPI Therapy

Drug: ZL-1218 ZL-1218 recommended dose

Drug: Pembrolizumab (KEYTRUDA®) Combination treatment with ZL-1218

Group Type: EXPERIMENTAL

ZL-1218

Intervention Type: DRUG

ZL-1218 dose escalation

Pembrolizumab

Intervention Type: DRUG

Combination treatment with ZL-1218

Part 2: Cohort Expansion; CPI therapy Naive

Drug: ZL-1218 ZL-1218 recommended dose

Drug: Pembrolizumab (KEYTRUDA®) Combination treatment with ZL-1218

Group Type: EXPERIMENTAL

ZL-1218

Intervention Type: DRUG

ZL-1218 dose escalation

Pembrolizumab

Intervention Type: DRUG

Combination treatment with ZL-1218

Interventions

ZL-1218

ZL-1218 dose escalation

Intervention Type: DRUG

Pembrolizumab

Combination treatment with ZL-1218

Intervention Type: DRUG

Eligibility 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.
• Life expectancy > 12 weeks.
• 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 not previously irradiated and 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.
• Subjects must have a site of disease which is not previously irradiated and 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 within 10 days prior to the first dose of study treatment.
• Subjects have received a live or live-attenuated 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 2 weeks prior to first dose of study drug or have had history of radiation pneumonitis.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zai Biopharmaceutical (Shanghai) Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Zai Lab (Hong Kong), Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zai Lab Site 2005

Irvine, California, United States

Zai Lab Site 2007

Detroit, Michigan, United States

Zai Lab Site 2001

Hackensack, New Jersey, United States

Zai Lab Site 2002

New York, New York, United States

Zai Lab Site 2003

Spokane, Washington, United States

Zai Lab Site 1002

Hangzhou, , China

Zai Lab Site 1001

Shanghai, , China

Zai Lab Site 8005

Barcelona, Barcelona, Spain

Zai Lab Site 8001

Barcelona, Barcelona, Spain

Zai Lab Site 8007

Madrid, Madrid, Spain

Zai Lab Site 8008

Madrid, Madrid, Spain

Zai Lab Site 8004

Pozuelo de Alarcón, Madrid, Spain

Zai Lab Site 8003

Seville, Sevilla, Spain

Zai Lab Site 8002

Valencia, Valencia, Spain

Zai Lab Site 8006

Valencia, Valencia, Spain

Countries

United States; China; Spain

Other Identifiers

KEYNOTE-F22, MK-3475-F22

Identifier Type: OTHER

Identifier Source: secondary_id

ZL-1218-001

Identifier Type: -

Identifier Source: org_study_id