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

Stopped early · Phase 1

Conditions studied: Malignant Solid Tumor

In brief

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.

Key facts

Study ID: NCT05859464
Run by: Zai Lab (Hong Kong), Ltd.
People needed: 34
Starts: 2023-07-24
Expected to finish: 2025-08-28
Last updated by the study team: 2025-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Zai Lab Site 8008 — Madrid, Madrid, Spain
Zai Lab Site 8007 — Madrid, Madrid, Spain
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 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

Full record on ClinicalTrials.gov

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