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

Last updated: January 16, 2025
Sponsor: Zai Lab (Hong Kong), Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

ZL-1218

Pembrolizumab

Clinical Study ID

NCT05859464
ZL-1218-001
KEYNOTE-F22
KEYNOTE-F22, MK-3475-F22
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult men and women ≥ 18 years of age. If 18 years is not the age of majority, thenadult 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 locallyadvanced unresectable or metastatic advanced solid tumor that is refractory tostandard treatment, or intolerant to standard treatment, or for which no standardtreatment exists.Subjects must have at least one target lesion as defined by RECISTv1.1 on CT, PET/CT, or MRI scan.

  • Subjects must have a site of disease which is not previously irradiated and is safeand amenable to biopsy per the treating institution's guidelines. Subjects must bewilling to undergo a tumor biopsy at screening and on treatment, per the protocolguidelines.

  • Subjects must have a site of disease which is not previously irradiated and is safeand amenable to biopsy per the treating institution's guidelines. Subjects must bewilling to undergo a tumor biopsy at screening and on treatment, per the protocolguidelines.

Exclusion

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 anyingredient 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 plannedstart of study therapy.

  • Subjects with known history of, or any evidence of active, non-infectiouspneumonitis.

  • 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 investigationalproducts) within 4 weeks before first dose of study drug.

  • Non-palliative radiotherapy within 2 weeks prior to first dose of study drug or havehad 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 thesubject's participation in the clinical study due to safety concerns, compliancewith the study procedures, or interpretation of the study results.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: ZL-1218
Phase: 1
Study Start date:
July 24, 2023
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Zai Lab Site 1002

    Hangzhou, 310009
    China

    Active - Recruiting

  • Zai Lab Site 1001

    Shanghai, 200123
    China

    Active - Recruiting

  • Zai Lab Site 8004

    Pozuelo De Alarcón, Madrid 28223
    Spain

    Active - Recruiting

  • Zai Lab Site 8001

    Barcelona, 8035
    Spain

    Active - Recruiting

  • Zai Lab Site 8005

    Barcelona, 8023
    Spain

    Active - Recruiting

  • Zai Lab Site 8007

    Madrid, 28040
    Spain

    Active - Recruiting

  • Zai Lab Site 8008

    Madrid, 28050
    Spain

    Active - Recruiting

  • Zai Lab Site 8003

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Zai Lab Site 8002

    Valencia, 46009
    Spain

    Active - Recruiting

  • Zai Lab Site 8006

    Valencia, 46010
    Spain

    Active - Recruiting

  • Zai Lab Site 2005

    Irvine, California 92618
    United States

    Active - Recruiting

  • Zai Lab Site 2007

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Zai Lab Site 2001

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Zai Lab Site 2002

    New York, New York 10029
    United States

    Active - Recruiting

  • Zai Lab Site 2003

    Spokane, Washington 99208
    United States

    Active - Recruiting

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