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Recruiting nowPhase 1Ages 18 Years and up

Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors

Sponsor: Zai Lab (Shanghai) Co., Ltd. · NCT07374848 on ClinicalTrials.gov ↗

Conditions studied

Solid TumorsSarcomas

What it tests

  • ZL-6201drug

Where it's running5 sites

  • Zai Lab Site 02003

    Los Angeles, California 90007

    Recruiting now
  • Zai Lab Site 02026

    Sarasota, Florida 34232

    Recruiting now
    • Site 02026(contact)
  • Zai Lab Site 02005

    St Louis, Missouri 63160

    Recruiting now
  • Zai Lab Site 02002

    New York, New York 10065

    Recruiting now
  • Zai Lab Site 02006

    Fairfax, Virginia 22031

    Recruiting now
    • Site 02006(contact)
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

Inclusion Criteria:

* Adult men and women ≥18 years of age at the time of signing the ICF with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy \> 3 months
* Participants must have histologically confirmed and documented diagnosis of locally advanced unresectable and/or metastatic sarcoma or a selected solid tumor
* Participants must be willing to undergo a tumor biopsy prior to start of treatment or provide archived tumor tissue sample
* Participants with sarcoma should have received no more than 2 lines of previous systemic therapies in the metastatic setting
* Participants with selected epithelial solid tumors should have received no more than 3 lines of previous systemic therapy in the metastatic/relapsed refractory setting
* Participants must have at least one measurable target lesion as defined by RECIST v1.1
* Adequate organ and marrow function as listed per protocol
* Must be negative for HIV, HBV, and HCV

Exclusion Criteria:

* Participants with another known malignancy that has required treatment within the last 2 years
* Symptomatic central nervous system (CNS) metastasis, and/or those requiring therapy with corticosteroids or anticonvulsants to control associated symptoms
* Participants with leptomeningeal metastasis
* Most recent systemic anti-cancer treatment or investigational products/devices less than 3 weeks
* Prior treatment with a topoisomerase-1 inhibitor antibody drug conjugate
* Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
* Clinically significant pulmonary disease including autoimmune, connective tissue, or inflammatory conditions
* Pregnant or nursing (lactating) women

Updated 2026-05-28 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.