Testing ZL-6201 for safety and early activity in sarcoma and other solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase 1a/b study gives escalating doses of ZL-6201 to adults with unresectable or metastatic sarcoma and selected solid tumors to characterize safety, tolerability, pharmacokinetics, and initial anti-tumor activity. Participants must have measurable disease, ECOG performance status 0–1, adequate organ and marrow function, be negative for HIV/HBV/HCV, and provide a tumor biopsy or archival tissue. The design includes dose-escalation followed by expansion cohorts in selected tumor types, with regular imaging per RECIST v1.1 and scheduled PK sampling. Safety events, lab results, and tumor responses will be tracked to establish a recommended dose for future studies.

Why it matters

Who can join: the full rules

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

Where it's running

• Zai Lab Site 02003
  Los Angeles, California, United States Recruiting
• Zai Lab Site 02030
  New Haven, Connecticut, United States Recruiting
• Zai Lab Site 02026
  Sarasota, Florida, United States Recruiting
• Zai Lab Site 02005
  St Louis, Missouri, United States Recruiting
• Zai Lab Site 02002
  New York, New York, United States Recruiting
• Zai Lab Site 02006
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: ZL-6201-001 Study Team
• Email: ZL-6201-001@zailaboratory.com
• Phone: 650.360.1601

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.