Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors
Recruiting now · Phase 1
Conditions studied: Solid Tumors, Sarcomas
In brief
The purpose of this study is to evaluate the safety and tolerability of investigational study drug ZL-6201 for treating sarcoma and solid tumors cancer.
Key facts
- Study ID
- NCT07374848
- Run by
- Zai Lab (Shanghai) Co., Ltd.
- People needed
- 180
- Starts
- 2026-03-02
- Expected to finish
- 2029-09-01
- Last updated by the study team
- 2026-07-23
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 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
You may not qualify if…
- 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 is running
- Zai Lab Site 02003 — Los Angeles, California, United States (enrolling)
- Zai Lab Site 02030 — New Haven, Connecticut, United States (enrolling)
- Zai Lab Site 02026 — Sarasota, Florida, United States (enrolling)
- Zai Lab Site 02005 — St Louis, Missouri, United States (enrolling)
- Zai Lab Site 02002 — New York, New York, United States (enrolling)
- Zai Lab Site 02006 — Fairfax, Virginia, United States (enrolling)
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
- Shanghai East Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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