Early test of ZL-6201 in adults with sarcoma and other solid tumors
Tests the safety of ZL-6201 in adults with sarcoma and other solid tumors.
Plain-language title generated from the registry record
Registry title: Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors
Key facts
- Where
- Fairfax, Los Angeles, New Haven, New York, Sarasota, and St Louis, United StatesSee the 6 sites
- Phase
- Phase 1
Where in United States
- FairfaxFairfax, United StatesTaking people
- Los AngelesLos Angeles, United StatesTaking people
- New HavenNew Haven, United StatesTaking people
- New YorkNew York, United StatesTaking people
- SarasotaSarasota, United StatesTaking people
- St LouisSt Louis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zai Lab (Shanghai) Co., Ltd.
- Trial code
- NCT07374848
- Record updated
- 23 July 2026
- Original description
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.Read full original descriptionShow less
An Open-label, Phase 1a/b, Multicenter Study of ZL-6201 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Participants With Sarcoma and Selected Solid Tumors
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.
Inclusion: 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: Symptomatic central nervous system (CNS) metastasis, and/or those requiring therapy with corticosteroids or anticonvulsants to control associated symptoms; 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; Participants with another known malignancy that has required treatment within the last 2 years; Clinically significant pulmonary disease including autoimmune, connective tissue, or inflammatory conditions; Participants with leptomeningeal metastasis; Pregnant or nursing (lactating) women.