Actively Recruiting
Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors
Led by Zai Lab (Shanghai) Co., Ltd. · Updated on 2026-03-05
180
Participants Needed
2
Research Sites
182 weeks
Total Duration
On this page
Sponsors
Z
Zai Lab (Shanghai) Co., Ltd.
Lead Sponsor
Z
Zai Lab (US) LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men and women 18 years of age or older with ECOG performance status of 0 or 1 and life expectancy greater than 3 months
- Histologically confirmed diagnosis of locally advanced unresectable and/or metastatic sarcoma or selected solid tumor
- Willingness to undergo tumor biopsy before treatment or provide archived tumor tissue
- Sarcoma participants with no more than 2 prior systemic therapies in metastatic setting
- Selected solid tumor participants with no more than 3 prior systemic therapies in metastatic or relapsed refractory setting
- At least one measurable target lesion as defined by RECIST v1.1
- Adequate organ and marrow function as per protocol
- Negative test results for HIV, HBV, and HCV
You will not qualify if you...
- Another known malignancy requiring treatment within the last 2 years
- Symptomatic central nervous system metastasis or requiring corticosteroids/anticonvulsants for symptoms
- Leptomeningeal metastasis
- Systemic anti-cancer treatment or investigational products/devices within 3 weeks prior
- Prior treatment with topoisomerase-1 inhibitor antibody drug conjugate
- Impaired cardiac function or significant cardiac disease within 3 months before first dose
- Clinically significant pulmonary disease including autoimmune, connective tissue, or inflammatory conditions
- Pregnant or nursing (lactating) women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Zai Lab Site 02026
Sarasota, Florida, United States, 34232
Actively Recruiting
2
Zai Lab Site 02006
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
Z
ZL-6201-001 Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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