Actively Recruiting
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
Led by Zai Lab (Shanghai) Co., Ltd. · Updated on 2026-05-28
180
Participants Needed
5
Research Sites
56 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
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of the investigational drug ZL-6201 in adults with sarcoma and selected solid tumors. This open-label, phase 1a/b, multicenter study focuses on participants with locally advanced unresectable or metastatic disease, aiming to understand how the drug behaves in the body and its potential effects in these cancers. Participants receive ZL-6201 as a single agent during the study. The treatment cycles last 21 days each, and the study includes monitoring for dose-limiting toxicities and adverse events over a 36-month period. The study also measures tumor response and progression using RECIST 1.1 criteria, with pharmacokinetic analyses of both the antibody-drug conjugate and unconjugated components. During the study, participants undergo tumor biopsies or provide archived tumor tissue samples, along with regular clinical laboratory tests, vital sign checks, and electrocardiograms to monitor safety. Researchers track side effects, treatment responses, and drug levels throughout the study and follow participants for up to 36 months to assess longer-term outcomes and safety. The total duration of participation may vary depending on individual treatment courses and assessments.
CONDITIONS
Brief 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 at the time of signing the informed consent form with ECOG performance status 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 prior to treatment or provide archived tumor tissue sample
- For sarcoma: no more than 2 prior systemic therapies in the metastatic setting
- For selected epithelial solid tumors: no more than 3 prior systemic therapies in the metastatic or relapsed refractory setting
- At least one measurable target lesion as defined by RECIST v1.1
- Adequate organ and marrow function as specified in the protocol
- Negative 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 need for corticosteroids or anticonvulsants for symptom control
- Presence of leptomeningeal metastasis
- Most recent systemic anti-cancer treatment or investigational product less than 3 weeks prior
- Prior treatment with a topoisomerase-1 inhibitor antibody drug conjugate
- Impaired cardiac function or significant cardiac disease within the last 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive ZL-6201 as a single-agent treatment to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy.
Visits occur each treatment cycle (every 3 weeks)
Duration - Up to 36 months
Participants are monitored for safety and treatment outcomes after completing treatment.
Regular visits during follow-up period
Trial Site Locations
Total: 5 locations
1
Zai Lab Site 02003
Los Angeles, California, United States, 90007
Actively Recruiting
2
Zai Lab Site 02026
Sarasota, Florida, United States, 34232
Actively Recruiting
3
Zai Lab Site 02005
St Louis, Missouri, United States, 63160
Actively Recruiting
4
Zai Lab Site 02002
New York, New York, United States, 10065
Actively Recruiting
5
Zai Lab Site 02006
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
Z
ZL-6201-001 Study Team
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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