NCT07374848 · Zai Lab (Shanghai) Co., Ltd.
Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors
What this study is about
The purpose of this study is to evaluate the safety and how well patients handle the treatment of experimental study drug ZL-6201 for treating sarcoma and solid tumors cancer.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Los Angeles, California
- New Haven, Connecticut
- Sarasota, Florida
- St Louis, Missouri
- New York, New York
- Fairfax, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations