RecruitingPhase 1NCT07374848

Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors

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


Sponsor

Zai Lab (Shanghai) Co., Ltd.

Enrollment

180 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing the safety, dosing, and early effectiveness of ZL-6201, a new experimental drug, in adults with advanced sarcoma (a type of cancer affecting bone or soft tissues) or other selected solid tumors that have not responded to prior treatments. **You may be eligible if...** - You are 18 or older with an ECOG performance score of 0 or 1 (good physical function) - You have been diagnosed with advanced unresectable or metastatic sarcoma, or a selected solid tumor - You are willing to provide a tumor biopsy or archived tumor tissue sample - For sarcoma: you have received no more than 2 prior lines of treatment for metastatic disease - For other solid tumors: you have received no more than 3 prior lines of treatment - You have at least one measurable tumor lesion and adequate organ function - You test negative for HIV, hepatitis B, and hepatitis C **You may NOT be eligible if...** - You have another active cancer requiring treatment within the past 2 years - You have brain metastases causing symptoms or requiring steroids - You have previously been treated with a topoisomerase-1 inhibitor antibody-drug conjugate (ADC) - You have significant heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZL-6201

ZL-6201 as a single-agent


Locations(2)

Zai Lab Site 02026

Sarasota, Florida, United States

Zai Lab Site 02006

Fairfax, Virginia, United States

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NCT07374848


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