Phase 1ab Study of ZL-6201 to Assess Safety, Tolerability, and Early Effectiveness in Adults with Sarcoma and Selected Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of the investigational drug ZL-6201 in adults with sarcoma and certain solid tumors. This open-label, Phase 1ab multicenter trial aims to study how the drug is processed in the body and its initial effectiveness. Participants have advanced or metastatic tumors and meet specific health criteria to join the study. Participants will receive ZL-6201 as a single agent during the study. The treatment is given in cycles lasting 21 days each, with careful monitoring for dose-limiting toxicities and other adverse events throughout the treatment period. The study also collects data on the drugs pharmacokinetics and evaluates tumor responses. During the trial, participants will undergo tumor biopsies or provide archived tissue samples before starting treatment. Researchers will conduct various assessments including laboratory tests, vital sign checks, ECGs, and imaging to measure tumor response and safety over a 36-month period. The study tracks side effects, clinical lab abnormalities, and overall participant health from enrollment through follow-up.

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