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

Brief description of study

This is a Phase 1 study testing a new medicine called ZL-6201 (an experimental antibody-drug conjugate - ADC) in patients with advanced bone sarcomas, soft tissue sarcomas, and certain solid tumors, including breast, lung, head and neck, colon, stomach, and pancreatic cancers. These patients have cancers that have spread, cannot be removed with surgery, or have stopped responding to available treatments. ZL-6201 is given through an IV infusion every 3 weeks.

The study has two parts. In Phase 1a, researchers will test increasing doses of ZL-6201 to find the recommended dose (RD) and the maximum tolerated dose (MTD), which is the highest dose that can be given safely. In Phase 1b, additional patients will receive the recommended dose to learn more about the drug's safety and look for signs that it may help treat cancer. Adolescents 12 years of age and older may join the sarcoma expansion group.

The study focuses on patients who have relapsed, refractory, or metastatic cancers and have no standard treatment options left. These cancers were selected because they often have a poor prognosis and an urgent need for new treatments. Researchers are especially interested in these tumors because many of them produce LRRC15, a protein found on tumor cells or in the tissue surrounding tumors, which may be a target of ZL-6201.

Researchers will use a method called the Bayesian Optimal Interval (BOIN) design to guide dose increases or decreases based on side effects seen during the study. This approach helps identify the safest and most effective dose while reducing the risk of serious side effects, known as dose-limiting toxicities (DLTs). The study aims for a DLT rate of about 30%, helping researchers balance safety with finding a dose that may be effective against cancer. The information collected will help determine whether ZL-6201 should move forward into future clinical trials.


Clinical Study Identifier: s26-00052
ClinicalTrials.gov Identifier: NCT07374848
Principal Investigator: Matthew A. Ingham.
Other Investigators: David R. Wise, Yoke Wah Khoo, Kirby Rodriguez, Janice Mehnert, Maya Dimitrova, Elise M Zahriah, Salman Rafi Punekar, Joshua K Sabari, Keriann M Scavone, Rajwanth Veluswamy, Paul E. Oberstein, Eneil De La Pena, Kathleen M Lutz, Jessica Wang, Michelle Diane Swanson Lightfoot, Mariam M Cheaib, Zujun Li, Maria Francis, Elise Roughan, Kristen Spencer, Kathleen M Madden, Nancy Chan, Bhavana Pothuri, Ruth A White, Douglas K Marks.


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