Safety, Tolerability, and Activity Evaluation of Mocertatug Rezetecan Injection in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of Mocertatug Rezetecan in adults with advanced solid tumors, including platinum-resistant ovarian cancer and endometrial cancer. The study aims to observe how levels of Mocertatug Rezetecan change over time at different doses. Participants have tumors that have not responded to or cannot tolerate standard treatments. The study includes two parts dose escalation and dose expansion, both involving administration of Mocertatug Rezetecan as an injection. Participants receive varying doses to determine safety, tolerability, and clinical activity. Tissue samples will be collected for biomarker analysis, including expression of B7-H4. The study may last up to approximately 31 months depending on the part and participant response. Participants will undergo regular assessments including evaluation of tumor response using standard criteria, monitoring of blood and urine tests, vital signs, ECGs, and other laboratory measures. Safety is closely monitored through tracking adverse events and specific toxicity markers. The main outcomes measured include dose limiting toxicities in the first 21 days and objective response rates over about 28 months. Follow-up evaluations continue for safety and clinical activity throughout the study.

A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)