Phase III Study of MCLA-129 Antibody for Advanced Non-Small Cell Lung Cancer and Other Solid Tumors Evaluating Safety and Antitumor Effects

What this Trial Is About

Researchers are studying MCLA-129, a human bispecific antibody targeting EGFR and cMet, in patients with advanced solid tumors, including non-small cell lung cancer NSCLC, head and neck cancer, and colorectal cancer. This multi-center, open-label Phase III study aims to evaluate the safety, pharmacokinetics, and antitumor activity of MCLA-129. The study includes patients with tumors that have progressed after standard treatments or are intolerant to them. The study has two parts Part I involves dose escalation and dose expansion to determine safe and effective dose levels of MCLA-129 administered by intravenous infusion every one or two weeks. Part II is a cohort expansion phase assessing efficacy, safety, and pharmacokinetics at the recommended Phase II dose in groups of patients with specific biomarker profiles, such as EGFR mutations or MET amplification. Participants will receive MCLA-129 infusions in 28-day cycles and undergo regular assessments including tumor measurements, safety monitoring, and pharmacokinetic testing. Primary outcomes include dose-limiting toxicity, maximum tolerated dose, overall response rate, and treatment-emergent adverse events. Secondary outcomes measure drug levels, response duration, progression-free survival, and overall survival. Follow-up continues for approximately two years after treatment initiation to monitor effects and safety.

Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors