Phase 12 Study of MCLA-158 Alone or Combined With Other Treatments for Advanced Solid Tumors Including Metastatic Colorectal Cancer and Head and Neck Cancer

What this Trial Is About

Researchers are evaluating MCLA-158, a bispecific antibody targeting EGFR and LGR5, in patients with advanced solid tumors, including metastatic colorectal cancer mCRC and head and neck squamous cell carcinoma HNSCC. This Phase 12 open-label study aims to determine the recommended Phase II dose RP2D and assess the safety, tolerability, pharmacokinetics, immunogenicity, and anti-tumor activity of MCLA-158 alone or combined with other therapies. The dose escalation phase has been completed, and expansion cohorts are ongoing for selected tumors with EGFR dependency. Participants receive MCLA-158 either as a single agent or in combination with pembrolizumab or chemotherapy regimens FOLFIRI or FOLFOX. The single-agent dose is administered intravenously every two weeks in 28-day cycles. The study includes various cohorts, some closed and others actively enrolling, evaluating different doses and formulations, including a subcutaneous version. Combination therapies are explored mainly in mCRC and HNSCC patients at different treatment lines. During the study, participants undergo regular assessments including safety monitoring, laboratory tests, cardiac evaluations, and tumor response measurements over periods ranging from weeks to months. Researchers track dose-limiting toxicities, adverse events, pharmacokinetic markers, and anti-tumor efficacy using standardized criteria. Follow-up extends up to 36 months to observe long-term outcomes, treatment discontinuations, and antibody responses, ensuring comprehensive evaluation of MCLA-158s profile.

A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors