Clinical Trial

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

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC. The dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer (mCRC). The study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies.
Protocol Amendment History 4 changes
critical Primary endpoint(s) modified 2026-07-30
notable Trial sites expanded: 45 -> 54 locations 2026-07-30
notable Primary completion pushed: 2025-11 -> 2028-05 2026-07-30
minor Completion pushed: 2027-11 -> 2028-11 2026-07-30
Trial Details
NCT Number NCT03526835
Lead Sponsor Merus B.V.
Conditions Advanced/Metastatic Solid Tumors, Colorectal Cancer, Gastric Cancer, Gastroesophageal-junction Cancer, NSCLC, HNSCC, Head and Neck Squamous Cell Carcinoma, Esophageal Cancer
Enrollment 560 participants
Start Date 2018-05-02
Primary Completion 2028-05 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-29