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Study identifier: NCT03526835 Synced from ClinicalTrials.gov · August 02, 2026
● Recruiting

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

Condition: Advanced/Metastatic Solid Tumors · Colorectal Cancer · Gastric Cancer  ·  Sponsor: Merus B.V.

PhasePhase 1/Phase 2
Planned participants560
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Silke Thiele, MD  ·  +31 85 016 2500  ·  enquiries-merus@genmab.com

Eduardo Pennella, MD  ·  +1 617 401 4499  ·  USenquiries-merus@genmab.com

Always discuss trial participation with your own doctor first.

Locations (54)

UCSDLa Jolla, California, United StatesRecruiting
USC Norris Comprehensive Cancer CenterLos Angeles, California, United StatesActive Not Recruiting
Sharp HealthcareSan Diego, California, United StatesRecruiting
Rocky Mountain Cancer CentersLone Tree, Colorado, United StatesRecruiting
Florida Cancer SpecialistsFort Myers, Florida, United StatesActive Not Recruiting
University of FloridaGainesville, Florida, United StatesRecruiting
Sarah Cannon Research Institute (Lake Nona)Orlando, Florida, United StatesRecruiting
Emory UniversityAtlanta, Georgia, United StatesRecruiting
Massachusetts General Hospital - Dana FarberBoston, Massachusetts, United StatesRecruiting
Karmanos Cancer InstituteDetroit, Michigan, United StatesCompleted
SSM Health Saint Louis University HospitalSt Louis, Missouri, United StatesCompleted
Washington University School of Medicine at St LouisSt Louis, Missouri, United StatesRecruiting

+ 42 more locations — full list on the registry record.

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