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NCT03526835 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Colorectal Cancer and Gastric Cancer, sponsored by Merus B.V..

Recruiting
Registry status
Phase 1
Development phase
523
Enrollment target
20
Study locations

NCT03526835: Recruiting Phase 1 study of Colorectal Cancer and Gastric Cancer, sponsored by Merus B.V..

NCT03526835 is a Phase 1 study of Colorectal Cancer and Gastric Cancer that is actively recruiting participants, run by Merus B.V.. The registered enrollment target is 523 participants, below the 1,543-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03526835, a Phase 1 study of Colorectal Cancer and Gastric Cancer, is actively recruiting participants, sponsored by Merus B.V..

RECRUITING
Registry status
Phase 1
Development phase
523 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Evaluation of the number and severity of participants with treatment related toxicities observed during the dose escalation.

Conditions Studied

Colorectal Cancer Gastric Cancer Esophageal Cancer Head and Neck Squamous Cell Carcinoma NSCLC HNSCC Gastroesophageal-junction Cancer Advanced/Metastatic Solid Tumors

Interventions

  • DRUG MCLA-158
  • COMBINATION_PRODUCT MCLA-158 + Pembrolizumab
  • COMBINATION_PRODUCT MCLA-158 + FOLFIRI
  • COMBINATION_PRODUCT MCLA-158 + FOLFOX

Study Locations (20)

California

  • UCSD - La Jolla
  • USC Norris Comprehensive Cancer Center - Los Angeles
  • Sharp Healthcare - San Diego

Texas

  • Texas Oncology - Dallas
  • Oncology Consultants - Houston
  • Texas Oncology - Tyler

Florida

  • Florida Cancer Specialists - Fort Myers
  • Sarah Cannon Research Institute (Lake Nona) - Orlando

Missouri

  • SSM Health Saint Louis University Hospital - St Louis
  • Washington University School of Medicine at St Louis - St Louis

New York

  • Cayuga Medical Center - Ithaca
  • Hematology-Oncology Associates of Central New York - Syracuse

Ohio

  • Cleveland Clinic - Cleveland
  • Taylor Cancer Research Center - Maumee

Tennessee

  • The University Of Tennessee Health Science Center - Memphis
  • Sarah Cannon Research Institute - Nashville

Colorado

  • Rocky Mountain Cancer Centers - Lone Tree

Trial Details

FieldValue
Enrollment Target 523 participants
Start Date 2018-05-02
Est. Completion 2027-11
Phase Phase 1
Merus B.V.

8 total trials

What NCT03526835 shows while recruiting

NCT03526835 is an interventional study that assigns participants to a tested intervention. The registered 523 participants enrollment target is mid-sized for trials with a published cap, below the 1,543-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (66% lower).

The record links to 8 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 4 interventions - of which MCLA-158 is the first listed.

NCT03526835 names 20 study sites across 11 states, led by California, Texas, Florida.

Frequently Asked Questions

What is clinical trial NCT03526835 about?

NCT03526835 is a clinical study titled "A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors". 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 expansio...

What is the current status of trial NCT03526835?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 523 participants. The study started on 2018-05-02. Estimated completion is 2027-11.

What conditions does trial NCT03526835 study?

This clinical trial studies the following conditions: Colorectal Cancer, Gastric Cancer, Esophageal Cancer, Head and Neck Squamous Cell Carcinoma, NSCLC.

What interventions are being tested in trial NCT03526835?

The interventions under investigation include: MCLA-158 (DRUG), MCLA-158 + Pembrolizumab (COMBINATION_PRODUCT), MCLA-158 + FOLFIRI (COMBINATION_PRODUCT), MCLA-158 + FOLFOX (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT03526835?

This trial is sponsored by Merus B.V., which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03526835 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Colorectal Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03526835's enrollment target sits among peer trials

523 78th of 381 higher than 304 of 381 other Colorectal Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT03526835

Source: ClinicalTrials.gov NCT03526835, the US trial registry maintained by the National Library of Medicine. NCT03526835 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.