Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
NCT03526835 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 523 participants |
| Start Date | 2018-05-02 |
| Est. Completion | 2027-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03526835
The ClinicalTrials.gov registry entry for NCT03526835 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 523 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merus B.V., which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03526835 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Texas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03526835?
This trial is sponsored by Merus B.V., which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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