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Evaluating a new bispecific antibody for advanced lung and other solid tumors

Phase 1/2 Dose Escalation and Expansion Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors

Phase1; Phase2 Interventional Merus N.V. · NCT04868877

This study is testing a new antibody treatment for people with advanced lung cancer and other solid tumors to see if it is safe and effective, both on its own and with other therapies.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment576 (estimated)
Ages18 Years and up
SexAll
SponsorMerus N.V. Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation, prednisone
Locations51 sites (Orange, California and 50 other locations)
Trial IDNCT04868877 on ClinicalTrials.gov

What this trial studies

This phase 1/2 open-label multicenter study aims to evaluate the safety and efficacy of MCLA-129, a bispecific antibody targeting EGFR and c-MET, in patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. The study will begin with a dose escalation phase to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of MCLA-129, both as a monotherapy and in combination with other treatments like Osimertinib and chemotherapy. Eligible patients include those who are treatment-naïve or have progressed after prior therapies for advanced/metastatic disease.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with advanced NSCLC, gastric cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, or other solid tumors who have either failed prior treatments or are treatment-naïve.

Not a fit: Patients with untreated or symptomatic central nervous system metastases or those requiring ongoing steroid therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors, potentially improving outcomes in a challenging patient population.

How similar studies have performed: Other studies evaluating bispecific antibodies targeting similar pathways have shown promise, indicating potential for success in this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Part One: Patients with NSCLC, GC/GEJ, HNSCC, or ESCC who have failed prior standard first-line treatment. Patients must have progressed on or be intolerant to therapies that are known to provide clinical benefit. There is no limit to the number of prior treatment regimens.

Part Two: Patients with NSCLC, HNSCC, other solid tumors and applicable mutations as determined by the investigator.

* Availability of archival or a fresh tumor tissue sample.
* Measurable disease as defined by RECIST version 1.1 by radiologic methods.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy ≥ 12 weeks, as per Investigator.
* Adequate organ function (as per protocol)

Exclusion Criteria:

* Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy (\> 10 mg prednisone or equivalent) to control symptoms within 14 days of study entry.
* Known leptomeningeal involvement.
* Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.
* Systemic anticancer therapy or immunotherapy within 4 weeks or 5 half-lives, whichever is shorter, of the first dose of study drug. For cytotoxic agents that have major delayed toxicity (e.g., mitomycin C, nitrosoureas), a washout period of 6 weeks is required.
* Major surgery or radiotherapy within 3 weeks of the first dose of study drug. Patients who received prior radiotherapy to ≥25% of bone marrow at any time are not eligible.
* Persistent grade \>1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v5.0 and hypothyroidism ≤ grade 2 which is stable on hormone replacement are allowed.
* History of hypersensitivity reaction or any toxicity attributed to human proteins or any of the excipients that warranted permanent cessation of these agents. History of hypersensitivity reaction or any toxicity attributed to chemotherapy and components.
* History of clinically significant cardiovascular disease
* Past medical history of ILD or pneumonitis, or any evidence of clinically active ILD or pneumonitis.
* Previous or concurrent malignancy, excluding non-basal cell carcinomas of skin or carcinoma in situ of the uterine cervix, unless the tumor was treated with curative or palliative intent and in the opinion of the Investigator, with Sponsor agreement, the previous or concurrent malignancy condition does not affect the assessment of safety and efficacy of the study drug.
* Current serious illness or medical conditions including, but not limited to uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
* Active Hepatitis B infection without receiving antiviral treatment.
* Positive test for Hepatitis C
* Known history of HIV (HIV 1/2 antibodies). Patients with HIV with undetectable viral load are allowed. In

Where this trial is running

Orange, California and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Small Cell Lung Cancer MetastaticGastric CancerEsophageal Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaColorectal CancerMCLA-129EGFR inhibitorNSCLC
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.