Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and in Combination
- Conditions
- Non-Small Cell Lung Cancer MetastaticGastric CancerEsophageal Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaColorectal Cancer
- Registration Number
- NCT04868877
- Lead Sponsor
- Merus N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 576
Part One: Patients with NSCLC, GC/GEJ, HNSCC, or ESCC who have failed prior standard<br>first-line treatment. Patients must have progressed on or be intolerant to therapies that<br>are known to provide clinical benefit. There is no limit to the number of prior treatment<br>regimens.<br><br>Part Two: Patients with NSCLC, HNSCC, other solid tumors and applicable mutations as<br>determined by the investigator.<br><br> - Availability of archival or a fresh tumor tissue sample.<br><br> - Measurable disease as defined by RECIST version 1.1 by radiologic methods.<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.<br><br> - Life expectancy = 12 weeks, as per Investigator.<br><br> - Adequate organ function (as per protocol)<br><br>Exclusion Criteria:<br><br> - Central nervous system metastases that are untreated or symptomatic, or require<br> radiation, surgery, or continued steroid therapy (> 10 mg prednisone or equivalent)<br> to control symptoms within 14 days of study entry.<br><br> - Known leptomeningeal involvement.<br><br> - Participation in another clinical study or treatment with any investigational drug<br> within 4 weeks prior to study entry.<br><br> - Systemic anticancer therapy or immunotherapy within 4 weeks or 5 half-lives,<br> whichever is shorter, of the first dose of study drug. For cytotoxic agents that<br> have major delayed toxicity (e.g., mitomycin C, nitrosoureas), a washout period of 6<br> weeks is required.<br><br> - Major surgery or radiotherapy within 3 weeks of the first dose of study drug.<br> Patients who received prior radiotherapy to =25% of bone marrow at any time are not<br> eligible.<br><br> - Persistent grade >1 clinically significant toxicities related to prior<br> antineoplastic therapies (except for alopecia); stable sensory neuropathy = grade 2<br> NCI-CTCAE v5.0 and hypothyroidism = grade 2 which is stable on hormone replacement<br> are allowed.<br><br> - History of hypersensitivity reaction or any toxicity attributed to human proteins or<br> any of the excipients that warranted permanent cessation of these agents. History of<br> hypersensitivity reaction or any toxicity attributed to chemotherapy and components.<br><br> - History of clinically significant cardiovascular disease<br><br> - Past medical history of ILD or pneumonitis, or any evidence of clinically active ILD<br> or pneumonitis.<br><br> - Previous or concurrent malignancy, excluding non-basal cell carcinomas of skin or<br> carcinoma in situ of the uterine cervix, unless the tumor was treated with curative<br> or palliative intent and in the opinion of the Investigator, with Sponsor agreement,<br> the previous or concurrent malignancy condition does not affect the assessment of<br> safety and efficacy of the study drug.<br><br> - Current serious illness or medical conditions including, but not limited to<br> uncontrolled active infection, clinically significant pulmonary, metabolic or<br> psychiatric disorders<br><br> - Active Hepatitis B infection without receiving antiviral treatment.<br><br> - Positive test for Hepatitis C<br><br> - Known history of HIV (HIV 1/2 antibodies). Patients with HIV with undetectable viral<br> load are allowed. In
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D);To evaluate clinical activity, as assessed by ORR
- Secondary Outcome Measures
Name Time Method To evaluate preliminary antitumor activity in terms of BOR;To evaluate preliminary antitumor activity in terms of DCR;To evaluate preliminary antitumor activity in terms of DoR;To evaluate progression-free survival (PFS);To evaluate overall survival (OS);Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy;Proportion of patient with treatment discontinuations of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy.;AE, regardless of relationship to study treatment;All safety endpoints