Trials / Active Not Recruiting
Active Not RecruitingNCT04868877
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
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
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 194 (actual)
- Sponsor
- Merus B.V. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 in monotherapy or in combination in patients with NSCLC, HNSCC, GC/GEJ, ESCC, or other solid tumors and who are treatment naïve or have progressed after receiving prior therapy for advanced/metastatic disease.
Conditions
- Non-Small Cell Lung Cancer Metastatic
- Gastric Cancer
- Esophageal Squamous Cell Carcinoma
- Head and Neck Squamous Cell Carcinoma
- Colorectal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MCLA-129 | full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET |
| DRUG | Osimertinib | Approved, 3rd-generation EGFR-TKI |
| DRUG | Chemotherapy | administrated by IV infusion |
Timeline
- Start date
- 2021-04-28
- Primary completion
- 2026-03-01
- Completion
- 2027-03-01
- First posted
- 2021-05-03
- Last updated
- 2026-02-19
Locations
51 sites across 9 countries: United States, Belgium, France, Germany, Italy, Netherlands, Singapore, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04868877. Inclusion in this directory is not an endorsement.