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Also known as bispecific
MCLA-129 · 1 trial · 5 indications
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single-agent MCLA-129 as well as in combination with chemotherapy in patients with NSCLC, GC/GEJ adenocarcinoma, HNSCC or ESCC, with disease progression after prior therapy for advanced/metastatic disease.
To evaluate the ORR of MCLA-129 monotherapy or in combination with an EGFR TKI or chemotherapy in molecularly defined populations of advanced/metastatic solid tumors.
| Arm | Type | Description |
|---|---|---|
| Part 2 NSCLC Second-line or more harboring EGFR exon 20 Insertion | EXPERIMENTAL | Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D). |
| Part 2 NSCLC Second-line or more harboring cMet exon 14 skipping mutation | EXPERIMENTAL | Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D). |
| Part 2 Selected solid tumors with or without an EGFR or cMet alteration | EXPERIMENTAL | Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D). |
| Part 2 NSCLC First-line harboring EGFR sensitizing mutations | EXPERIMENTAL | Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg. |
| Part 2 NSCLC Second-line or more, osimertinib resistant (combo with osimertinib) | EXPERIMENTAL | Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg. |
| Part 2 NSCLC Second-line or more, osimertinib resistant (combo with chemotherapy) | EXPERIMENTAL | Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and chemotherapy every three weeks per standard of care according to local guidance. |
| Part 2 NSCLC Third-line or more, osimertinib resistant, platinum resistant (combo with chemotherapy) | EXPERIMENTAL | Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and chemotherapy every three weeks per standard of care according to local guidance. |
| Name | Type | Description |
|---|---|---|
| MCLA-129 | DRUG | full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET |
| Osimertinib | DRUG | Approved, 3rd-generation EGFR-TKI |
| Chemotherapy | DRUG | administrated by IV infusion |
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 ...
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MCLA-129 is an investigational bispecific antibody being studied for the treatment of metastatic non-small cell lung cancer (NSCLC). It is also being evaluated in other solid tumors, including gastric cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, and colorectal cancer. The drug is currently in Phase 1 clinical development.
MCLA-129 targets EGFR, the epidermal growth factor receptor. It is designed as a bispecific antibody that also targets c-MET, as indicated by its description as a human anti-EGFR, anti-c-MET bispecific antibody. This dual targeting approach is being investigated for its potential in treating certain solid tumors.
MCLA-129 is being developed by Merus N.V., a biopharmaceutical company. Merus is publicly traded on the Nasdaq under the ticker symbol MRUS. The company is conducting clinical trials to evaluate the safety and efficacy of MCLA-129 in patients with advanced solid tumors.
MCLA-129 is currently in Phase 1 clinical development. The drug is being studied in a Phase 1/2 trial, but it is not yet approved by regulatory authorities. It remains an investigational agent, and its safety and effectiveness have not been fully established.
MCLA-129 is being evaluated in clinical trial NCT04868877, a Phase 1/2 study in advanced NSCLC and other solid tumors, both alone and in combination. The trial is active but not recruiting, with an enrollment of 194 participants across multiple countries, including the United States, Belgium, France, and others.
Yes, MCLA-129 is a bispecific antibody, specifically a human anti-EGFR, anti-c-MET bispecific antibody. This means it is designed to bind to two different targets, EGFR and c-MET, which are involved in tumor growth. This dual-targeting mechanism is being studied for its potential therapeutic benefit.