Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04868877 | 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 | PHASE1 | ACTIVE NOT_RECRUITING | 194 | — | — | Apr 28, 2021 | Mar 1, 2027 | Feb 19, 2026 | 51 | United States, Belgium +7 |
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 ...