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AMG 436 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1A | EXPERIMENTAL | AMG 436 monotherapy dose escalation. |
| Part 1B: Food Effect Substudy | EXPERIMENTAL | Participants will receive AMG 436 under fasted and fed conditions (United States only). |
| Part 2 | EXPERIMENTAL | AMG 436 + combination dose escalation. |
| Part 3 | EXPERIMENTAL | AMG 436 monotherapy Dose expansion and optimization. |
| Part 4 | EXPERIMENTAL | AMG 436 + chemotherapy combination dose expansions. |
| Name | Type | Description |
|---|---|---|
| AMG 436 | DRUG | AMG 436 will be administered. |
Inclusion Criteria: * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years). * Histologically confirmed MSI-H or dMMR metastatic or locally advanced solid tumor by local testing or central testing. * Tumor tissue (formalin-fixed, paraffin-embedded sample) archival block mu...
AMG 436 is an investigational therapy being studied in adults with metastatic or locally advanced solid tumors that have microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR). It is being evaluated as both monotherapy and combination therapy in this biomarker-selected cancer population.
AMG 436 is being developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen is the sponsor of the clinical program evaluating the drug in MSI-H and dMMR solid tumors.
AMG 436 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program is currently recruiting participants and is designed to evaluate the drug in patients with MSI-H or dMMR advanced solid tumors.
AMG 436 is being studied in the Phase 1 trial NCT07403721, titled AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors. The trial is recruiting, has an enrollment target of 464 participants, and is running in the United States, Australia, Belgium, Canada, China, France, Japan, South Korea, Spain, and Taiwan.
Yes. AMG 436 is being studied specifically in patients whose tumors have microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR), making it a biomarker-selected program. The Phase 1 trial NCT07403721 enrolls adults 18 years and older with these biomarker-defined metastatic or locally advanced solid tumors.