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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07403721 | AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors | PHASE1 | RECRUITING | 464 | — | — | Apr 8, 2026 | Jun 28, 2028 | Jun 4, 2026 | 14 | United States, Australia +4 |
| 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...