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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06818812 | A Study to Evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation | PHASE1 | ACTIVE NOT_RECRUITING | 30 | — | — | Mar 27, 2025 | Mar 27, 2027 | Mar 23, 2026 | 9 | United States |
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Defined as adverse events reported for the first time or worsening of a pre-existing event occurring after the first dose of study drug up to 30 days (for INCB186748 as monotherapy and in combination with GEMNabP or mFOLFIRINOX) and 60 days (for INCB186748 in combination with cetuximab) after the last dose of INCB186748.
Number of participants with TEAEs leading to dose modification or discontinuation.
| Arm | Type | Description |
|---|---|---|
| Part 1a: Dose Escalation monotherapy | EXPERIMENTAL | INCB186748 at the protocol-defined dose strength based on cohort assignment. |
| Part 1b: Dose Expansion monotherapy | EXPERIMENTAL | INCB186748 at the protocol-defined dose strength based on cohort assignment. |
| Part 1c: Pharmacodynamic cohort | EXPERIMENTAL | INCB186748 at the protocol-defined dose strength based on cohort assignment. |
| Part 1d: Food-Effect | EXPERIMENTAL | Evaluate food effect on drug exposure as defined in the protocol. |
| Part 2a: Dose Escalation combination | EXPERIMENTAL | INCB186748 in combination at the protocol-defined dose strength based on cohort assignment. |
| Part 2b: Dose Expansion combination | EXPERIMENTAL | INCB186748 in combination at the protocol-defined dose strength based on cohort assignment. |
| Name | Type | Description |
|---|---|---|
| INCB186748 | DRUG | INCB186748 will be administered at protocol defined dose. |
| Cetuximab | DRUG | Cetuximab will be administered at protocol defined dose. |
| GEMNabP | DRUG | GEMNabP will be administered at protocol defined dose. |
| mFOLFIRINOX | DRUG | mFOLFIRINOX will be administered at protocol defined dose. |
Inclusion Criteria: * ≥18 years old. * Locally advanced or metastatic solid tumor with KRAS G12D mutation. * For Part 1 and Part 2 Combination Group 1: Disease progression on or after prior standard treatment, or intolerance to or ineligibility for standard treatment, or no standard available treat...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |