Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCB186748 · 1 trial · 1 indication
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 |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
INCB186748 is an investigational small molecule being developed by Incyte Corporation for the treatment of advanced or metastatic solid tumors that carry a KRAS G12D mutation. It is currently in Phase 1 clinical development and has not been approved by the FDA.
INCB186748 targets tumors with the KRAS G12D mutation. It is being studied in patients with advanced or metastatic solid tumors that harbor this specific genetic alteration, as part of a targeted oncology approach.
INcyte Corporation (NASDAQ: INCY) is developing INCB186748. The company is conducting a Phase 1 clinical trial of the drug in the United States for patients with advanced or metastatic solid tumors.
INCB186748 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being evaluated for safety and efficacy in clinical trials.
INCB186748 is being studied in a Phase 1 trial with the identifier NCT06818812. This active but not recruiting study is evaluating the drug in approximately 30 adult participants with advanced or metastatic solid tumors that have a KRAS G12D mutation.