Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCB161734 · 3 trials · 2 indications
Defined as the time from the date of randomization to the date of death due to any cause.
Defined as the time from the date of randomization to the date of the first documented progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause.
Defined as complete response (CR) or partial response (PR) as determined by BICR per RECIST v1.1.
Defined as maximum observed plasma or serum concentration of INCB161734.
Defined as the area under the concentration-time curve up to the last measurable concentration of INCB161734.
Defined as the area under the concentration-time curve from 0 to infinity of INCB161734.
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 after first dose of study drug monotherapy and in combination with cetuximab and retifanlimab.
Number of participants with TEAEs leading to dose modification or discontinuation.
| Arm | Type | Description |
|---|---|---|
| INCB161734 plus chemotherapy | EXPERIMENTAL | INCB161734 at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements. |
| Placebo plus chemotherapy | EXPERIMENTAL | Placebo at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements. |
| Cohort 1 | EXPERIMENTAL | INCB161734 and itraconazole will be administered at protocol defined doses. |
| Cohort 2 | EXPERIMENTAL | INCB161734 and rifampin will be administered at protocol defined doses. |
| Cohort 3 | EXPERIMENTAL | INCB161734 and esomeprazole will be administered at protocol defined doses. |
| Cohort 4 | EXPERIMENTAL | INCB161734 and famotidine will be administered at protocol defined doses. |
| Part 1a: Dose Escalation monotherapy | EXPERIMENTAL | INCB161734 at the protocol-defined dose strength based on cohort assignment. |
| Part 1b: Dose Expansion monotherapy | EXPERIMENTAL | INCB161734 at the protocol-defined dose strength based on cohort assignment. |
| Part 1c: Pharmacodynamic cohort | EXPERIMENTAL | INCB161734 at the protocol-defined dose strength based on cohort assignment. |
| Part 2a: Dose Escalation combination | EXPERIMENTAL | INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. |
| Part 2b: Dose Expansion combination | EXPERIMENTAL | INCB161734 in combination 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. |
| Name | Type | Description |
|---|---|---|
| INCB161734 | DRUG | Oral; tablet |
| Placebo | DRUG | Oral; tablet |
| Investigator's choice of chemotherapy | DRUG | The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol: |
| Itraconazole | DRUG | Oral; Tablet |
| Rifampin | DRUG | Oral; Tablet |
| Esomeprazole | DRUG | Oral; Tablet |
| Famotidine | DRUG | Oral; Tablet |
| Cetuximab | DRUG | Cetuximab will be administered at protocol defined dose. |
| Retifanlimab | DRUG | Retifanlimab 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. |
| FOLFOX | DRUG | FOLFOX will be administered at protocol defined dose. |
| FOLFIRI | DRUG | FOLFIRI will be administered at protocol defined dose. |
| INCA33890 | DRUG | INCA33890 will be administered at protocol defined dose. |
Inclusion Criteria: * Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation * No prior systemic treatment in the metastatic setting * ECOG Performance status 0-1 * Adequate organ function Exclusion Criteria: * Prior treatment with any KRAS inhibitor * Chronic or curr...
| 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 |
INCB161734 is an investigational small molecule being studied for the treatment of solid tumors with the KRAS G12D mutation, including advanced or metastatic solid tumors and previously untreated metastatic pancreatic ductal adenocarcinoma. It is also being studied in healthy participants to assess its pharmacokinetics.
INCB161734 targets KRAS G12D, a specific mutation in the KRAS gene. This mutation is associated with certain solid tumors, and the drug is designed to act on this molecular target.
INCB161734 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY.
INCB161734 is in Phase 1 clinical development. It is being evaluated in early-stage trials for solid tumors and healthy participants. It is not yet approved by the FDA and remains investigational.
INCB161734 is being studied in three clinical trials. NCT06179160 is a Phase 1 study in advanced or metastatic solid tumors with KRAS G12D mutation. NCT07018635 is a completed Phase 1 study in healthy participants. NCT07522073 is a Phase 3 study in previously untreated KRAS G12D-mutated metastatic pancreatic ductal adenocarcinoma.
No alternative names for INCB161734 have been disclosed. It is referred to solely by its code name INCB161734 in clinical trial registries and by its developer, Incyte Corporation.