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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07522073 | A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma | PHASE3 | RECRUITING | 588 | — | — | Apr 9, 2026 | Mar 19, 2029 | Jun 1, 2026 | 215 | United States, Australia +18 |
| NCT06179160 | A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation | PHASE1 | RECRUITING | 710 | — | — | Jan 4, 2024 | Jan 1, 2027 | May 4, 2026 | 37 | United States, Australia +6 |
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.
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. |
| 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: |
| 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, 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 |