Clinical trial · Interventional
A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)
NCT07522073CI-TRIAL-00120912DAWN-303recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INCB161734 | Drug | — | UNRESOLVED |
| Investigator's choice of chemotherapy | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- INCB161734 plus chemotherapy
- description
- INCB161734 at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.
- interventionNames
- Drug: INCB161734
- Drug: Investigator's choice of chemotherapy
- type
- EXPERIMENTAL
- label
- Placebo plus chemotherapy
- description
- Placebo at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.
- interventionNames
- Drug: Placebo
- Drug: Investigator's choice of chemotherapy
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 current active infection requiring systemic treatment within 1 week prior to the first dose of study drug * Known active CNS metastases Other protocol-defined Inclusion/Exclusion Criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.