Trials / Recruiting
RecruitingNCT07522073
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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 588 (estimated)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INCB161734 | Oral; tablet |
| DRUG | Placebo | Oral; tablet |
| DRUG | Investigator's choice of chemotherapy | The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol: |
Timeline
- Start date
- 2026-04-09
- Primary completion
- 2028-09-15
- Completion
- 2029-03-19
- First posted
- 2026-04-13
- Last updated
- 2026-04-13
Locations
212 sites across 20 countries: United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07522073. Inclusion in this directory is not an endorsement.