A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
Key facts
- Where
- Akashi, HYGO, Fukuoka Fukuoka, Kahoku-gun, Kitaadachi-gun, Kōtoku, Mitaka-shi, Osaka, Sapporo Hokkaido, Shinjuku-ku, Suita, Osaka, Toyama, Wakayama, and Yokohama, JapanSee the 13 sites
- Phase
- Phase 3
Where in Japan
- Akashi, HYGOAkashi, HYGO, JapanNo longer taking part
- Fukuoka FukuokaFukuoka Fukuoka, JapanNot yet recruiting
- Kahoku-gunKahoku-gun, JapanTaking people
- Kitaadachi-gunKitaadachi-gun, JapanNot yet recruiting
- KōtokuKōtoku, JapanTaking people
- Mitaka-shiMitaka-shi, JapanTaking people
- OsakaOsaka, JapanTaking people
- Sapporo HokkaidoSapporo Hokkaido, JapanNot yet recruiting
- Shinjuku-kuShinjuku-ku, JapanTaking people
- Suita, OsakaSuita, Osaka, JapanNot yet recruiting
- ToyamaToyama, JapanTaking people
- WakayamaWakayama, JapanTaking people
- YokohamaYokohama, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Incyte Corporation
- Trial code
- NCT07522073
- Record updated
- 30 October 2026
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: 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: 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.