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)
ENROLLING
Trial ID:
NCT07522073 Protocol # :
26-273
Conditions
Solid Tumors
Phase
III
Disease Sites
Pancreas
Principal Investigator
Huffman, Brandon
Site Research Nurses
Giannandrea, Gianna
Graham, Christopher
Lawson, Susan
Sawin, Mark
Vanasse, Katherine
Trial 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).
Eligibility Requirements
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.
26-273