Title
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)

Description
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)

Objective
Primary: To compare the efficacy of INCB161734 plus chemotherapy versus placebo plus chemotherapy in participants with KRAS G12D mutated PDAC with no prior systemic therapy.

Secondary:
-To further evaluate the efficacy of the combination of INCB161734 plus chemotherapy versus placebo plus chemotherapy in participants with KRAS G12D mutated PDAC with no prior systemic therapy.
-To evaluate the safety and tolerability of the combination of INCB161734 plus chemotherapy versus placebo plus chemotherapy in participants with KRAS G12D mutated PDAC with no prior systemic therapy.
-To evaluate changes in HRQoL in participants with KRAS G12D mutated PDAC with no prior systemic therapy.

Treatment 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).

Key Eligibility 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.

Applicable Disease Sites
Pancreas

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital