A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)

Incyte

Status and phase: Enrolling; Phase 3

Conditions: Solid Tumors

Treatments: Drug: Investigator's choice of chemotherapy; Drug: Placebo; Drug: INCB161734

Study type: Interventional

Funder types: Industry

Identifiers

NCT07522073

INCB161734-303

Details and patient eligibility

About

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).

Enrollment: 588 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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588 participants in 2 patient groups

INCB161734 plus chemotherapy

Experimental group

Description:

INCB161734 at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.

Treatment:

Drug: INCB161734

Drug: Investigator's choice of chemotherapy

Placebo plus chemotherapy

Experimental group

Description:

Placebo at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.

Treatment:

Drug: Investigator's choice of chemotherapy

Drug: Placebo