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 (Protocol No.: INCB161734-303)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2030260075

Enrollment

Registered

2026-04-22

Start date

2026-05-08

Completion date

Unknown

Last updated

2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PDAC (pancreatic ductal adenocarcinoma)

Interventions

Experimental: INCB161734 plus chemotherapy INCB161734 at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requireme

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation 2. No prior systemic treatment in the metastatic setting 3. ECOG Performance status 0-1 4. Adequate organ function

Exclusion criteria

Exclusion criteria: 1. Prior treatment with any KRAS inhibitor 2. Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug 3. Known active CNS metastases Other protocol-defined Inclusion/Exclusion Criteria may apply.

Design outcomes

Primary

Measure	Time frame
1. Overall Survival (OS) [Time Frame: Up to approximately 3 years] 2. Progression-free survival (PFS) by BICR [Time Frame: Up to approximately 2 years] 3. Objective Response by BICR [Time Frame: Up to approximately 2 years]	—

Secondary

Measure	Time frame
1. Duration of Response (DOR) by BICR [Time Frame: Up to approximately 2 years] 2. Disease control by BICR [Time Frame: Up to approximately 2 years] 3. Progression-Free Survival (PFS) by investigator assessment [Time Frame: Up to approximately 2 years] 4. Objective response by investigator assessment [Time Frame: Up to approximately 2 years] 5. DOR by investigator assessment [Time Frame: Up to approximately 2 years] 6. Disease control by investigator assessment [Time Frame: Up to approximately 2 years] 7. Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to approximately 2 years and 30 days] 8. TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment [Time Frame: Up to approximately 2 years and 30 days] 9. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit [Time Frame: Up to approximately 2 years] 10. Change from baseline in EORTC QLQ-PAN26 score at each postbaseline visit [Time Frame: Up to approximately 2 years] 11. Change from baseline in EQ-5D-5L score at each postbaseline visit [Time Frame: Up to approximately 2 years]	—

Measure

Time frame

1. Duration of Response (DOR) by BICR [Time Frame: Up to approximately 2 years] 2. Disease control by BICR [Time Frame: Up to approximately 2 years] 3. Progression-Free Survival (PFS) by investigator assessment [Time Frame: Up to approximately 2 years] 4. Objective response by investigator assessment [Time Frame: Up to approximately 2 years] 5. DOR by investigator assessment [Time Frame: Up to approximately 2 years] 6. Disease control by investigator assessment [Time Frame: Up to approximately 2 years] 7. Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to approximately 2 years and 30 days] 8. TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment [Time Frame: Up to approximately 2 years and 30 days] 9. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit [Time Frame: Up to approximately 2 years] 10. Change from baseline in EORTC QLQ-PAN26 score at each postbaseline visit [Time Frame: Up to approximately 2 years] 11. Change from baseline in EQ-5D-5L score at each postbaseline visit [Time Frame: Up to approximately 2 years]

—

Countries

Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

Public ContactMedical Information Center

Incyte Biosciences Japan G.K.

jpmedinfo@incyte.com+81-120-094-139

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: May 30, 2026