Clinical Trials Study
Phase 3
A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
Conditions: SOLID TUMORS
- Study #:
- NCT07522073
- Last Updated:
- 10/08/2026
- Recruitment Status:
- Recruiting
- Estimated Study Completion Date:
- 03/19/2029
Summary
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).
Age: 18 Years and older
Gender: All
Start Date: 04/09/2026
Primary Completion Date (Estimated): 09/15/2028
Study Completion Date (Estimated): 03/19/2029
Accepts Healthy Volunteers: No
Trial Purpose and Description
Eligibility Criteria
Age: 18 Years and older
Gender: All
Accepts Healthy Volunteers: No
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.