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.

Principal Investigator

Fernand Bteich

For more information about this study, contact:

Fernand Bteich