A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
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).
Pancreatic
Phase III
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
Fluorouracil (5-FU),
Folinic Acid,
Gemcitabine,
INCB161734,
Irinotecan,
Leucovorin,
Nab-Paclitaxel,
Oxaliplatin
Cardin, Dana
International
Vanderbilt University
09-15-2026
Eligibility
18 Years and older
ALL
false
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.
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.
