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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

NCT07522073

RecruitingPhase 3

Sponsor: Incyte Corporation

Conditions: Solid Tumors

Interventions: INCB161734, Placebo, Investigator's choice of chemotherapy

Countries: United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (219)
  • Birmingham, Alabama, United States
  • Anchorage, Alaska, United States
  • Chandler, Arizona, United States
  • Tucson, Arizona, United States
  • Duarte, California, United States
  • Fullerton, California, United States
  • La Jolla, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • San Francisco, California, United States
  • Santa Monica, California, United States
  • Denver, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Washington D.C., District of Columbia, United States
  • Fort Myers, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • St. Petersburg, Florida, United States
  • West Palm Beach, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Evanston, Illinois, United States
  • Naperville, Illinois, United States
  • Springfield, Illinois, United States
  • Indianapolis, Indiana, United States
  • New Orleans, Louisiana, United States
  • Boston, Massachusetts, United States
  • + 189 more on CT.gov