A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Solid Tumors

In brief

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).

Key facts

Study ID

NCT07522073

Run by

Incyte Corporation

People needed

588

Starts

2026-04-09

Expected to finish

2029-03-19

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Investigative Site US059 — Lake Success, New York, United States (enrolling)
• Investigative Site US067 — Dallas, Texas, United States (enrolling)
• Investigative Site US078 — Grand Rapids, Michigan, United States (enrolling)
• Investigative Site US017 — Morristown, New Jersey, United States (enrolling)
• Investigative Site US043 — Philadelphia, Pennsylvania, United States (enrolling)
• Investigative Site US060 — Nashville, Tennessee, United States (enrolling)
• Investigative Site US009 — Springfield, Illinois, United States (enrolling)
• Investigative Site US022 — Boston, Massachusetts, United States (enrolling)
• Investigative Site US066 — Maple Grove, Minnesota, United States (enrolling)
• Investigative Site US077 — Hackensack, New Jersey, United States (enrolling)
• Investigative Site US020 — Cleveland, Ohio, United States (enrolling)
• Investigative Site US008 — Philadelphia, Pennsylvania, United States (enrolling)
• Investigative Site US055 — Sioux Falls, South Dakota, United States (enrolling)
• Investigative Site US071 — Denver, Colorado, United States (enrolling)
• Investigative Site US016 — Anchorage, Alaska, United States (enrolling)
• Investigative Site US005 — Naperville, Illinois, United States (enrolling)
• Investigative Site US072 — Fort Myers, Florida, United States (enrolling)
• Investigative Site US027 — Los Angeles, California, United States (enrolling)
• Investigative Site US036 — Los Angeles, California, United States (enrolling)
• Investigative Site US074 — St. Petersburg, Florida, United States (enrolling)
• Investigative Site US073 — West Palm Beach, Florida, United States (enrolling)
• Investigative Site US048 — Los Angeles, California, United States (enrolling)
• Investigative Site US003 — New York, New York, United States (enrolling)
• Investigative Site US029 — The Bronx, New York, United States (enrolling)
• Investigative Site US062 — Denison, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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