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

Recruiting · NCT07522073 · Interventional (participants receive a specific treatment) · Lead sponsor: Incyte Corporation

View the official record on ClinicalTrials.gov →

Pancreatic cancer

Interventions studied

INCB161734Investigator's choice of chemotherapyPlacebo

What this trial is about

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).

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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
ther protocol-defined Inclusion/Exclusion Criteria may apply.

Where it is running

60 locations listed across 30 US states.

Investigative Site US058 - Birmingham, Alabama, United States
Investigative Site US016 - Anchorage, Alaska, United States
Investigative Site US026 - Chandler, Arizona, United States
Investigative Site US045 - Tucson, Arizona, United States
Investigative Site US051 - Duarte, California, United States
Investigative Site US085 - Fullerton, California, United States
Investigative Site US054 - La Jolla, California, United States
Investigative Site US086 - Long Beach, California, United States
Investigative Site US027 - Los Angeles, California, United States
Investigative Site US036 - Los Angeles, California, United States
Investigative Site US048 - Los Angeles, California, United States
Investigative Site US049 - Orange, California, United States
Investigative Site US034 - San Francisco, California, United States
Investigative Site US001 - Santa Monica, California, United States
Investigative Site US071 - Denver, Colorado, United States
Investigative Site US013 - Washington D.C., District of Columbia, United States
Investigative Site US046 - Washington D.C., District of Columbia, United States
Investigative Site US072 - Fort Myers, Florida, United States
Investigative Site US083 - Jacksonville, Florida, United States
Investigative Site US075 - Miami, Florida, United States
Investigative Site US074 - St. Petersburg, Florida, United States
Investigative Site US073 - West Palm Beach, Florida, United States
Investigative Site US023 - Atlanta, Georgia, United States
Investigative Site US079 - Chicago, Illinois, United States
Investigative Site US030 - Evanston, Illinois, United States
Investigative Site US005 - Naperville, Illinois, United States
Investigative Site US009 - Springfield, Illinois, United States
Investigative Site US021 - Indianapolis, Indiana, United States
Investigative Site US007 - New Orleans, Louisiana, United States
Investigative Site US022 - Boston, Massachusetts, United States
Investigative Site US006 - Ann Arbor, Michigan, United States
Investigative Site US010 - Detroit, Michigan, United States
Investigative Site US078 - Grand Rapids, Michigan, United States
Investigative Site US012 - Ypsilanti, Michigan, United States
Investigative Site US066 - Maple Grove, Minnesota, United States
Investigative Site US047 - Hattiesburg, Mississippi, United States
Investigative Site US084 - Reno, Nevada, United States
Investigative Site US077 - Hackensack, New Jersey, United States
Investigative Site US017 - Morristown, New Jersey, United States
Investigative Site US059 - Lake Success, New York, United States
Investigative Site US031 - New York, New York, United States
Investigative Site US041 - New York, New York, United States
Investigative Site US003 - New York, New York, United States
Investigative Site US029 - The Bronx, New York, United States
Investigative Site US035 - Chapel Hill, North Carolina, United States
Investigative Site US050 - Cleveland, Ohio, United States
Investigative Site US020 - Cleveland, Ohio, United States
Investigative Site US033 - Columbus, Ohio, United States
Investigative Site US042 - Portland, Oregon, United States
Investigative Site US008 - Philadelphia, Pennsylvania, United States
Investigative Site US043 - Philadelphia, Pennsylvania, United States
Investigative Site US056 - Pittsburgh, Pennsylvania, United States
Investigative Site US082 - Charleston, South Carolina, United States
Investigative Site US055 - Sioux Falls, South Dakota, United States
Investigative Site US039 - Nashville, Tennessee, United States
Investigative Site US060 - Nashville, Tennessee, United States
Investigative Site US070 - Nashville, Tennessee, United States
Investigative Site US067 - Dallas, Texas, United States
Investigative Site US062 - Denison, Texas, United States
Investigative Site US011 - Houston, Texas, United States

Showing 60 of 219 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →