New drug targets genetic weakness in tough pancreatic cancer

NCT ID NCT07409272

Recruiting now Disease control Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether adding setidegrasib (ASP3082) to standard chemotherapy helps people with a specific KRAS G12D mutation in metastatic pancreatic cancer live longer. About 614 adults will be randomly assigned to receive either setidegrasib or a placebo, along with chemotherapy. The study aims to see if the combination delays cancer growth and improves survival.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: setidegrasib (ASP3082)
What this could lead to: If it works, this could lead to a new targeted treatment option for people with a specific genetic mutation in pancreatic cancer, potentially extending life when combined with chemotherapy.
What could go wrong: This is a large phase 3 trial, but the drug is still experimental. It may not improve survival or could cause side effects. The benefit depends on the specific KRAS G12D mutation, which not all patients have.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic adenocarcinoma pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

METASTATIC PANCREATIC ADENOCARCINOMA METASTATIC PANCREATIC CANCER PANCREATIC CANCER

Contacts and locations

Locations

AGH Singer Research Institute
RECRUITING

Pittsburgh, Pennsylvania, 15212, United States
Allina Health Cancer Institute - Hematology Cancer Care Services
RECRUITING

Minneapolis, Minnesota, 55407, United States
Atlantic Health - Overlook Medical Center
RECRUITING

Morristown, New Jersey, 07962, United States
Baptist Health Medical Group Oncology
RECRUITING

Miami, Florida, 33176, United States
Baptist MD Anderson Cancer Institute
RECRUITING

Jacksonville, Florida, 32207, United States
Brown University Health Cancer Institute - Division of Hematology/Oncology
RECRUITING

Providence, Rhode Island, 02906, United States
Cedars-Sinai - Cedars-Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Chugoku-Shikoku Group - Shikoku Cancer Center
RECRUITING

Matsuyama, Ehime, Japan
Crosson Cancer Institute at Providence St. Jude Medical Center in Fullerton
RECRUITING

Fullerton, California, 92835, United States
Dartmouth Hitchcock Medical Center
RECRUITING

Lebanon, New Hampshire, 03756, United States
Facilities Design and Construction - Energy Advancement and Innovation Center
RECRUITING

Columbus, Ohio, 43210, United States
Fred Hutchinson Cancer Center - Advanced Cancer Research Group
RECRUITING

Seattle, Washington, 98109, United States
Hartford Healthcare
RECRUITING

Hartford, Connecticut, 06016, United States
HealthPartners Cancer Center at Regions Hospital
RECRUITING

Saint Paul, Minnesota, 55101, United States
HealthPartners Frauenshuh Cancer Center
RECRUITING

Saint Louis Park, Minnesota, 55426, United States
Hoag Mem Hosp Presbyterian
RECRUITING

Newport Beach, California, 92663, United States
Houston Methodist Office of Graduate - Houston Methodist Neal Cancer Center at Texas Medical Center
RECRUITING

Houston, Texas, 77030, United States
Indiana University Health - Indiana University Melvin and Bren Simon Comprehensive Cancer Center
RECRUITING

Indianapolis, Indiana, 46202, United States
Inova Schar Cancer Institute Clinical Trials
RECRUITING

Fairfax, Virginia, 22031, United States
Japanese Foundation for Cancer Research - The Cancer Institute Hospital of JFCR
RECRUITING

Koto, Tokyo, Japan
Kyushu Group - Kyushu Cancer Center
RECRUITING

Fukuoka, Fukuoka, Japan
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING

New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center - Main Campus
RECRUITING

New York, New York, 10065, United States
Mercy CH Chub O'Reilly Cancer Center
RECRUITING

Springfield, Missouri, 65804, United States
Mercy Cancer Center
RECRUITING

Fort Smith, Arkansas, 72903, United States
Mercy David C. Pratt Cancer Center - St. - Mercy Research - David C. Pratt Cancer Center
RECRUITING

St Louis, Missouri, 63141, United States
Mercy Hospital Oklahoma City - Mercy Coletta Cancer Center - Oklahoma City
RECRUITING

Oklahoma City, Oklahoma, 73120, United States
Mount Sinai Medical Center - Miami Beach
RECRUITING

Miami Beach, Florida, 33140, United States
NYU Long Island Mineola
RECRUITING

Mineola, New York, 11501, United States
Nara Medical University Hospital
RECRUITING

Kashihara-shi, Nara, Japan
National Cancer Center Hospital East
RECRUITING

Kashiwa, Chiba, Japan
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
RECRUITING

Osaka, Japan
Saint Elizabeth Medical Center, Inc. DBA St. Elizabeth Health Care
RECRUITING

Edgewood, Kentucky, 41017, United States
Saint Joseph Hospital - Cancer Centers - St. Vincent Frontier Cancer Center
RECRUITING

Billings, Montana, 59102, United States
The Alvin J. Siteman Cancer Center - Center for Advanced Med
RECRUITING

St Louis, Missouri, 63110, United States
The University of Osaka Hospital
RECRUITING

Suita, Osaka, Japan
The University of Tokyo Hospital
RECRUITING

Bunkyo-ku, Tokyo, Japan
UT Southwestern Medical Center at Dallas
RECRUITING

Dallas, Texas, 75390, United States
UVA Emily Couric Cancer Center
RECRUITING

Charlottesville, Virginia, 22903, United States
University of Arizona Cancer Center - North Campus
RECRUITING

Tucson, Arizona, 85719, United States
University of Maryland School - Division of Hematology/Oncology
RECRUITING

Baltimore, Maryland, 21201, United States
University of Michigan Health - University of Michigan Medical Center
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Rochester
RECRUITING

Rochester, New York, 14611, United States
Utah Cancer Specialists
RECRUITING

Salt Lake City, Utah, 84106, United States
Virginia Cancer Specialists
RECRUITING

Fairfax, Virginia, 22031, United States
Virginia Mason Franciscan Health - Virginia Mason Medical Center
RECRUITING

Seattle, Washington, 98101, United States
White Plains Hospital Center for Cancer Care - Oncology
RECRUITING

White Plains, New York, 10601, United States
Yamaguchi University Hospital
RECRUITING

Ube-shi, Yamaguchi, Japan

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