New drug targets Hard-to-Treat cancers with KRAS G12D mutation

NCT ID NCT05382559

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

First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This study tests a new drug called ASP3082 in people with advanced solid tumors that have a specific genetic change called KRAS G12D. The trial has two parts: first, finding a safe dose of ASP3082 alone or with another drug; second, testing it with other cancer treatments. Up to 681 participants will receive the drug through an IV. The main goals are to check safety and find the best dose.

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) and various chemotherapy drugs

What this could lead to

If successful, this could lead to a new treatment option for people with advanced solid tumors that have the KRAS G12D mutation.

What could go wrong

This is an early Phase 1 trial focused on safety, not yet on effectiveness. The drug may not work or could cause side effects. Results may not apply to all patients.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

SOLID TUMOR

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Aichi Cancer Center
RECRUITING

Nagoya, Aichi-ken, Japan
Beijing Cancer Hospital
RECRUITING

Beijing, Beijing Municipality, China
Beth Israel Deaconess Medical Center
RECRUITING

Boston, Massachusetts, 02215, United States
Cancer Institute Hospital of JFCR
RECRUITING

Koto-ku, Tokyo, Japan
Case Western
RECRUITING

Cleveland, Ohio, 44106, United States
City of Hope National Medical Center
RECRUITING

Duarte, California, 91010, United States
Columbia University - Herbert Irving Comprehensive Cancer Center
RECRUITING

New York, New York, 10032, United States
Dana Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Denver HealthONE Drug Development Unit
RECRUITING

Denver, Colorado, 80218, United States
Florida Cancer Specialist
RECRUITING

Lake Mary, Florida, 32746, United States
Florida Cancer Specialists & Research Institute Sarasota
RECRUITING

Sarasota, Florida, 34232-6422, United States
Fudan University Shanghai Cancer Center
RECRUITING

Xuhui District, Shanghai Municipality, China
Georgetown University Hospital
RECRUITING

Washington D.C., District of Columbia, 20007, United States
Hokkaido University Hospital
RECRUITING

Sapporo, Hokkaido, Japan
Kanagawa Cancer Center
RECRUITING

Yokohama, Kanagawa, Japan
Kansai Medical University Hospital
RECRUITING

Hirakata, Osaka, Japan
Kindai University Hospital
RECRUITING

Sayama, Osaka, Japan
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
NEXT Oncology
RECRUITING

San Antonio, Texas, 78229, United States
NEXT Oncology - Virginia Cancer Specialists
RECRUITING

Fairfax, Virginia, 22031, United States
National Cancer Center Hospital
RECRUITING

Chuo-ku, Tokyo, Japan
National Cancer Center Hospital East
RECRUITING

Kashiwa, Chiba, Japan
Niigata Cancer Center Hospital
RECRUITING

Niigata, Niigata, Japan
Oregon Health and Science University
RECRUITING

Portland, Oregon, 97239, United States
Osaka International Cancer Institute
RECRUITING

Osaka, Japan
PanOncology Trials
RECRUITING

San Juan, 00935, Puerto Rico
Roswell Park Cancer Institute
RECRUITING

Buffalo, New York, 14263, United States
SCRI Oncology Partners
TERMINATED

Nashville, Tennessee, 37203, United States
Shikoku Cancer Center
RECRUITING

Matsuyama, Ehime, Japan
Shizuoka Cancer Center
RECRUITING

Sunto-gun, Shizuoka, Japan
Site ES34001
RECRUITING

Barcelona, Spain
Site ES34002
RECRUITING

Málaga, Spain
Site ES34003
RECRUITING

Seville, Spain
Site ES34004
RECRUITING

Madrid, Spain
Site FR33001
RECRUITING

Lyon, France
Site FR33002
RECRUITING

Bordeaux, France
Site FR33003
RECRUITING

La Tronche, Grenobele, France
Site FR33004
RECRUITING

Villejuif, Île-de-France Region, France
Site FR33005
RECRUITING

Lyon, France
Site KR82001
RECRUITING

Jongno -Gu, Seoul, South Korea
Site KR82002
RECRUITING

Seongnam-si, Gyeonggi-do, South Korea
Site KR82003
RECRUITING

Seodaemun-gu, Seoul, South Korea
Site KR82004
RECRUITING

Songpa-gu, Seoul, South Korea
Site KR82005
RECRUITING

Goyang-si, Gyeonggi-do, South Korea
Smilow Cancer Center at Yale New Haven Hospital
RECRUITING

New Haven, Connecticut, 06520-8028, United States
Tohoku University Hospital
RECRUITING

Sendai, Miyagi, Japan
Trinity Health Ann Arbor Hospital
RECRUITING

Ypsilanti, Michigan, 48197, United States
UCLA Santa Monica Hematology Oncology
RECRUITING

Santa Monica, California, 90404, United States
University of Florida, Davis Cancer Center
RECRUITING

Gainesville, Florida, 32610, United States
University of Kansas Medical Center
RECRUITING

Westwood, Kansas, 66205, United States
University of Rochester Medical Center James P. Wilmot Cancer Center
RECRUITING

Rochester, New York, 14642, United States
University of Wisconsin Hospital
RECRUITING

Madison, Wisconsin, 53792, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37232, United States
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States
Yamaguchi University Hospital
RECRUITING

Ube, Yamaguchi, Japan