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RECRUITING
NCT05382559
PHASE1

A Study of ASP3082 in Adults With Advanced Solid Tumors

Sponsor: Astellas Pharma Inc

View on ClinicalTrials.gov

Summary

This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP3082 by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab, to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2. In Part 2, ASP3082 will be given in by itself, or in combination with the other study treatments. Study treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. They will continue treatment until: they have medical problems from the treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.

Official title: A Phase 1 Study of ASP3082 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

681

Start Date

2022-06-08

Completion Date

2028-12-31

Last Updated

2026-04-01

Healthy Volunteers

No

Conditions

Interventions

DRUG

Setidegrasib

Intravenous Infusion

DRUG

Cetuximab

Intravenous Infusion

DRUG

Leucovorin

Intravenous Infusion

DRUG

Oxaliplatin

Intravenous Infusion

DRUG

Fluorouracil

Intravenous Infusion

DRUG

Irinotecan

Intravenous Infusion

DRUG

Nanoparticle albumin-bound-paclitaxel

Intravenous Infusion

DRUG

Gemcitabine

Intravenous Infusion

DRUG

Docetaxel

Intravenous Infusion

DRUG

Pembrolizumab

Intravenous Infusion

DRUG

Cisplatin

Intravenous Infusion

DRUG

Carboplatin

Intravenous Infusion

DRUG

Pemetrexed

Intravenous Infusion

DRUG

Liposomal Irinotecan

Intravenous Infusion

Locations (51)

City of Hope National Medical Center

Duarte, California, United States

UCLA Santa Monica Hematology Oncology

Santa Monica, California, United States

Denver HealthONE Drug Development Unit

Denver, Colorado, United States

Smilow Cancer Center at Yale New Haven Hospital

New Haven, Connecticut, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

University of Florida, Davis Cancer Center

Gainesville, Florida, United States

Florida Cancer Specialist

Lake Mary, Florida, United States

Florida Cancer Specialists & Research Institute Sarasota

Sarasota, Florida, United States

University of Kansas Medical Center

Westwood, Kansas, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Trinity Health Ann Arbor Hospital

Ypsilanti, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Columbia University - Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Case Western

Cleveland, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

NEXT Oncology

San Antonio, Texas, United States

NEXT Oncology - Virginia Cancer Specialists

Fairfax, Virginia, United States

University of Wisconsin Hospital

Madison, Wisconsin, United States

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fudan University Shanghai Cancer Center

Xuhui District, Shanghai Municipality, China

Site FR33003

La Tronche, Grenobele, France

Site FR33002

Bordeaux, France

Site FR33001

Lyon, France

Site FR33005

Lyon, France

Site FR33004

Villejuif, Île-de-France Region, France

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Shikoku Cancer Center

Matsuyama, Ehime, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Kindai University Hospital

Sayama, Osaka, Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Yamaguchi University Hospital

Ube, Yamaguchi, Japan

Osaka International Cancer Institute

Osaka, Japan

PanOncology Trials

San Juan, Puerto Rico

Site KR82002

Seongnam-si, Gyeonggi-do, South Korea

Site KR82001

Jongno -Gu, Seoul, South Korea

Site KR82003

Seodaemun-gu, Seoul, South Korea

Site KR82004

Songpa-gu, Seoul, South Korea

Site ES34001

Barcelona, Spain

Site ES34004

Madrid, Spain

Site ES34002

Málaga, Spain

Site ES34003

Seville, Spain