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A Study of ASP3082 in Adults With Advanced Solid Tumors
Sponsor: Astellas Pharma Inc
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
Setidegrasib
Intravenous Infusion
Cetuximab
Intravenous Infusion
Leucovorin
Intravenous Infusion
Oxaliplatin
Intravenous Infusion
Fluorouracil
Intravenous Infusion
Irinotecan
Intravenous Infusion
Nanoparticle albumin-bound-paclitaxel
Intravenous Infusion
Gemcitabine
Intravenous Infusion
Docetaxel
Intravenous Infusion
Pembrolizumab
Intravenous Infusion
Cisplatin
Intravenous Infusion
Carboplatin
Intravenous Infusion
Pemetrexed
Intravenous Infusion
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