A Study of ASP3082 in Adults With Advanced Solid Tumors
Start Date
6/8/2022
Completion Date
12/31/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Setidegrasib
Cetuximab
Leucovorin
Oxaliplatin
Fluorouracil
Irinotecan
Nanoparticle albumin-bound-paclitaxel
Gemcitabine
Docetaxel
Pembrolizumab
Cisplatin
Carboplatin
Pemetrexed
Liposomal Irinotecan
Conditions
Locations
City of Hope National Medical Center
Duarte, California 91010
United States
UCLA Santa Monica Hematology Oncology
Santa Monica, California 90404
United States
Denver HealthONE Drug Development Unit
Denver, Colorado 80218
United States
Smilow Cancer Center at Yale New Haven Hospital
New Haven, Connecticut 06520-8028
United States
Georgetown University Hospital
Washington D.C., District of Columbia 20007
United States
University of Florida, Davis Cancer Center
Gainesville, Florida 32610
United States
Florida Cancer Specialist
Lake Mary, Florida 32746
United States
Florida Cancer Specialists & Research Institute Sarasota
Sarasota, Florida 34232-6422
United States
University of Kansas Medical Center
Westwood, Kansas 66205
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Trinity Health Ann Arbor Hospital
Ypsilanti, Michigan 48197
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Columbia University - Herbert Irving Comprehensive Cancer Center
New York, New York 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
University of Rochester Medical Center James P. Wilmot Cancer Center
Rochester, New York 14642
United States
Case Western
Cleveland, Ohio 44106
United States
Taylor Cancer Research Center
Maumee, Ohio 43537
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
NEXT Oncology
San Antonio, Texas 78229
United States
NEXT Oncology - Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
University of Wisconsin Hospital
Madison, Wisconsin 53792
United States
Beijing Cancer Hospital
Beijing, Beijing Municipality
China
Fudan University Shanghai Cancer Center
Xuhui District, Shanghai Municipality
China
Shanghai Pulmonary Hospital
Shanghai,
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
Kurume University Hospital
Kurume, Fukuoka
Japan
Hokkaido University Hospital
Sapporo, Hokkaido
Japan
Kanagawa Cancer Center
Yokohama, Kanagawa
Japan
Tohoku University Hospital
Sendai, Miyagi
Japan
Niigata Cancer Center Hospital
Niigata, Niigata
Japan
Kansai Medical University Hospital
Hirakata, Osaka
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, 00935
Puerto Rico
Site KR82005
Goyang-si, Gyeonggi-do
South Korea
Site KR82002
Seongnam-si, Gyeonggi-do
South Korea
Site KR82007
Cheongju-si, North Chungcheong
South Korea
Site KR82001
Jongno -Gu, Seoul
South Korea
Site KR82003
Seodaemun-gu, Seoul
South Korea
Site KR82004
Songpa-gu, Seoul
South Korea
Site KR82006
Seoul,
South Korea
Site ES34011
Pamplona, Navarre
Spain
Site ES34009
A Coruña,
Spain
Site ES34001
Barcelona,
Spain
Site ES34005
Barcelona,
Spain
Site ES34008
Barcelona,
Spain
Site ES34004
Madrid,
Spain
Site ES34006
Madrid,
Spain
Site ES34007
Madrid,
Spain
Site ES34002
Málaga,
Spain
Site ES34003
Seville,
Spain
Site ES34010
Valencia,
Spain