Spots Global Cancer Trial Database for Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
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Trial Identification
Brief Title: Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
Official Title: Phase I/II, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects With Advanced Solid Malignant Tumors (IDeate-Pantumor01)
Study ID: NCT04145622
Interventions
Study Description
Brief Summary: This study is in one single group of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts. The primary purpose of the parts are: * Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of ifinatamab deruxtecan (I-DXd). * Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd when administered as a single agent. This study is expected to last approximately 5 years from the time the first participant is enrolled to the time the last participant is off the study. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: * they withdraw * their disease gets worse * they experience unacceptable side effects.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States
Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States
Florida Cancer Specialists, Orlando, Florida, United States
Florida Cancer Specialists, Sarasota, Florida, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Washington University, Saint Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
The Ohio State University, Columbus, Ohio, United States
Sidney Kimmel Cancer Center - Thomas Jefferson, Philadelphia, Pennsylvania, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
MDACC (MD Anderson Cancer Center), Houston, Texas, United States
Aichi Cancer Center Hospital, Aichi, , Japan
National Cancer Center Hospital East, Chiba, , Japan
Osaka University Hospital, Osaka, , Japan
Saitama Cancer Center, Saitama, , Japan
Shizuoka Cancer Center Hospital and Research Institute, Shizuoka, , Japan
National Cancer Center Hospital, Tokyo, , Japan
Cancer Institute Hospital of JFCR, Tokyo, , Japan
Showa University Hospital, Tokyo, , Japan
Contact Details
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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