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Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
Sponsor: Daiichi Sankyo
Summary
This is a single group study 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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2019-11-03
Completion Date
2029-10-31
Last Updated
2026-01-28
Healthy Volunteers
No
Interventions
Ifinatamab deruxtecan (I-DXd)
A total anti-B7H3 antibody and MAAA-1181a
Locations (25)
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
St 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
Hokkaido University Hospital
Hokkaido, Japan
Osaka University Hospital
Osaka, Japan
Kindai University Hospital
Ōsaka-sayama, 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