Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
Start Date
11/3/2019
Completion Date
10/31/2029
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Ifinatamab deruxtecan (I-DXd)
Conditions
Locations
Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California 90048
United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218
United States
Florida Cancer Specialists
Orlando, Florida 32804
United States
Florida Cancer Specialists
Sarasota, Florida 34232
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02115
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Washington University
St Louis, Missouri 63110
United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Columbia University Medical Center
New York, New York 10032
United States
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United States
The Ohio State University
Columbus, Ohio 43210
United States
Sidney Kimmel Cancer Center - Thomas Jefferson
Philadelphia, Pennsylvania 19107
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Tennessee Oncology
Nashville, Tennessee 37203
United States
MDACC (MD Anderson Cancer Center)
Houston, Texas 77030
United States
Aichi Cancer Center Hospital
Aichi, 464-8681
Japan
National Cancer Center Hospital East
Chiba, 277-8577
Japan
Hokkaido University Hospital
Hokkaido, 060-8648
Japan
Kobe City Medical Center General Hospital
Hyōgo, 650-0047
Japan
Kagawa University Hospital
Kagawa, 761-0793
Japan
The University of Osaka Hospital
Osaka, 565-0871
Japan
Kindai University Hospital
Ōsaka-sayama, 589-8511
Japan
Saitama Cancer Center
Saitama, 362-0806
Japan
Shizuoka Cancer Center
Shizuoka, 411-8777
Japan
National Cancer Center Hospital
Tokyo, 104-0045
Japan
Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Japan
Showa Medical University Hospital
Tokyo, 142-8666
Japan
Keio University Hospital
Tokyo, 160-8582
Japan