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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)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
November 3, 2019
Primary Completion Date
April 30, 2027
Completion Date
October 31, 2029
Last Updated
January 28, 2026
250
ESTIMATED participants
Ifinatamab deruxtecan (I-DXd)
DRUG
(Japan sites) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
+81-3-6225-1111(M-F 9-5 JST)dsclinicaltrial@daiichisankyo.co.jp(US sites) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
908-992-6400CTRinfo_us@daiichisankyo.comLead Sponsor
Daiichi Sankyo
Collaborators
NCT05720117
NCT06898450
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06658951