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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
A total anti-B7H3 antibody and MAAA-1181a
Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
WITHDRAWNSarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
RECRUITINGFlorida Cancer Specialists
Orlando, Florida, United States
WITHDRAWNFlorida Cancer Specialists
Sarasota, Florida, United States
Evaluate the incidence of dose-limiting toxicities (DLTs)
Time frame: Day 1 to Day 21 in Cycle 1 in the dose escalation part
Evaluate the incidence of adverse events (AEs)
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Investigate the antitumor activity of ifinatamab deruxtecan (I-DXd)
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Characterize the PK parameter AUClast
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Characterize the PK parameter AUCtau
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Characterize the PK parameter Cmax
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Characterize the PK parameter Tmax
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Characterize the PK parameter Ctrough
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Assess the incidence of anti-drug antibodies (ADAs)
Time frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
(Japan sites) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
(US sites) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
ACTIVE_NOT_RECRUITINGHenry Ford Hospital
Detroit, Michigan, United States
ACTIVE_NOT_RECRUITINGWashington University
St Louis, Missouri, United States
ACTIVE_NOT_RECRUITINGJohn Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
RECRUITINGColumbia University Medical Center
New York, New York, United States
WITHDRAWNMemorial Sloan-Kettering Cancer Center
New York, New York, United States
ACTIVE_NOT_RECRUITING...and 18 more locations