OncoMatch/Clinical Trials/NCT04145622
Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
Is NCT04145622 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Ifinatamab deruxtecan (I-DXd) for advanced solid tumor.
Treatment: Ifinatamab deruxtecan (I-DXd) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: B7-H3 targeted agent (ifinatamab deruxtecan, DS-7300a, I-DXd)
prior treatment with B7-H3 targeted agent, including I-DXd
Cannot have received: antibody drug conjugate (ADC) with exatecan derivative (trastuzumab deruxtecan)
Exception: only if discontinued due to treatment-related toxicities
prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., trastuzumab deruxtecan) due to treatment-related toxicities
Lab requirements
Blood counts
adequate hematopoietic function
Kidney function
adequate renal function
Liver function
adequate hepatic function
Cardiac function
adequate cardiac function
Has adequate cardiac, hematopoietic, renal and hepatic functions
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute · Los Angeles, California
- Sarah Cannon Research Institute at HealthONE · Denver, Colorado
- Florida Cancer Specialists · Orlando, Florida
- Florida Cancer Specialists · Sarasota, Florida
- Dana Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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