Phase I/II First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Advanced Solid Malignant Tumors Multicenter, Two-Part Study (IDeate-PanTumor01)

What this Trial Is About

Researchers are evaluating ifinatamab deruxtecan (I-DXd), a drug given for the first time to humans, in people with advanced solid tumors that have not been cured by other treatments. The study has two parts: the first part aims to find the safest dose and the best dose for further study, while the second part focuses on assessing the drug's safety and its effect on tumors when used alone. This research is expected to last about five years from the first enrollment to the last participant finishing the study. Participants receive I-DXd through an intravenous (IV) infusion every three weeks. In the dose escalation part, participants received increasing doses to find the maximum tolerated dose; this phase is now closed. The dose expansion part currently enrolls participants who receive the recommended dose determined earlier. Treatment cycles continue as long as participants benefit, do not withdraw, do not experience worsening disease, or unacceptable side effects. During the study, participants have regular evaluations including scans to measure tumor size, blood tests, and monitoring for side effects and immune reactions. Researchers track adverse events and study how the drug behaves in the body over several treatment cycles, each lasting 21 days. Safety and tumor response are closely observed until disease progression or after up to eight cycles. Participants may continue treatment beyond eight cycles if benefiting from the drug.

Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors