drugset / Trial / NCT06390995

A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors

NCT06390995

Phase 1/2 Active not recruiting 28 enrolled Takeda
NaSingle-groupOpen-labelTreatment

Summary

The main aim of this study are to check for side effects from TAK-853, check how much TAK-853 participants can receive without getting side effects from it, check how well TAK-853 controls symptoms, and to check how much TAK-853 stays in their blood over time. The study will be conducted in two phases including Phase 1 Part and Phase 2 Part. In Phase 1 Part, the participants will stay in the hospital for 3 days at least after their 1st injection for some tests and to check for any side effects from their treatment. In Phase 2 Part, participants will visit their study hospital for multiple times. In both phases, the participants will receive TAK-853 on the first days of each 3-week cycle. The participant will be in the study for about 9 months in Phase 1 Part and for about 24 months in Phase 2 Part. The study doctors will check for side effects from the study treatments.

Timeline

Start
2024-05-20
Primary completion
2025-04-16
Completion
2027-03-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Mirvetuximab Soravtansine Other / unclassified 6 mg/kg Intravenous

Indications