BENITIONSClinical Trial Intelligence

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

Phase 1/2 Active, not recruiting NCT06390995

ConditionOvarian Cancer, Solid Tumors
PhasePhase 1/2
SponsorTakeda
StatusActive, not recruiting
Enrollment28 participants
InterventionsTAK-853
Start dateMay 20, 2024
Completion dateApr 16, 2025
Results postedJun 16, 2026

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.

Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cycle 1

Up to Cycle 1 (up to 21 days) · Participants

Phase 1: TAK-853, 6 mg/kg0 Participants

Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

From start of study drug up to 30 days after last dose (up to 3.7 months) · Participants

Phase 1: TAK-853, 6 mg/kg3 Participants

Phase 1: Number of Participants With Grade 3 or Higher TEAEs by Severity

From start of study drug up to 30 days after last dose (up to 3.7 months) · Participants

Phase 1: TAK-853, 6 mg/kg2 Participants

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