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ACTIVE NOT RECRUITING
NCT06390995
PHASE1/PHASE2

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

Sponsor: Takeda

View on ClinicalTrials.gov

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.

Official title: A Phase 1/2 Open-label Study to Evaluate The Safety, Tolerability, Efficacy And Pharmacokinetics of Mirvetuximab Soravtansine (TAK-853) in Japanese Patients With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2024-05-20

Completion Date

2027-03-19

Last Updated

2025-06-15

Healthy Volunteers

No

Interventions

DRUG

TAK-853

TAK-853 intravenous injection

Locations (20)

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

Jikei University Kashiwa Hospital

Kashiwa, Chiba, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Shikoku Cancer Center

Matsuyama, Ehime, Japan

Kurume University Hospital

Kurume, Fukuoka, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Hyogo Cancer Center

Akashi, Hyōgo, Japan

Iwate Medical University Hospital

Shiwa-gun, Iwate, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Shizuoka Cancer Center

Nakatogari, Shizuoka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

The Jikei University Hospital

Minato-ku, Tokyo, Japan

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Chiba University Hospital

Chiba, Japan

Kyoto University Hospital

Kyoto, Japan

Okayama University Hospital

Okayama, Japan

Osaka International Cancer Institute

Osaka, Japan