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Brief Title: A Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies
Official Title: Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies
Study ID: NCT03913741
Brief Summary: Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects with Advanced Solid Malignancies
Detailed Description: Part 1 of this trial will determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) and the safety profile of tisotumab vedotin in subjects with solid malignancies. Part 2 of this trial will enroll subjects with cervical cancer to provide further data on the safety, tolerability, PK and anti-tumor activity
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
National Cancer Center Hosptial East, Kashiwa-shi, Chiba-Ken, Japan
NHO Shikoku Cancer Center, Matsuyama-Shi, Ehime-Ken, Japan
NHO Hokkaido Cancer Center, Sapporo-shi, Hokkaido, Japan
Kanagawa Cancer Center, Yokohama-shi, Kanagawa-Ken, Japan
Saitama Medical University International Medical Center, Hidaka-shi, Saitama-Ken, Japan
Shizuoka Cancer Center, Sunto-gun, Shizuoka-Ken, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo-To, Japan
Keio University Hospital, Shinjuku-ku, Tokyo-To, Japan
Name: Keiichi Fujiwara, Professor
Affiliation: Saitama Medical University International Medical Center
Role: PRINCIPAL_INVESTIGATOR