NCT03913741

A Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies

Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	tisotumab vedotin	Tisotumab vedotin will be administered intravenously once every 21 days. The dose levels will be determined by the starting dose and the escalation steps taken in the trial

Timeline

• Start date: 2019-02-27
• Primary completion: 2020-08-14
• Completion: 2021-10-30
• First posted: 2019-04-12
• Last updated: 2022-06-23

Locations

8 sites across 1 country: Japan