Overview

To Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies

Status:
Not yet recruiting

Trial end date:
2024-08-01

Target enrollment:

Participant gender:

Summary

The goal of this clinical trial is to test in Chinese Subjects with Metastatic or Recurrent Solid Malignancies. The main questions it aims to answer are: - How is the PK of tisotumab vedotin? - How is the immunogenicity of tisotumab vedotin? - How is the safety and tolerability of tisotumab vedotin? - How is the clinical efficacy of tisotumab vedotin? Participants will receive 2.0 mg/kg tisotumab vedotin (up to a maximum of 200 mg in subjects ≥ 100 kg) as a 30-minute IV infusion 1Q3W with the aim to characterize the PK profiles and to evaluate immunogenicity, safety, and tolerability of tisotumab vedotin in the Chinese population. Subjects will receive study treatment until disease progression or any other discontinuation criteria are met, whichever occurs first. Subjects will undergo an end of treatment (EOT) visit 30 days (± 5 days) after the last dose of study treatment or within 7 days after treatment discontinuation has been decided, whichever occurs later.

Phase:

Phase 1

Details

Lead Sponsor:

Zai Lab (Shanghai) Co., Ltd.

Treatments:

Tisotumab vedotin