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

NCT05866354 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-11-27

No results posted yet for this study

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.

Conditions

  • Solid Malignancies

Interventions

DRUG

Tisotumab Vedotin

Tisotumab vedotin is an antibody-drug conjugate (ADC) targeting tissue factor (TF), a protein aberrantly expressed in a wide number of solid tumors including cervical cancer.

Sponsors & Collaborators

  • Zai Lab (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Rutie Yin, Dr · West China Second University Hospital

  • Guiling Li, Dr · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  • Bingzhong Zhang, Dr · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  • Qing Wen, Dr · Jinan Central Hospital

  • Meili Sun, Dr · Jinan Central Hospital

  • Jianhua Shi, Dr · Linyi Cancer Hospital

  • Dongqing Lv, Dr · Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  • Tienan Yi, Dr · Xiangyang Central Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2023-11-02
Completion
2023-11-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05866354 on ClinicalTrials.gov