Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This is an open-label, phase 1, PK trial of intravenous tisotumab vedotin in Chinese subjects with recurrent or metastatic solid tumors who have failed on previous standard systemic therapy. The screening period will be up to 28 days, after which eligible subjects 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. Blood samples for the assessment of tisotumab vedotin concentrations and antidrug antibody (ADA) will be drawn in accordance with the PK and ADA collection schedule. Three different PK analytes will be measured: 1) tisotumab vedotin (conjugated antibody only), 2) total antibody (ie, conjugated and unconjugated antibody), and 3) free MMAE. PK parameters to be estimated will include, but are not limited to, AUC, Cmax, time to maximum concentration (Tmax), apparent terminal half-life (t1/2), and trough concentration (Ctrough). Safety and tolerability will be evaluated based on TEAEs, clinical safety assessments and clinical laboratory assessments. Ocular AEs are a known safety risk of tisotumab vedotin treatment. Therefore, the eye care plan will be implemented for all subjects enrolled in this trial. Efficacy assessments will include confirmed ORR assessed by the investigator, primarily based on the enhanced computed tomography (CT) or magnetic resonance imaging (MRI) scans performed at protocol-specified time points. The RECIST v1.1 criteria will be used for response evaluation. After discontinuation of study treatment, tumor assessments may or may not be performed at the discretion of the investigator. At the end of study (EOS), sponsor will ensure provision of continued tisotumab vedotin to subjects with clinical benefit defined as stable disease (SD) or better, until criteria of treatment discontinuation are met. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05866354
Study type Interventional
Source Zai Lab (Hong Kong), Ltd.
Contact
Status Completed
Phase Phase 1
Start date June 16, 2023
Completion date November 2, 2023

See also
  Status Clinical Trial Phase
Completed NCT01202370 - A Phase I Study of AR-67 (7-t-butyldimethylsilyl-10-hydroxycamptothecin) Given on Days 1, 4 8, 12 & 15 of an Every 21-day Cycle in Adult Patients With Refractory or Metastatic Solid Malignancies Phase 1
Completed NCT00162136 - Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies. Phase 1
Recruiting NCT05006794 - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies Phase 1
Active, not recruiting NCT02537418 - Durvalumab With or Without Tremelimumab in Advanced Incurable Solid Malignancies Given With or Without Standard Chemotherapy Regimens Phase 1
Completed NCT01540526 - Pharmacodynamic Study With FLT-PET/CT in Patients With Prostate/Other Solid Malignancies Treated With High Dose Axitinib Phase 1
Completed NCT00033202 - This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Solid Tumor Phase 1
Recruiting NCT04492735 - The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid Malignancies
Completed NCT02640755 - Absorption, Metabolism, Excretion and Pharmacokinetics of a Single Dose [14C]AZD2014 Followed by a Multiple Dose Phase Phase 1
Terminated NCT00695370 - Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children Phase 2
Completed NCT02325739 - FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression Phase 1/Phase 2
Completed NCT00676299 - A Safety and Dose-finding Study of JNJ-26483327, a Drug in Development for Cancer, for Patients With Advanced and/or Refractory Solid Malignancies. Phase 1
Active, not recruiting NCT00090727 - Chemotherapy for Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma Phase 1
Terminated NCT01112397 - Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours Phase 1
Not yet recruiting NCT00751894 - Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5) Phase 2