NCT05495724

Disitamab Vedotin Combined With Tislelizumab for Her2 Overexpressing High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable

An Open Label, Phase 2 Study of Disitamab Vedotin Combined With Tislelizumab for Patients With Her2 Overexpressing (IHC2+ or 3+) High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study to determine the safety and efficacy of Disitamab Vedotin when given in combination with Tislelizumab as treatment for patients with Her2 overexpressing high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not completely resectable. Patients will receive treatment with Disitamab Vedotin in combination with tislelizumab every 3 weeks for 4 treatment cycles over 12 weeks followed by transurethral resection biopsy.

Conditions

• Her2 Overexpressing High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin Tislelizumab	Disitamab Vedotin 120mg will be administered on Day 1 of each cycle for 4 treatment cycles;Tislelizumab 200mg will be administered on Day 2 of each cycle for 4 treatment cycles.
DRUG	Disitamab Vedotin	Disitamab Vedotin

Timeline

• Start date: 2021-07-23
• Primary completion: 2025-02-01
• Completion: 2025-07-01
• First posted: 2022-08-10
• Last updated: 2022-08-10

Locations

1 site across 1 country: China