drugset
drugset / Trial / NCT04813107

A Study to Evaluate the Safety and Efficacy of Oral APL-1202 in Combination With Tislelizumab Compared to Tislelizumab Alone as Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer

NCT04813107 ↗

Phase 1/2 Unknown 79 enrolled Jiangsu Yahong Meditech Co., Ltd aka Asieris
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is designed to evaluate the safety, efficacy, and biomarker response of APL-1202 in combination with tislelizumab as neoadjuvant therapy for patients with MIBC who are cisplatin ineligible or refuse cisplatin-based chemotherapy.

Timeline

Start
2021-12-28
Primary completion
2023-11-01
Completion
2024-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator APL-1202 Unknown 125 mg Oral
Comparator APL-1202 Unknown 250 mg Oral
Comparator APL-1202 Unknown 375 mg Oral
Comparator Tislelizumab Monoclonal antibody 200 mg Intravenous

Indications

urinary bladder carcinoma