A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients

Phase 3 Unknown 800 enrolled Jiangsu Yahong Meditech Co., Ltd aka Asieris

RandomizedParallel-groupOpen-labelTreatment

Summary

A multi-center, randomized, open-label, parallel-controlled Phase Ⅲ clinical trial to evaluate the clinical safety and efficacy of APL-1202 as a single-agent oral treatment versus intravesical instillation of Epirubicin hydrochloride in naïve intermediate-risk non-muscle invasive bladder cancer (NMIBC) patients

Timeline

Start: 2021-09-29
Primary completion: 2025-03-01
Completion: 2025-12-31

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	APL-1202	Unknown	—	Oral
Comparator	Epirubicin	Small molecule	—	Intravenous

A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients

Summary

Timeline

Drugs

Indications