NCT03672240

Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment

A Phase Ib Study of APL-1202 in NMIBC Patients Who Are Resistant to One Induction Course of BCG Treatment

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Asieris Pharmaceutical Technologies Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

A Phase Ib, open label, non randomized study to measure the safety and PK characteristics of APL-1202 at steady-state in adult male and female BCG resistant NMIBC patients when it is administered alone and concurrently with BCG.

Detailed description

Six eligible participants will be administered with APL-1202 one week prior to the first BCG instillation, during the six-week course of BCG instillation, and additional five weeks, for a total of 12 weeks of dosing. Safety assessment will be performed during the entire 13 week study duration. Plasma and urine samples will be collected from each participant at prior to first and fifth BCG instillations for PK analysis.

Conditions

• Non-Muscle Invasive Bladder Cancer (NMIBC)

Interventions

Type	Name	Description
DRUG	APL-1202	To assess the safety and pharmacokinetics of APL-1202 alone and in combination with Bacillus Calmette Guerin

Timeline

• Start date: 2018-11-30
• Primary completion: 2019-10-30
• Completion: 2020-06-30
• First posted: 2018-09-14
• Last updated: 2020-07-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study