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

NCT03672240 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-07-20

No results posted yet for this study

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.

Conditions

  • Non-Muscle Invasive Bladder Cancer (NMIBC)

Interventions

DRUG

APL-1202

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

Sponsors & Collaborators

  • Asieris Pharmaceutical Technologies Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Harish Dave, MD · Linical Accelovance

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2019-10-30
Completion
2020-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03672240 on ClinicalTrials.gov