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NCT03672240: NMIBC

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

Completed Phase 1, PHASE2 Last updated 20 July 2020
What this trial tests

Phase 1, PHASE2 trial testing APL-1202 in Non-Muscle Invasive Bladder Cancer (NMIBC) in 6 participants. Completed in 30 June 2020.

Timeline
30 November 2018
Primary endpoint
30 October 2019
30 June 2020

Quick facts

Lead sponsorAsieris Pharmaceutical Technologies Co., Ltd.
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date30 November 2018
Primary completion30 October 2019
Estimated completion30 June 2020
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Asieris Pharmaceutical Technologies Co., Ltd.

Who can join

Adults 18 to 99, any sex, with Non-Muscle Invasive Bladder Cancer (NMIBC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Amino acid metabolism in health and disease.
    Ling ZN, Jiang YF, Ru JN, Lu JH, et al · · 2023 · cited 291× · PMID 37699892 · DOI 10.1038/s41392-023-01569-3
  2. Elucidation of Novel Molecular Targets for Therapeutic Strategies in Urothelial Carcinoma: A Literature Review.
    Nelson BE, Hong A, Jana B. · · 2021 · cited 8× · PMID 34422659 · DOI 10.3389/fonc.2021.705294
  3. Emerging bladder-sparing treatments for high risk non-muscle invasive bladder cancer.
    Gurbani CM, Chong YL, Choo ZW, Chia D, et al · · 2025 · cited 1× · PMID 40584211 · DOI 10.1177/23523735251348842
  4. Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacillus Calmette-Guérin failure: a systematic review.
    Soma T, Takemura K, Toide M, Ito M, et al · · 2026 · PMID 41635525 · DOI 10.1136/bmjonc-2025-000753

Verify or expand the search:

Other trials of APL-1202

Trials testing the same drug.

Other recruiting trials for Non-Muscle Invasive Bladder Cancer (NMIBC)

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03672240.

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