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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
Phase 1, PHASE2 trial testing APL-1202 in Non-Muscle Invasive Bladder Cancer (NMIBC) in 6 participants. Completed in 30 June 2020.
30 October 2019
Quick facts
| Lead sponsor | Asieris Pharmaceutical Technologies Co., Ltd. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 30 November 2018 |
| Primary completion | 30 October 2019 |
| Estimated completion | 30 June 2020 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- APL-1202 — full drug profile →
Conditions studied
- Non-Muscle Invasive Bladder Cancer (NMIBC) — all drugs for Non-Muscle Invasive Bladder Cancer (NMIBC) →
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):
-
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 -
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 -
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 -
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:
- PubMed search for NCT03672240
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of APL-1202
Trials testing the same drug.
- NCT06435039 — A Study of APL-1501 Extended Release Capsules Compared to APL-1202 Immediate Release Tablets in Healthy Volunteers · Phase 1 · terminated
- NCT04736394 — A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Ins · Phase 3 · unknown
Other recruiting trials for Non-Muscle Invasive Bladder Cancer (NMIBC)
Currently open trials in the same condition.
- NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03672240 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Asieris Pharmaceutical Technologies Co., Ltd.
- Last refreshed: 20 July 2020
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing