4 not yet recruiting, 3 completed, 2 recruiting, 1 active not recruiting. 11 Phase 1, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Not yet recruiting 4, Completed 3, Recruiting 2, Active not recruiting 1, Terminated 1 |
| Phase 2 | 6 | Not yet recruiting 4, Completed 1, Recruiting 1 |
Follow NMIBC: new trials by email Literature Review of NMIBC trials Research Report on NMIBC
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Trop2-Targeted Near-Infrared Fluorescence Imaging-Guided Precise Resection of Non-Muscle Invasive Bladder Cancer TTP-ICG NIR fluorescent diagnostic agent - NMIBC | Phase 1 / Phase 2 | Not yet recruiting | Yunnan Cancer Hospital | 30 | 2026-10-30 | 2026-09-24 |
| A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC UGN-501 - Bladder (Urothelial, Transitional Cell) Cancer, NMIBC | Phase 1 | Recruiting | UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd. | 30 | 2026-09-28 | 2026-10-13 |
| The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG. SPGL008 - NMIBC | Phase 1 / Phase 2 | Not yet recruiting | Shenyang Sunshine Pharmaceutical Co., LTD. | 120 | 2026-03-12 | 2026-03-03 |
| ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG Intravesical Recombinant Mycobacterium (rMBCG) - NMIBC | Phase 1 / Phase 2 | Recruiting | ImmunityBio, Inc. | 40 | 2025-10-15 | 2026-03-27 |
| A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC. Gemcitabine + BCG, BCG (TICE strain) - NMIBC, Non-Muscle Invasive Bladder Urothelial Carcinoma | Phase 1 / Phase 2 | Not yet recruiting | Queen's University | 31 | 2025-08-01 | 2025-07-17 |
| SHR-1501 Combined With SHR-2005 for High-Risk Non-Muscle Invasive Bladder Cancer Which is Not Completely Resectable by TURBt SHR-1501+SHR-2005 - NMIBC | Phase 1 / Phase 2 | Not yet recruiting | Fudan University | 58 | 2024-10-01 | 2024-09-19 |
| A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer ZH9 - NMIBC, High Risk NMIBC | Phase 1 | Completed | Prokarium Ltd | 22 | 2024-01-08 | 2026-10-14 |
| A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer AU-011, AU-011 in Combination with Medical Laser Adminstration, AU-011 in Combination with Medical Laser Administration - Non-muscle-invasive Bladder Cancer, NMIBC | Phase 1 | Active not recruiting | Aura Biosciences | 55 | 2022-09-26 | 2026-08-06 |
| A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC) UGN-301, UGN-201, Gemcitabine - Non-muscle Invasive Bladder Cancer, NMIBC | Phase 1 | Completed | UroGen Pharma Ltd. | 51 | 2022-06-01 | 2026-01-14 |
| A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC) Enfortumab vedotin - Urinary Bladder Neoplasms, Carcinoma in Situ | Phase 1 | Terminated | Astellas Pharma Global Development, Inc. | 37 | 2021-12-07 | 2026-09-14 |
| A Phase I-II Study of Novel Oncolytic Virus VG161 Via Intravesical Instillation for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer VG161 via Intravesical Instillation - NMIBC | Phase 1 / Phase 2 | Completed | Ding-Wei Ye | 20 | 2021-10-12 | 2026-04-01 |
Non-Muscle Invasive Bladder Neoplasms (11) · Urinary Bladder Neoplasms (4) · Neoplasms (2) · Carcinoma in Situ (1) · Carcinoma, Transitional Cell (1)
Carcinoma (11) · Female Urogenital Diseases (11) · Female Urogenital Diseases and Pregnancy Complications (11) · Male Urogenital Diseases (11) · Neoplasms by Histologic Type (11) · Neoplasms by Site (11) · Neoplasms, Glandular and Epithelial (11) · Urinary Bladder Diseases (11) · Urogenital Diseases (11) · Urogenital Neoplasms (11) · Urologic Diseases (11) · Urologic Neoplasms (11) · Neoplasms (9) · Urinary Bladder Neoplasms (7)
Gemcitabine (2) · BCG Vaccine (1) · Imiquimod (1) · enfortumab vedotin (1)
Astellas Pharma Global Development, Inc. (1) · Aura Biosciences (1) · Ding-Wei Ye (1) · Fudan University (1) · ImmunityBio, Inc. (1) · Prokarium Ltd (1) · Queen's University (1) · Shenyang Sunshine Pharmaceutical Co., LTD. (1) · UroGen Pharma Ltd. (1) · UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd. (1) · Yunnan Cancer Hospital (1)
United States (6) · China (3) · Canada (2) · Spain (2) · Australia (1) · France (1) · Germany (1) · Italy (1) · United Kingdom (1)
Sebastian Mirkin, MD (2) · Dingwei Ye, MD (1) · Josefin-Beate Holz, MD (1)
2023 (1)