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NCT04738630
Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Status unknown
Phase 2
Last updated 4 February 2021
What this trial tests
Phase 2 trial testing HX008 in Bladder Cancer in 110 participants. Status unknown.
Timeline
25 September 2020
Primary endpoint
1 December 2022
1 December 2022
1 December 2023
Quick facts
| Lead sponsor | Taizhou Hanzhong biomedical co. LTD |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 110 |
| Start date | 25 September 2020 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 December 2023 |
| Sites | 5 locations across China |
Drugs / interventions tested
- HX008 — full drug profile →
Conditions studied
- Bladder Cancer — all drugs for Bladder Cancer →
Sponsor
Taizhou Hanzhong biomedical co. LTD — full company profile →
Who can join
18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-arm, multicenter study to evaluate the efficacy and safety of HX008 injection in patients with BCG-unresponsive non-muscle invasive bladder cancer.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
New Perspectives in the Medical Treatment of Non-Muscle-Invasive Bladder Cancer: Immune Checkpoint Inhibitors and Beyond.
Audisio A, Buttigliero C, Delcuratolo MD, Parlagreco E, et al · · 2022 · cited 28× · PMID 35159167 · DOI 10.3390/cells11030357 -
Novel immunotherapeutic options for BCG-unresponsive high-risk non-muscle-invasive bladder cancer.
Hannouneh ZA, Hijazi A, Alsaleem AA, Hami S, et al · · 2023 · cited 26× · PMID 38037752 · DOI 10.1002/cam4.6768 -
Pharmacologic Therapies for Non-Muscle Invasive Bladder Cancer: Current and Future Treatments.
Goldberg IP, Lichtbroun B, Singer EA, Ghodoussipour S. · · 2022 · cited 13× · PMID 36051251 · DOI 10.33696/pharmacol.4.030 -
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 -
Immune checkpoint inhibitors in BCG-unresponsive non-muscle-invasive bladder cancer: a narrative review of evidence and future directions.
Zhao L, Yang JW, Chen SY, Wang L, et al · · 2026 · PMID 41658461 · DOI 10.21037/tau-2025-717 -
Combination Strategies to Enhance Bacillus Calmette-Guérin Efficacy for Nonmuscle-Invasive Bladder Cancer.
Wald G, Lang J, Alkazemi H, Zhang A, et al · · 2026 · PMID 41270196 · DOI 10.1097/ju.0000000000004848 -
Nadofaragene firadenovec: a breakthrough in the field of bladder oncology.
Nadeem A, Qamar K, Bilal W, Vohra LI, et al · · 2023 · PMID 40778028 · DOI 10.3389/fruro.2023.1206398
Verify or expand the search:
- PubMed search for NCT04738630
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HX008
Trials testing the same drug.
- NCT07054307 — MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinom · Phase 1 · recruiting
- NCT05652894 — A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal · Phase 3 · not yet recruiting
- NCT04741165 — Study of HX008 in Combination With Bevacizumab or Lenvatinib for the Treatment of Advanced Hepatocellular Carcinoma (HCC · Phase 2 · unknown
- NCT04574817 — Study of HX008 for the Treatment of Anaplastic Thyroid Cancer (ATC) · Phase 2 · unknown
- NCT04750083 — HX008 Plus Chemotherapy VS Pembrolizumab Plus Chemotherapy As the First-line Treatment in Participants With Advanced or · Phase 2, PHASE3 · unknown
Other recruiting trials for Bladder Cancer
Currently open trials in the same condition.
- NCT07419295 — A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031) · Phase 3 · recruiting
- NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
- NCT07420517 — Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer · Phase 2 · recruiting
- NCT07475403 — Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
- NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors · Phase 1 · recruiting
Other Taizhou Hanzhong biomedical co. LTD trials
Trials by the same sponsor.
- NCT05647954 — A Study of HX008 Plus Transcatheter Arterial Chemoembolization (TACE) in the First-Line Treatment of Subjects With Stage · Phase 3 · unknown
- NCT05652894 — A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal · Phase 3 · not yet recruiting
- NCT04741165 — Study of HX008 in Combination With Bevacizumab or Lenvatinib for the Treatment of Advanced Hepatocellular Carcinoma (HCC · Phase 2 · unknown
- NCT04574817 — Study of HX008 for the Treatment of Anaplastic Thyroid Cancer (ATC) · Phase 2 · unknown
- NCT04750083 — HX008 Plus Chemotherapy VS Pembrolizumab Plus Chemotherapy As the First-line Treatment in Participants With Advanced or · Phase 2, PHASE3 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04738630 (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 Taizhou Hanzhong biomedical co. LTD
- Last refreshed: 4 February 2021
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/NCT04738630.
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