Last reviewed · How we verify
NCT05156450
TQB3616 Capsules Combined With Abiraterone Acetate Plus Prednisone in Metastatic Castration-Resistant Prostate Cancer
Phase 2 trial testing TQB3616 Capsules Combined With Abiraterone Acetate Plus Prednisone in Prostatic Neoplasms, Castration-Resistant in 30 participants. Status unknown.
1 October 2023
Quick facts
| Lead sponsor | West China Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 January 2022 |
| Primary completion | 1 October 2023 |
| Estimated completion | 1 January 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- TQB3616 Capsules Combined With Abiraterone Acetate Plus Prednisone — full drug profile →
Conditions studied
- Prostatic Neoplasms, Castration-Resistant — all drugs for Prostatic Neoplasms, Castration-Resistant →
- Drug Therapy, Combination — all drugs for Drug Therapy, Combination →
Sponsor
West China Hospital
Who can join
Adults 18 to 80, male only, with Prostatic Neoplasms, Castration-Resistant or Drug Therapy, Combination. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase Ib/II clinical study of TQB3616 capsules in combination with abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer, to determine the dose for further clinical studies and to evaluate the safety and efficacy of this combined therapy.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cyclin-Dependent Kinase Inhibition in Prostate Cancer: Past, Present, and Future.
Siskin M, Economides MP, Wise DR. · · 2025 · cited 7× · PMID 40075623 · DOI 10.3390/cancers17050774 -
The Emerging Predictive and Prognostic Role of Aggressive-Variant-Associated Tumor Suppressor Genes Across Prostate Cancer Stages.
Pedrani M, Barizzi J, Salfi G, Nepote A, et al · · 2025 · cited 5× · PMID 39796175 · DOI 10.3390/ijms26010318 -
Interactions between key genes and pathways in prostate cancer progression and therapy resistance.
Wu F, Zhang H, Hao M. · · 2025 · cited 4× · PMID 39917165 · DOI 10.3389/fonc.2025.1467540 -
Cell-cycle targeted cancer therapy: clinical advances, biological gaps, and the emergence of selective CDK4 inhibitors.
Safaroghli-Azar A, Mekonnen LB, Lenjisa J, Milne R, et al · · 2026 · PMID 41943159 · DOI 10.1186/s13045-026-01794-7
Verify or expand the search:
- PubMed search for NCT05156450
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Prostatic Neoplasms, Castration-Resistant
Currently open trials in the same condition.
- NCT07225946 — A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Canc · Phase 3 · recruiting
- NCT06706921 — 18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer · Phase 4 · recruiting
- NCT06353386 — Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Particip · Phase 1, PHASE2 · recruiting
- NCT05743621 — Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer · Phase 1 · recruiting
- NCT05393791 — Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC · Phase 2 · recruiting
Other West China Hospital trials
Trials by the same sponsor.
- NCT07583654 — Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT07583914 — Safety, Tolerability, and Preliminary Antitumor Activity of Non-Cationic Peptide-CD47 siRNA in Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT07492914 — Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma · Phase 2 · recruiting
- NCT07507097 — Study on the Optimal Head Position for Patients With Severe Acute Ischemic Stroke · NA · not yet recruiting
- NCT07472933 — Vebotolimab Combined With Ptorlimab for EGFR-positive Refractory Advanced Biliary Tract Malignancies · Phase 2 · not yet 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 NCT05156450 (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 West China Hospital
- Last refreshed: 14 December 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/NCT05156450.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing