Airui'en (rezvilutamide)

P2, N=70, Not yet recruiting, Sun Yat-sen University

P2, N=40, Recruiting, The First Affiliated Hospital of Xiamen University

P2, N=37, Recruiting, Peking University First Hospital

P2, N=88, Recruiting, Fudan University | N=66 --> 88

P2, N=102, Recruiting, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Concerning OS, ADT + abiraterone, ADT + abiraterone + docetaxel, ADT + apalutamide, ADT + bicalutamide, ADT + darolutamide + docetaxel, ADT + enzalutamide, ADT + orteronel, and ADT + rezvilutamide were more effective than the standard of care (SOC). Comparing PFS, most treatments were more effective than SOC, excluding ADT + bicalutamide, nilutamide, flutamide, ADT + bicalutamide + palbociclib, and ADT + nilutamide...Novel oral chemotherapeutic agent combination therapies must replace current ADT monotherapy and ADT + docetaxel SOC. Even so, ADT + docetaxel with ARTA triplet therapy still is not the best mHSPC treatment and requires further study.

Compared with androgen deprivation therapy (ADT) alone, rezvilutamide (REZ) [hazard ratio (HR) = 0.58, 95% confidence interval (CI): 0.44-0.77], abiraterone (ABI) (HR = 0.61, 95% CI: 0.53-0.71), apalutamide (APA) (HR = 0.70, 95% CI: 0.56-0.88), enzalutamide (ENZ) (HR = 0.65, 95% CI: 0.53-0.80), docetaxel (DOC) (HR = 0.72, 95% CI: 0.63-0.84), darolutamide (DAR) + DOC (HR = 0.49, 95% CI: 0.39-0.62), and ABI + DOC (HR = 0.52, 95% CI: 0.38-0.71) significantly improved OS in patients with high-volume mHSPC. According to the ranking analysis, triplet therapy ranked first, followed by ENZ and REZ. REZ + ADT were the highest ranked doublet therapy for improvement in OS of patients with high-volume mHSPC, second only to triplet therapy (DAR + DOC + ADT and ABI + DOC + ADT).

P2, N=66, Recruiting, Fudan University | Not yet recruiting --> Recruiting | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2025

P3, N=100, Recruiting, The First Affiliated Hospital with Nanjing Medical University

P1/2, N=125, Not yet recruiting, Fudan University

P2, N=66, Not yet recruiting, Fudan University

No abstract available

P1, N=52, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting | Initiation date: Dec 2022 --> Apr 2023

No abstract available

Specifically, abiraterone triplet therapy was ranked first in OS (HR, 0.52; 95% CrI:0.38-0.72) and rPFS (HR, 0.28; 95% CrI:0.21-0.38) among all therapies. ADT plus rezvilutamide was ranked first among doublet therapies (OS: HR, 0.58; 95% CrI:0.44-0.77; rPFS: HR, 0.44; 95% CrI:0.33-0.58)...ADT plus apalutamide was ranked first in OS among all therapies (HR:0.53, 95% CrI:0.35-0.79), whereas enzalutamide triplet therapy was ranked first in rPFS (HR:0.27, 95% CrI:0.15-0.51)...Docetaxel-based doublet or triplet therapies significantly increased the risk of any AEs or grade ≥3 AEs...Triplet therapy was associated with a higher risk of AEs than the other therapies. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022375347, identifier PROSPERO:CRD42022375347.

P1/2, N=140, Recruiting, Fudan University | Trial primary completion date: Jun 2022 --> Dec 2022

P1/2, N=140, Recruiting, Fudan University | Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jan 2022 --> Jun 2022

SHR3680 was well tolerated and safe, with promising anti-tumor activity across all doses tested in patients with metastatic CRPC. The dose of 240 mg daily was recommended for further phase 3 study.

P2, N=319, Recruiting, Fudan University | Not yet recruiting --> Recruiting | N=170 --> 319

P2, N=170, Not yet recruiting, Fudan University

Background: SHR3680 is a novel and pure androgen-receptor (AR) antagonist that shows a potent antitumor activity against CRPC but with much less brain distribution than enzalutamide in preclinical study. SHR3680 is safe and well tolerated, and exhibits high efficacy in mCRPC patients. Clinical trial information: NCT02691975. Research Funding: Jiangsu HengRui Medicine Co., Ltd., National Science and Technology Major Project of China.

Background: SHR3680 is a novel and pure androgen-receptor (AR) antagonist that shows a potent antitumor activity against CRPC but with much less brain distribution than enzalutamide in preclinical study. SHR3680 is safe and well tolerated, and exhibits high efficacy in mCRPC patients. Clinical trial information: NCT02691975. Research Funding: Jiangsu HengRui Medicine Co., Ltd., National Science and Technology Major Project of China.