ArticleBMC cancer2026
Pharmacokinetics, safety, and efficacy of fuzuloparib in combination with abiraterone acetate and prednisone in patients with metastatic castration-resistant prostate cancer: a phase 1 dose escalation and expansion study.
Article in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04108247 (A Phase I Clinical Study of Abiraterone Combined With SHR3162 in the Treatment of Metastatic Castration-resistant Prostate Cancer), which is not on this map. Not yet cited in PubMed.
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A Phase I Clinical Study of Abiraterone Combined With SHR3162 in the Treatment of Metastatic Castration-resistant Prostate Cancer
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12 authors.
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Abstract
backgroundStudies have shown that poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors can potentiate the antitumor effect of abiraterone acetate plus prednisone (AA-P) in metastatic castration-resistant prostate cancer (mCRPC). This study evaluated the pharmacokinetics, safety, and efficacy of fuzuloparib, a PARP inhibitor, in combination with AA-P in mCRPC patients who had not received prior novel hormonal agents.
methodsThis was a dose escalation and expansion study. In dose escalation, eligible patients received fuzuloparib at 100 or 150 mg BID for 5 days, followed by fuzuloparib plus AA-P (abiraterone acetate 1000 mg QD, prednisone 5 mg BID) in 28-day treatment cycles. The higher tolerated dose of fuzuloparib was selected for dose expansion. In dose expansion, two treatment groups were planned. The fuzuloparib group received fuzuloparib for 5 days, and the abiraterone group received AA-P for 5 days. Both groups were then treated with the combination therapy.
resultsA total of 39 patients were enrolled and treated. As of July 12, 2023, the median follow-up time was 23.2 months (range, 3.9-44.3). No obvious drug-drug interaction was observed between 150 mg fuzuloparib and AA-P, and no dose-limiting toxicities were identified. Treatment-related adverse events (TRAEs) occurred in 36 (92.3%) patients, of which 20 (51.3%) reported grade ≥ 3 TRAEs. At the end of Week 12, prostate-specific antigen (PSA) response rate was 71.8% (95% CI, 55.1-85.0). The median time to PSA progression was 19.4 months (95% CI, 11.3-27.8). Objective response rate was 60% and disease control rate was 90% among patients with evaluable target lesions. The median duration of response was 8.1 months (95% CI, 4.6-31.5), and the median time to radiographic progression was 27.9 months (95% CI, 14.0-not reached). Time to disease progression was generally longer in patients with homologous recombination repair gene mutations, including those with BRCA mutations.
conclusionsFuzuloparib plus AA-P had an acceptable safety profile and showed promising efficacy among mCRPC patients.
trial registrationClinicalTrials.gov, NCT04108247 (Registered on September 26, 2019).
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