BrUOG360: A Phase Ib/II Study of Copanlisib in Combination with Rucaparib in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).

ABSTRACT:

Purpose

Metastatic castration-resistant prostate cancer with homologous recombination (HR) deficiency (HRD) is sensitive to PARP inhibitors (PARPi). PI3K inhibitors (PI3Ki) sensitize to PARPi by disrupting HR in preclinical models. This phase Ib/II study investigated copanlisib (Copa; pan-class I PI3Ki) and rucaparib (R).

Patients and methods

Eligible patients had metastatic castration-resistant prostate cancer treated with ≥1 androgen receptor inhibitor and taxanes. Phase I followed a standard 3 + 3 dose-escalation design (rucaparib 400-600 mg orally twice a day; Copa 45-60 mg i.v. on days 1, 8, and 15). Primary goal of phase I was to establish MTD and the recommended phase II dose. The primary endpoint of phase II was PSA50 response rate.

Results

Thirteen patients e

SUBMITTER: De Souza AL 

PROVIDER: S-EPMC12690636 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature