A new phase Ib/II study will evaluate the safety and efficacy of TY-302, a CDK4/6 inhibitor, combined with Abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC) who have failed novel endocrine therapies like enzalutamide or apalutamide.

Conducted as an open-label, multi-center trial, it aims to determine the maximum tolerated dose (MTD) and assess dose-limiting toxicities (DLT) in the dose-escalation phase, followed by an expansion phase to evaluate antitumor activity, including objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS). Secondary endpoints may include pharmacokinetics, overall survival, and quality of life.

TY-302 targets cyclin-dependent kinases 4 and 6 to halt cancer cell proliferation, while Abiraterone inhibits androgen production by blocking CYP17, a standard approach in mCRPC treatment. The combination seeks to address both cell cycle and androgen signaling pathways, potentially overcoming resistance in patients with limited treatment options. The trial focuses on a challenging patient population, as mCRPC often progresses despite therapies, leaving few alternatives.This study builds on the established role of Abiraterone and explores the emerging use of CDK4/6 inhibitors in prostate cancer, a field where such agents are less common compared to breast cancer.

Clinical trial.