Spots Global Cancer Trial Database for TQB3616 Capsules Combined With Abiraterone Acetate Plus Prednisone in Metastatic Castration-Resistant Prostate Cancer

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Trial Identification

Brief Title: TQB3616 Capsules Combined With Abiraterone Acetate Plus Prednisone in Metastatic Castration-Resistant Prostate Cancer

Official Title: Phase Ib/II Clinical Study of TQB3616 Capsules in Combination With Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer

Study ID: NCT05156450

Conditions

Prostatic Neoplasms, Castration-Resistant

Drug Therapy, Combination

Interventions

TQB3616 Capsules Combined With Abiraterone Acetate Plus Prednisone

Study Description

Brief Summary: 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.

Detailed Description: TQB3616 is an inhibitor of Cyclin-dependent kinases 4 and 6 (CDK4/6), which reduces intracellular protein phosphorylation levels, prevents cells from entering synthesis (S) phase from first gap (G1) phase, and inhibits cell proliferation to combat tumors. TQB3616 has superior inhibitory activity to Palbociclib and Abemaciclib against CDK4/6 kinase and may benefit metastatic castration-resistant prostate cancer (mCRPC) patients through a complementary mechanism of action when combined with abiraterone acetate plus prednisone. Therefore, the investigators intend to perform this phase Ib/II clinical study of TQB3616 capsules in combination with abiraterone acetate plus prednisone in patients with mCRPC.