Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT05156450
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.
Study:
NCT05156450
Study Brief:
Protocol Section:
NCT05156450