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

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.

Timeline

Start

2022-01-01

Primary completion

2023-10-01

Completion

2024-01-01

Publications

• Background Center MM, Jemal A, Lortet-Tieulent J, Ward E, Ferlay J, Brawley O, Bray F. International variation in prostate cancer incidence and mortality rates. Eur Urol. 2012 Jun;61(6):1079-92. doi: 10.1016/j.eururo.2012.02.054. Epub 2012 Mar 8.
• Background Knudsen ES, Witkiewicz AK. The Strange Case of CDK4/6 Inhibitors: Mechanisms, Resistance, and Combination Strategies. Trends Cancer. 2017 Jan;3(1):39-55. doi: 10.1016/j.trecan.2016.11.006.
• Background Kase AM, Copland Iii JA, Tan W. Novel Therapeutic Strategies for CDK4/6 Inhibitors in Metastatic Castrate-Resistant Prostate Cancer. Onco Targets Ther. 2020 Oct 15;13:10499-10513. doi: 10.2147/OTT.S266085. eCollection 2020.
• Background First CDK 4/6 Inhibitor Heads to Market. Cancer Discov. 2015 Apr;5(4):339-40. doi: 10.1158/2159-8290.CD-NB2015-028. Epub 2015 Feb 23.
• Background Comstock CE, Augello MA, Goodwin JF, de Leeuw R, Schiewer MJ, Ostrander WF Jr, Burkhart RA, McClendon AK, McCue PA, Trabulsi EJ, Lallas CD, Gomella LG, Centenera MM, Brody JR, Butler LM, Tilley WD, Knudsen KE. Targeting cell cycle and hormone receptor pathways in cancer. Oncogene. 2013 Nov 28;32(48):5481-91. doi: 10.1038/onc.2013.83. Epub 2013 May 27.
• Background Frank S, Nelson P, Vasioukhin V. Recent advances in prostate cancer research: large-scale genomic analyses reveal novel driver mutations and DNA repair defects. F1000Res. 2018 Aug 2;7:F1000 Faculty Rev-1173. doi: 10.12688/f1000research.14499.1. eCollection 2018.

Drugs

Indications