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Brief Title: To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer
Official Title: Phase Ib/II Clinical Study of TQB3823 Tablets Combined With Abiraterone Acetate Tablets and Prednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer
Study ID: NCT05405439
Brief Summary: This is a phase Ib/II clinical study to explore the safety and efficacy of TQB3823 tablets combined with abiraterone acetate tablets and prednisone acetate tablets in patients with metastatic castration-resistant prostate cancer.
Detailed Description: This is a two-phase, open-label Phase Ib clinical trial. The first phase plans to enroll 6-12 patients as two cohorts to explore the safety and of TQB3823 tablets combined with abiraterone and prednisone and the recommended dose of phase II of TQB3823. Subjects involved in cohort one accepts TQB3823 treatment during cycle one and then TQB3823 combined with abiraterone and prednisone from cycle two till the disease progression. The second phase plans to enroll a total of 40-60 subjects, aiming to evaluate the safety and efficacy of TQB3823 tablets combined with abiraterone and prednisone.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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The Southwest Hospitai of Amu, Chongqing, Chongqing, China
Chongqing Cancer Hospital, Chongqing, Chongqing, China
The Second Hospital of Harbin Medical University, Lanzhou, Gansu, China
Sun Yat-Sun University Cancer Prevertion and Treatment Center, Guangzhou, Guangdong, China
Qingyuan People's Hospital, Qingyuan, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
Affiliated Cancer Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Hunan Cancer Hospital, Changsha, Hunan, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
Shengjing Hospital Affiliated to China Medical University, Shenyang, Liaoning, China
Shandong Cancer Hospital, Jinan, Shandong, China
Huadong Hospital Affiliated to Fudan University, Shanghai, Shanghai, China
The First Affiliated Hospital of The Chinese People's Liberation Army Air Force Military Medical University, Xi'an, Shanxi, China
West China Hospital,Sichuan University, Chengdu, Sichuan, China
Sichuan Provincial People's Hospital, Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China
Mianyang Central Hospital, Mianyang, Sichuan, China
Zigong Fourth People's Hospital, Zigong, Sichuan, China
Cancer Hospital of Tianjin Medical University, Tianjin, Tianjin, China
The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
The First Affiliated Hospital of Wenzhou Medical Univerity, Wenzhou, Zhejiang, China