Status:
UNKNOWN
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Metastatic Castration-resistant Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE1
Brief Summary
This study is conducted to investigate the pharmacokinetic and safety profiles of TQB3720 in patients with metastatic castration-resistant prostate cancer.
Eligibility Criteria
Inclusion
- 1\. Histologically or cytologically confirmed prostate carcinoma. 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥12 weeks.
- Testosterone levels \< 50 ng/dL. 4. Has received ≥1 previous regimens for metastatic castration-resistant prostate cancer.
- Male subjects should agree to use an adequate method of contraception starting with signing ICF through 6 months after the last dose of study.
- Understood and signed an informed consent form.
Exclusion
- Has symptomatic brain metastases or control of symptoms \< 1 month. 2.Has other malignancies within 3 years. 3.Has used second-generation androgen receptor antagonists. 4. Abnormal liver function. 5. Abnormal renal function. 6. Has received any other investigational drug within 30 days weeks before first dose.
- 7\. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Key Trial Info
Start Date :
June 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04853498
Start Date
June 19 2021
End Date
May 30 2023
Last Update
November 24 2021
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200035