A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets

Metastatic Castration-resistant Prostate Cancer Clinical Trial

Official title:

A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04853498
• Other study ID #: TQB3720-I-01
• Status: Recruiting
• Phase: Phase 1
• Start date: June 19, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: November 2021
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is conducted to investigate the pharmacokinetic and safety profiles of TQB3720 in patients with metastatic castration-resistant prostate cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1. Histologically or cytologically confirmed prostate carcinoma. 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy =12 weeks. 3.Testosterone levels < 50 ng/dL. 4. Has received =1 previous regimens for metastatic castration-resistant prostate cancer. 5.Male subjects should agree to use an adequate method of contraception starting with signing ICF through 6 months after the last dose of study. 6.Understood and signed an informed consent form. Exclusion Criteria: -1.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.

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• TQB3720
This is an androgen receptor antagonists.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)	MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.	Baseline up to 28 days
Secondary	Cmax	Cmax is the maximum plasma concentration of TQB3720 or metabolite(s).	0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8?day 15?day 22;0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56.
Secondary	Tmax	To characterize the pharmacokinetics of TQB3720 by assessment of time to reach maximum plasma concentration.	0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8?day 15?day 22;0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56.
Secondary	AUC0-t	To characterize the pharmacokinetics of TQB3720 by assessment of area under the plasma concentration time curve from zero to infinity.	0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8?day 15?day 22;0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56.