A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets

Phase 1

• Conditions: Metastatic Castration-resistant Prostate Cancer
• Interventions: Drug: TQB3720

• Registration Number: NCT04853498
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-21
• Study Start: 2021-06-19
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-24
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TQB3720 tablets	TQB3720	TQB3720 tablets administered orally, once daily in 28-day cycle.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD)	Baseline up to 28 days	MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.

Secondary Outcome Measures

Name	Time	Method
Cmax	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.	Cmax is the maximum plasma concentration of TQB3720 or metabolite(s).
AUC0-t	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.	To characterize the pharmacokinetics of TQB3720 by assessment of area under the plasma concentration time curve from zero to infinity.
Tmax	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.	To characterize the pharmacokinetics of TQB3720 by assessment of time to reach maximum plasma concentration.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China