A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets

NCT04853498 | Terminated Phase 1

• 1 other identifier: TQB3720-I-01
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (1)

TQB3720 tablets

EXPERIMENTAL

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

Drug: TQB3720

Interventions

TQB3720 DRUG

This is an androgen receptor antagonists.

TQB3720 tablets

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.
• \. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200035, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 21, 2021
• Study Start: June 9, 2021
• Primary Completion: April 30, 2024
• Study Completion: December 30, 2025
• Last Updated: March 31, 2026

Record last verified: 2025-12

Locations

CN (1)