A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets

CTTQ

Status and phase: Unknown; Phase 1

Conditions: Metastatic Castration-resistant Prostate Cancer

Treatments: Drug: TQB3720

Study type: Interventional

Funder types: Industry

Identifiers

NCT04853498

TQB3720-I-01

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 1 patient group

TQB3720 tablets

Experimental group

Description:

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

Treatment:

Drug: TQB3720