Clinical trial · Interventional
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets
A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets
NCT04853498CI-TRIAL-00106917terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
Summary
Brief summary (as posted)
This study is conducted to investigate the pharmacokinetic and safety profiles of TQB3720 in patients with metastatic castration-resistant prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQB3720 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQB3720 tablets
- description
- TQB3720 tablets administered orally, once daily in 28-day cycle.
- interventionNames
- Drug: TQB3720
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Baseline up to 28 days
- description
- MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
Secondary outcomes (3)
- measure
- Cmax
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.