Phase 2Recruiting
Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Progressing After Prior Treatment
- Sponsor
- TransThera Sciences (Nanjing), Inc. (Industry)
- Enrollment
- 182 planned
- Conditions
- Prostate Cancer (CRPC)
- Interventions
- tinengotinib 10 mg QD plus darolutamide; tinengotinib 10 mg QD (2-week on / 1-week off) plus darolutamide; tinengotinib 10 mg QD plus enzalutamide; preferred combination regimen of tinengotinib plus one ARPI; selected combination regimen of tinengotinib plus one ARPI; Darolutamide 600 mg twice daily; Enzalutamide 160mg daily (oral)
- Ages
- adults, older adults
- Registry
- NCT07871110
Full record on ClinicalTrials.gov
From the registry
The goal of this clinical trial is to learn if tinengotinib combined with darolutamide or enzalutamide works to treat participants with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior androgen receptor pathway inhibitors (ARPIs). It will also learn about the safety of the combination therapy. The main questions it aims to answer are: 1. If participants with mCRPC can benefit from the combination therapy of tinengotinib plus one ARPI? 2. What medical problems do participants have when taking the combination therapy? Participants will take tinengotinib with darolutamide or enzalutamide to find the optimal dose and regimen of tinengotinib for the combination therapy in stage A. In stage B, participants will take preferred combination regimen of tinengotinib plus darolutamide/enzalutamide identified in stage A. In stage C, researchers will compare selected combination therapy versus standard treatment and/or monotherapy to see if the combination therapy works better.
Primary outcomes
- Stage A: safety evaluation parameters
- Stage B: 6-month PFS rate (6mo-PFS)
- Stage C: Radiographic progression-free survival (rPFS）
History
Study completion expected
Primary completion expected
Registered
Started