NCT07871110
Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
StatusRecruiting
PhasePhase 2
Primary completion (estimated)
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Record History
All 1 version: 1 with changes below.
- Study First Submitted
Endpoints
Primary
Stage A: safety evaluation parameters
Timeframe: From signing of the informed consent until 28 days after the last dose or the end of the study (whichever occurs first), an average of 1 year.
Stage B: 6-month PFS rate (6mo-PFS)
Timeframe: From first study drug administration to the end of treatment, an average of 1 year.
Stage C: Radiographic progression-free survival (rPFS）
Timeframe: From first study drug administration to the end of treatment, an average of 1 year.
Arms and interventions
Stage A (tinengotinib plus darolutamide)Experimental
Stage A (tinengotinib (2-week on / 1-week off) plus darolutamide)Experimental
Stage A (tinengotinib plus enzalutamide)Experimental
Stage B (combination therapy)Experimental
optimized combination regimen
Stage C (combination therapy)Experimental
selected combination regimen
Stage C (ARPI monotherapy therapy)Active comparator
Stage C (physician choice)Active comparator
Drugs: 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)
Sites
16 sites in 1 country