OncoMatch/Clinical Trials/NCT07871110
Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Official title: 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
Is NCT07871110 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments for prostate cancer (crpc).
Treatment: 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) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: novel endocrine therapy (abiraterone)
Documented disease progression (per RECIST v1.1 and/or PCWG3) after >1 month of prior novel endocrine therapy (including abiraterone and AR inhibitors)
Cannot have received: tyrosine kinase inhibitor
Prior treatment with tyrosine kinase inhibitors (TKIs)
Cannot have received: androgen receptor inhibitor (darolutamide, enzalutamide)
Exception: treatment duration <= 1 month
Prior treatment with darolutamide or enzalutamide (except for treatment duration <= 1 month)
Lab requirements
Blood counts
Adequate organ and bone marrow function (no hematopoietic growth factors, blood transfusion or related blood products within 14 days before the first dose)
Adequate organ and bone marrow function (no hematopoietic growth factors, blood transfusion or related blood products within 14 days before the first dose)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07871110 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior tyrosine kinase inhibitor, androgen receptor inhibitor disqualifies patients from enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages