Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyzna w wieku 18 lat lub starszy
- •Potwierdzony rozpoznaniem raka prostaty
- •Przerzuty nowotworu widoczne w badaniach obrazowych (co najmniej 2 ogniska w kościach)
- •Zastosowana kastracja medyczna lub chirurgiczna przez co najmniej 90 dni
- •Potwierdzony zwrot nowotworu po leczeniu nowymi terapiami hormonalnymi
- •Dobry ogólny stan zdrowia (wskaźnik wydolności ECOG ≤1)
- •Prawidłowa funkcja organów i szpiku kostnego
- •Może udział jedynie po wyrażeniu świadomej zgody
✗ Disqualifies
- •Wcześniejsze leczenie inhibitorami kinaz tyrozyny (TKI)
- •Wcześniejsze leczenie darolutamidem lub enzalutamidem (poza przypadkami krótszymi niż 1 miesiąc)
- •Niekontrolowane nadciśnienie tętnicze
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 13, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (16)
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Zhongnan Hospital of Wuhan University
Wuhan, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, China
Nantong Cancer Hospital
Nantong, China
Shandong Cancer Hospital and Institute, Shandong First Medical University
Jinan, China
Sichuan Cancer Hospital
Chengdu, China
Zhejiang Provincial People's Hospital
Hangzhou, China
The First Hospital of Jiaxing
Jiaxing, China
The First Affiliated Hospital of Ningbo University
Ningbo, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Peking University Third Hospital
Beijing, China
Chongqing University Cancer Hospital
Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Trial contact
Caixia Sun, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/14/2026.
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