Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Condition(s) studied
Investigational drug(s) / intervention(s)
tinengotinib 10 mg QD plus darolutamide: Participants will receive tinengotinib 10 mg once daily with darolutamide in 21-day cycles per protocol defined schedule.
tinengotinib 10 mg QD (2-week on / 1-week off) plus darolutamide: Participants will receive tinengotinib 10 mg once daily (2-week on / 1-week off) with darolutamide in 21-day cycles per protocol defined schedule.
tinengotinib 10 mg QD plus enzalutamide: Participants will receive tinengotinib 10 mg once daily with enzalutamide in 21-day cycles per protocol defined schedule.
preferred combination regimen of tinengotinib plus one ARPI: Participants will receive preferred combination regimen of tinengotinib at optimized dose plus one ARPI in 21-day cycles per protocol defined schedule.
selected combination regimen of tinengotinib plus one ARPI: Participants will receive selected combination regimen of tinengotinib at optimized dose plus one ARPI in 21-day cycles per protocol defined schedule.
Darolutamide 600 mg twice daily: Participants will receive darolutamide 600 mg twice daily in 21-day cycles per protocol defined schedule.
Enzalutamide 160mg daily (oral): Participants will receive enzalutamide 160mg daily (oral) in 21-day cycles per protocol defined schedule.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Stage A: safety evaluation parameters — 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.
Including dose-limiting toxicities (DLTs), and incidence, duration, and severity of other adverse events (AEs) - Stage B: 6-month PFS rate (6mo-PFS) — From first study drug administration to the end of treatment, an average of 1 year.
The proportion of patients who remain alive without disease progression at 6 months after study treatment initiation. Tumor assessments are based on RECIST v1.1 and/or PCWG3. - Stage C: Radiographic progression-free survival (rPFS) — From first study drug administration to the end of treatment, an average of 1 year.
The time from randomization or treatment initiation to the first documented radiographic disease progression or death from any cause, whichever occurs first. Tumor assessments are based on RECIST v1.1 and/or PCWG3.
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | Not Yet Recruiting |
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | Not Yet Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | Not Yet Recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Not Yet Recruiting |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | Not Yet Recruiting |
| Affiliated Drum Tower Hospital, Medical School of Nanjing University | Nanjing | Jiangsu | Recruiting |
| Nantong Cancer Hospital | Nantong | Jiangsu | Not Yet Recruiting |
| Shandong Cancer Hospital and Institute, Shandong First Medical University | Jinan | Shandong | Not Yet Recruiting |
| Sichuan Cancer Hospital | Chengdu | Sichuan | Not Yet Recruiting |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | Not Yet Recruiting |
| The First Hospital of Jiaxing | Jiaxing | Zhejiang | Not Yet Recruiting |
| The First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang | Not Yet Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | Not Yet Recruiting |
| Peking University Third Hospital | Beijing | China | Not Yet Recruiting |
| Chongqing University Cancer Hospital | Chongqing | China | Not Yet Recruiting |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | China | Not Yet Recruiting |
More TransThera Sciences (Nanjing), Inc. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07871110 on ClinicalTrials.gov ↗ ← All trials in China