Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)

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

Trial Details

NCT ID
NCT07871110
Phase
PHASE2
Sponsor
TransThera Sciences (Nanjing), Inc.
Status
RECRUITING
Cancer Type
Prostate Cancer
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
Locations (sample)
  • Fuzhou, Fujian, China|26.06139,119.30611
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Wuhan, Hubei, China|30.58333,114.26667
  • Wuhan, Hubei, China|30.58333,114.26667

Key Eligibility Criteria

  • Male aged \>= 18 years at the time of signing the informed consent form (ICF).
  • Histologically or cytologically confirmed prostate adenocarcinoma; neuroendocrine differentiation after prior treatment is permitted (patients with…
  • Baseline imaging confirming metastatic lesions in bone (\>=2 bone lesions) or soft tissue; lesions identified only by PET imaging are not acceptable.
  • Receipt of continuous medical castration for \>=90 days or prior surgical castration, with serum testosterone \< 50 ng/dL (1.73 nmol/L) within 28 d…

For full eligibility, visit ClinicalTrials.gov.

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