Clinical Trial

Efficacy and Safety of Tinengotinib Tablets Combined With Fulvestrant Injection in Patients With HR Positive and HER-2 Negative Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment

Recruiting Phase 2
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Summary
The goal of this clinical trial is to learn if tinengotinib combined with fulvestrant works to treat patients with HR-Positive and HER-2-Negative or low-expressing advanced breast cancer. It will also learn about the safety of combination therapy. The main questions it aims to answer are: 1. Does tinengotinib combined with fulvestrant reduce the tumor burden in participants? 2. What medical problems do participants have when taking the combination therapy? Participants will: Take tinengotinib and fulvestrant to find the optimal dose of tinengotinib for the combination therapy in Part A. In Part B, will take tinengotinib at the optimal dose with fulvestrant or tinengotinib alone to see if the combination therapy works better than tinengotinib monotherapy.
Trial Details
NCT Number NCT07498478
Lead Sponsor TransThera Sciences (Nanjing), Inc.
Conditions Breast Cancer
Enrollment 94 participants
Start Date 2026-03-17
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-27