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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

NCT07498478 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tinengotinib at the optimal dose combined with Fulvestrant

Participants will receive tinengotinib at the optimal dose once daily with fulvestrant in 28-day cycles per protocol defined schedule.

DRUG

Tinengotinib

Participants will receive tinengotinib once daily in 28-day cycles per protocol defined schedule.

DRUG

tinengotinib combined with fulvestrant

Participants will take tinengotinib at the starting dose of 10 mg once daily with fulvestrant to determine the optimal dose of tinengotinib in combination with fulvestrant. If not tolerated, the dose of tinengotinib will be reduced to 8 mg or 6 mg once daily.

Sponsors & Collaborators

  • TransThera Sciences (Nanjing), Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-17
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07498478 on ClinicalTrials.gov