drugset / Trial / NCT06851442
Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced or Metastatic Hormone Receptor(HR)-Positive and Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
This trial was designed to evaluate the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) in subjects with TQB3912 tablets combined with fulvestrant injection and TQB3616 capsules for locally advanced or metastatic HR-positive and HER2-negative breast cancer.And the effectiveness of TQB3912 tablets combined with fulvestrant injection ±TQB3616 capsules in locally advanced or metastatic HR-positive and HER2-negative breast cancer subjects was evaluated by evaluating ORR, PFS, DOR, DCR, CBR, OS, etc., and at the same time, Assess its safety and pharmacokinetic (PK) characteristics.
Timeline
- Start
- 2025-05-16
- Primary completion
- 2025-11-20
- Completion
- 2025-11-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fulvestrant | Small molecule | 500 mg | — |
| Subject | TQB3616 | Small molecule | 80 mg | — |
| Subject | TQB3616 | Small molecule | 120 mg | — |
| Subject | TQB3912 | Small molecule | 120 mg | — |