drugset / Trial / NCT07173556
A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is an open-label, multicenter, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets in combination with CDK4/6 inhibitors or mTOR inhibitors in patients with ER+/HER2- locally advanced or metastatic breast cancer. The study consists of two stages: a Phase Ib dose-escalation stage and a Phase II dose-expansion stage.
Timeline
- Start
- 2025-09
- Primary completion
- 2027-02
- Completion
- 2028-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | QLC1401 | Unknown | — | — |
| Background | Abemaciclib | Small molecule | — | — |
| Background | Everolimus | Small molecule | — | — |
| Background | Palbociclib | Small molecule | — | — |
| Background | Ribociclib | Small molecule | — | — |