NCT07173556

A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer

Evaluation of Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of QLC1401 Tablets Combined With CDK4/6 Inhibitors or mTOR Inhibitors in Patients With Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Locally Advanced or Metastatic Breast Cancer: A Phase Ib/II Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	QLC1401	CDK4/6 inhibitors: Palbociclib, Abemaciclib, Ribociclib
DRUG	QLC1401	mTOR inhibitors: Everolimus

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-02-01
• Completion: 2028-10-01
• First posted: 2025-09-15
• Last updated: 2025-09-15