NCT06555068

A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients

An Open-Label, Multi-Center Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Patients With Advanced Unresectable or Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 528 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to evaluate the safety, PK and efficacy of HRS-6209 in Combination with Fulvestrant, Letrozole, HRS-8080, or HRS-1358 for advanced unresectable or metastatic breast cancer

Conditions

• Advanced Unresectable or Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	HRS-6209 in Combination with Fulvestrant	HRS-6209 in Combination with Fulvestrant
DRUG	HRS-6209 in Combination with HRS-1358	HRS-6209 in Combination with HRS-1358
DRUG	HRS-6209 in Combination with Letrozole	HRS-6209 in Combination with Letrozole
DRUG	HRS-6209 in Combination with HRS-8080	HRS-6209 in Combination with HRS-8080
DRUG	HRS-6209 in Combination with HRS-1358	HRS-6209 in Combination with HRS-1358

Timeline

• Start date: 2024-08-12
• Primary completion: 2025-12-01
• Completion: 2026-08-01
• First posted: 2024-08-15
• Last updated: 2025-06-22

Locations

1 site across 1 country: China