NCT06222879

Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer

A Multi-center, Open-label Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine if treatments with the combination of HRS-8080 and SHR-A1811, the combination of HRS-8080 and SHR-A2009, the combination of SHR-A2009 and SHR-1316 are safe, tolerable, and has anti-cancer activity in patients with unresectable or metastatic breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	HRS-8080; SHR-A1811	Participants will receive HRS-8080 and SHR-A1811
DRUG	HRS-8080; SHR-A2009	Participants will receive HRS-8080 and SHR-A2009
DRUG	SHR-A2009; SHR-1316	Participants will receive SHR-A2009 and SHR-1316

Timeline

• Start date: 2024-02-20
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2024-01-25
• Last updated: 2024-11-25

Locations

1 site across 1 country: China