NCT06167694

Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer

A Multicenter, Open Phase Ib/II Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With ER-positive, HER2-negative Unresectable or Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion. Participants entering the study will receive HRS-8080 combined with Dalpiciclib Isethionate Tablets therapy.

Conditions

• Unresectable or Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	HRS-8080; Dalpiciclib Isethionate Tablets	HRS-8080 combined with Dalpiciclib Isethionate Tablets

Timeline

• Start date: 2023-12-20
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-12-12
• Last updated: 2026-01-09

Locations

2 sites across 1 country: China