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Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer
Sponsor: Shandong Suncadia Medicine Co., Ltd.
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
146
Start Date
2023-12-20
Completion Date
2026-06
Last Updated
2026-01-09
Healthy Volunteers
No
Conditions
Interventions
HRS-8080; Dalpiciclib Isethionate Tablets
HRS-8080 combined with Dalpiciclib Isethionate Tablets
Locations (2)
Chinese PLA General Hospital Fifth Medical Center
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, China