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RECRUITING
NCT06167694
PHASE1/PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

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