RecruitingPhase 1Phase 2NCT07389733

A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer

Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HRS-6208 in Combination With HRS-8080 ± HRS-6209, or in Combination With Fulvestrant ± HRS-6209, or in Combination With Letrozole ± HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer: an Open Label, Multicenter, Phase Ib/II Study

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Enrollment

180 participants

Start Date

Mar 27, 2026

Study Type

INTERVENTIONAL

Conditions

Advanced Unresectable or Metastatic Breast Cancer of Adults

Summary

This study aims to evaluate the safety, tolerability, efficacy and pharmacokinetics of HRS-6208 in combination with HRS-8080 ± HRS-6209, or in combination with fulvestrant ± HRS-6209, or in combination with letrozole ± HRS-6209 in patients with advanced unresectable or metastatic breast cancer.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Fulvestrant injection, a drug called HRS-6208 Capsule, and others for people with advanced unresectable or metastatic breast cancer of adults. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS-6208 Capsule

HRS-6208 capsule.

DRUGHRS-6209 Capsule

HRS-6209 capsule.

DRUGHRS-8080 Tablet

HRS-8080 tablet.

DRUGFulvestrant injection

Fulvestrant injection.

DRUGLetrozole tablets

Letrozole tablets.

Locations(2)

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT07389733