RecruitingPhase 1Phase 2NCT06167694

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


Sponsor

Shandong Suncadia Medicine Co., Ltd.

Enrollment

146 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — HRS-8080 (a hormone-blocking drug) and dalpiciclib (a drug that slows cancer cell growth) — in women with breast cancer that has spread or cannot be removed by surgery. Researchers are evaluating how safe the combination is and how well it works. **You may be eligible if...** - You are a woman aged 18 to 75 - You have hormone receptor-positive (HR+) breast cancer that is advanced or has spread to other parts of the body - You have at least one measurable tumor outside the brain - Your general health is good enough to perform daily activities (ECOG 0-1) - You are expected to live more than 3 months - You are not pregnant or breastfeeding, and are using effective contraception **You may NOT be eligible if...** - Your cancer has spread to internal organs causing serious symptoms - You have already received certain types of treatment that don't meet the study requirements - You have recently had major surgery or certain other cancer drugs Talk to your doctor to see if this trial is right for you.

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-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

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NCT06167694