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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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Female, aged 18-75 (inclusive);

• ECOG score 0-1;

• Estimated survival time ≥ 12 weeks;

• Possessing adequate bone marrow and organ function;

• Participants of reproductive/childbearing potential must agree to take adequate and effective contraceptive measures from the time they sign the informed consent form, during the study treatment period, and up to 2 years after the last use of the trial medication;

• Participants must provide informed consent for this study before the trial and voluntarily sign a written informed consent form.

Locations
Other Locations
China
West China Hospital, Sichuan University
RECRUITING
Chengdu
The Second Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
Contact Information
Primary
Yunxia Feng
yunxia.feng.yf29@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2026-03-27
Estimated Completion Date: 2028-12
Participants
Target number of participants: 180
Treatments
Experimental: Arm A: HRS-6208 + HRS-8080 ± HRS-6209
HRS-6208 + HRS-8080 ± HRS-6209.
Experimental: Arm B: HRS-6208 + Fulvestrant ± HRS-6209
HRS-6208 + Fulvestrant ± HRS-6209.
Experimental: Arm C: HRS-6208 + Letrozole ± HRS-6209
HRS-6208 + Letrozole ± HRS-6209.
Related Therapeutic Areas
Sponsors
Leads: Shandong Suncadia Medicine Co., Ltd.

This content was sourced from clinicaltrials.gov

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