HRS-6208 combined with HRS-8080, fulvestrant, or letrozole (± HRS-6209) for advanced 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

This trial will test HRS-6208 given with HRS-8080, fulvestrant, or letrozole, with or without HRS-6209, in adults with advanced unresectable or metastatic breast cancer to see if the combinations are safe and can help control disease.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Dalian, Liaoning and 1 other locations)
• Trial ID: NCT07389733 on ClinicalTrials.gov

What this trial studies

This Phase 1/2, multicenter trial in China tests multiple combination regimens built around the investigational agent HRS-6208, administered with HRS-8080, fulvestrant, or letrozole, and optionally with HRS-6209. The study uses dose-escalation and expansion cohorts to characterize safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. Eligible participants are adult women with advanced unresectable or metastatic breast cancer and adequate organ function, treated at participating hospital sites. Key outcomes include adverse events, recommended phase 2 dose(s), pharmacokinetic profiles, and measures of tumor response or disease control.

Who should consider this trial

Good fit: Women aged 18–75 with advanced unresectable or metastatic breast cancer, ECOG 0–1, estimated survival ≥12 weeks, and adequate bone marrow and organ function are the intended participants.

Not a fit: Patients with active brain metastases, recent other malignancies within five years, severe bone damage, poor organ function, ECOG >1, or who cannot comply with study requirements are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the combinations could provide an additional treatment option that helps control disease for some patients with advanced breast cancer.

How similar studies have performed: Combining investigational targeted agents with endocrine therapies is an established strategy that has produced benefits in breast cancer, but the specific HRS-6208/HRS-8080/HRS-6209 compounds remain investigational and unproven.

Eligibility criteria

Inclusion Criteria:

1. Female, aged 18-75 (inclusive);
2. ECOG score 0-1;
3. Estimated survival time ≥ 12 weeks;
4. Possessing adequate bone marrow and organ function;
5. 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;
6. Participants must provide informed consent for this study before the trial and voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Within 5 years prior to the first dose of study medication, the occurrence of other malignancies, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, and post-radical surgery thyroid papillary carcinoma;
2. Active brain metastasis, carcinomatous meningitis, spinal cord compression, or history of primary central nervous system tumors;
3. Severe bone damage caused by tumor bone metastasis as determined by the investigator;
4. Adverse events caused by previous anti-tumor treatment have not been resolved;
5. Participants with one of multiple factors affecting oral medication;
6. History of severe cardiovascular and cerebrovascular diseases;
7. Presence of severe infections;
8. Significant clinically meaningful bleeding within 3 months prior to the first dose of study medication;
9. Active autoimmune diseases, history of immune deficiency, history of autoimmune diseases, or history of diseases or syndromes requiring systemic steroid hormone or immunosuppressive drug treatment, or acquired conditions (HIV infection), congenital immune deficiency diseases, or history of organ transplantation;
10. Active untreated hepatitis;
11. History of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without standard treatment;
12. Washout period of prior drug or treatment did not meet protocol requirements before the first dose of study medication;
13. Prior use of prohibited drugs specified in the protocol;
14. Is pregnant or breastfeeding or planning to become pregnant within 2 years after the last dose of study medication;
15. History of clear neurological or psychiatric disorders, and participants with a history of psychiatric drug abuse or drug addiction;
16. Allergic reactions to any study drug or excipients;
17. Factors confirmed by the investigator as unsuitable for participation in this clinical study.

Where this trial is running

Dalian, Liaoning and 1 other locations

• The Second Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Yunxia Feng

Conditions Advanced Unresectable or Metastatic Breast Cancer of Adults