Combining HRS-8080 and SHR-A2009 with anti-cancer therapy for advanced breast cancer

A Multi-center, Open-label Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer

This study is testing if combining two new drugs, HRS-8080 and SHR-A2009, with standard cancer treatments can help people with advanced breast cancer feel better and respond to therapy.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Adebrelimab, prednisone
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06222879 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and anti-cancer activity of various combinations of HRS-8080, SHR-A2009, and SHR-A1811 in patients with unresectable or metastatic breast cancer. Participants will receive one of the treatment combinations and will be monitored for their response to therapy. The study aims to determine if these combinations can effectively target and treat advanced breast cancer. Patients will need to provide tumor tissue samples for analysis and meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are females aged 18-75 with metastatic or locally advanced breast cancer and specific tumor characteristics.

Not a fit: Patients with early-stage breast cancer or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced breast cancer.

How similar studies have performed: Other studies have shown promise in using combination therapies for advanced breast cancer, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Females aged 18-75 years old (both ends inclusive);
2. ECOG performance status (PS) 0-1 points;
3. Patients with metastatic or locally advanced breast cancer confirmed by histology（ER positive, HER2 positive/negative，or triple negative breast cancer）.
4. Tumor tissue samples must be provided for detection of tumor markers;
5. Menopausal state;
6. Disease progression confirmed by imaging during or after the last systemic treatment before enrollment;
7. There must be at least one measurable extracranial lesion that complies with RECIST v1.1;
8. Expected survival \>3 months;
9. Good functional level of the organs ;
10. Female subjects with childbearing potential must agree to use highly effective contraceptive measures during the study treatment period and within 7 months after the end of the study treatment period; female subjects with childbearing potential must agree to use serum serum within 7 days before study enrollment. The HCG test must be negative and the patient must be non-lactating;
11. Voluntarily participate in this clinical trial, be willing and able to comply with clinical visits and research-related procedures, understand the research procedures and have signed informed consent.

Exclusion Criteria:

1. Patients with active (without medical control or clinical symptoms) brain metastasis;
2. Have the following lung diseases or history;
3. History of clinically severe cardiovascular disease;
4. Those who have received immunosuppressants or systemic hormone therapy for immunosuppression within 2 weeks before the first dose (dose \>10 mg/d prednisone or other corticosteroids at equivalent physiological doses), excluding nasal spray or inhaled hormones;
5. The damage caused by the subject receiving other treatments has not recovered (severity level NCI-CTCAE V5.0 classification ≤1, excluding hair loss and other adverse events judged to be tolerable by the researcher);
6. There are serious infections within 4 weeks before the first medication;
7. Untreated active hepatitis;
8. The subject has suffered from other malignant tumors in the past 5 years or currently, excluding cured cervical carcinoma in situ, cutaneous basal cell carcinoma and squamous cell carcinoma;
9. Presence of active autoimmune disease;
10. Have a history of immunodeficiency, including acquired (HIV infection), congenital immunodeficiency diseases, or a history of organ transplantation (including allogeneic bone marrow transplantation);
11. The subject is in the acute infection stage or active tuberculosis and requires drug treatment;
12. Known to be allergic to the components of HRS-8080, SHR-A1811 and its components, SHR-A2009 and its components, and Adebrelimab; have a history of severe allergic reactions to other monoclonal antibodies;
13. Patients who have other serious physical or mental illnesses or laboratory test abnormalities that may increase the risk of participating in the study or interfere with the results of the study, and who the researcher believes are not suitable for participation in this study.

Where this trial is running

Changsha, Hunan

• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Na An

Conditions Breast Cancer