Search / Trial NCT06222879

Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer

Launched by SHANDONG SUNCADIA MEDICINE CO., LTD. · Jan 15, 2024

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at new treatment combinations for women with advanced breast cancer that cannot be surgically removed or has spread to other parts of the body. Specifically, the study is testing whether the combinations of HRS-8080 with SHR-A1811, HRS-8080 with SHR-A2009, and SHR-A2009 with SHR-1316 are safe and effective in fighting cancer. The goal is to see if these treatments can help patients feel better and live longer.

To be eligible for this trial, participants need to be women aged 18 to 75 who have been diagnosed with metastatic or locally advanced breast cancer. They should have a measurable tumor that has shown disease progression recently and must be able to provide tumor tissue samples. Additionally, they should be in good health overall and willing to follow the study's procedures. Participants can expect regular visits for treatment and monitoring throughout the study. It's important to note that those with certain medical conditions, like uncontrolled brain metastasis or severe cardiovascular diseases, won't be able to join the trial.

Gender

FEMALE

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.

About Shandong Suncadia Medicine Co., Ltd.

Shandong Suncadia Medicine Co., Ltd. is a leading biopharmaceutical company based in China, dedicated to the research, development, and commercialization of innovative therapeutics. With a strong focus on enhancing patient outcomes, the company specializes in novel drug formulations and advanced treatment modalities across various therapeutic areas. Committed to rigorous scientific standards and quality assurance, Shandong Suncadia collaborates with global partners to drive clinical trials that align with international regulatory requirements, aiming to deliver safe and effective solutions to unmet medical needs.

Locations

Changsha, Hunan, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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