Study of SHR-A1921 Combined Adebrelimab in HR-positive, HER2-negative Advanced Breast Cancer

Launched by FUDAN UNIVERSITY · Jun 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination for women with advanced breast cancer that is hormone-receptor positive and HER2 negative. The treatment involves two drugs: SHR-A1921, which is an antibody-drug conjugate designed to target cancer cells, and Adebrelimab, which is a type of immunotherapy that helps the body’s immune system fight cancer. The goal is to see how effective and safe this combination is for women whose cancer has progressed despite receiving previous hormone therapies.

To participate in the trial, women must be between 18 and 75 years old, have confirmed advanced breast cancer that is hormone-receptor positive and HER2 negative, and have experienced disease progression after at least two prior hormone treatments. They also need to have measurable cancer that can be tracked during the study. Participants can expect to receive regular check-ups and assessments throughout the trial to monitor their health and the effectiveness of the treatment. It’s important to note that the trial is not yet recruiting participants, so interested individuals should keep an eye out for updates on when they can join.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 18 years to 75 years old, female patients with breast cancer;
• • ECOG PS Score: 0\~1;
• • Histologically or cytologically confirmed HR-positive, HER2-negative advanced or metastatic breast cancer;
• • PD-L1 positive;
• • Disease progression after at least prior 2 lines of endocrine therapy, and unable to benefit from further endocrine therapy determined by investigator, of which at least one line of CDK4/6 inhibitor-based treatment; if recurrence or metastasis within 2 years after completion of adjuvant endocrine therapy, marked as first-line treatment;
• • Prior at least 1 line of systemic chemotherapy in recurrent or metastatic setting;
• • Based on RECIST v1.1, at least one measurable lesion;
• • Patients must have a life expectancy ≥ 3 months;
• • Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);
• • Women of childbearing potential (WOCBP) should agree to use an effective method of contraception and no lactation from the initiation of screening to 7 months after the last dose of study therapy; WOCBP should have a negative serum pregnancy result within 7 days before the first dose of study therapy;
• • Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.
• Exclusion Criteria:
• • Has leptomeningeal metastasis confirmed by MRI or lumbar puncture;
• • Has CNS metastasis confirmed by radiology, except following conditions: ①asymptomatic brain metastasis that is not required to radiotherapy or surgery immediately; ②prior local therapy (e.g. radiotherapy or surgery) for brain or dural metastasis, of which stable disease lasting at least 4 weeks confirmed by radiography, and symptomatic therapy (e.g. hormone, mannitol, bevacizumab) has been stopped beyond 2 weeks with no clinical symptom;
• • Prior anti-TROP-2 treatment;
• • Has received or been receiving PD-(L)1 inhibitors and/or ADC containing a topoisomerase inhibitor-like payload;
• • Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g. drainage;
• • Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy or immunological therapy within 4 weeks before first dose of study therapy; has received antitumor endocrine therapy within one week before first dose of study therapy;
• • Use of other antitumor systemic treatment during the study;
• • Has active autoimmune disease or a history of autoimmune disease;
• • Known history of immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation;
• • Has active hepatitis B (HBsAg-positive and HBV DNA≥500 IU/mL), hepatitis C (positive for HCV antibody and HCV RNA above ULN) and hepatic cirrhosis;
• • Has an active infection requiring antibiotics, antiviral or antifungal treatment, or pyrexia \>38.5℃ of unknown origin during the screening period before first dose of study therapy (patients with pyrexia due to cancer could be enrolled determined by investigator);
• • Receiving immunosuppressive medication, or systemic corticosteroid therapy for the purpose of immunosuppression (prednisone at \>10mg/d or equivalent dose of other corticosteroids), and continuous use within 2 weeks before the first dose of study therapy;
• • Other malignancy within prior 5 years unless curatively treated with no evidence of disease for at least recent 3 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma or skin squamous cell carcinoma;
• • Hypersensitivity to study therapy or any of its excipients;
• • Has known clinically significant lung disease, including but not limited to: interstitial lung disease, pneumonitis, pulmonary fibrosis;
• • Known history of uncontrolled cardiovascular clinical symptom or disease that is not well controlled;
• • Has received a live vaccine within 4 weeks before first dose of study therapy, or potential to receive a live vaccine during the trial treatment;
• • Other conditions that might influence the study and analysis of results in the opinion of the investigator.