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

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

NCT ID: NCT06470672

Condition: Advanced Breast Cancer
Hormone-receptor-positive Breast Cancer
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: SHR-A1921
Description: Anti-TROP-2 ADC
Arm group label: SHR-A1921+Adebrelimab

Intervention type: Drug
Intervention name: Adebrelimab
Description: PD-L1 inhibitor
Arm group label: SHR-A1921+Adebrelimab

Summary: Our study is aimed to evaluate the efficacy and safety of novel ADC named SHR-A1921 combined with Adebrelimab in endocrine therapy-failed HR (Hormone Receptor)-positive, HER2-negative advanced breast cancer.

Criteria for 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.

Gender: Female

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan Cancer Hospital

Address:
City: Shanghai
Zip: 200230
Country: China

Contact:
Last name: Hongxia Wang

Phone: +8621-38196379
Email: whx365@126.com

Contact backup:
Last name: Zhonghua Tao

Phone: +86-13774315805
Email: drtaozhh@126.com

Start date: July 2024

Completion date: July 2026

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06470672