Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer

Официальное название

A Phase II Study of Antibody-Drug Conjugates (ADCs) Combined With Adebrelimab in HER2-negative Advanced Breast Cancer

Обзор

Our study is aimed to evaluate the efficacy and safety of novel ADCs named SHR-A1811, SHR-A1921 and SHR-A2102 combined with adebrelimab in HER2-negative advanced breast cancer.

Вмешательства

• Препарат SHR-A1811
  Via intravenous infusion
• Препарат SHR-A1921
  Via intravenous infusion
• Препарат Adebrelimab
  Via intravenous infusion
• Препарат SHR-A2102
  Via intravenous infusion

Первичные конечные точки

• ORR (objective response rate) by investigator [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years]

Вторичные конечные точки (6)

• DCR (disease control rate) by investigator [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years]
• CBR (clinical benefit rate) by investigator [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years]
• DoR (duration of response) [Срок оценки: up to 3.5 years]
• PFS (progression-free survival) [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years]
• OS (overall survival) [Срок оценки: up to 3.5 years]
• Safety as assessed by percentage of patients with any Adverse Event (AE) [Срок оценки: up to 3.5 years]

Критерии участия

Критерии включения

• 18 years to 75 years old (including boundary values);
• ECOG PS Score: 0\~1;
• Histologically or cytologically confirmed HER2-negative advanced breast cancer;
• Disease progression after prior ≥1 line of systemic therapy; if HR-positive, prior CDK4/6 inhibitor is necessary;
• Based on RECIST v1.1, at least one measurable lesion;
• Brain metastasis with no clinical symptoms, or treated, stable brain metastases are eligible;
• Patients must have a life expectancy ≥ 6 months;
• Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);
• Women of childbearing potential should have a negative urine or serum pregnancy, and must promise to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy or be celibate; Men who are not surgically sterile (including those sterilized by methods other than bilateral orchiectomy \[e.g., vasectomy\]) and who intend to have sexual intercourse with female partners of childbearing potential must use a contraceptive method from enrollment, throughout the study, and for 6 months after the end of the study to prevent partner pregnancy;
• Available blood samples for ctDNA detection in the exploratory study;
• Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.

Критерии исключения

• Has known active brain metastasis which needs local therapy immediately;
• Prior use of ADCs with the same target as study drugs;
• Existence of third space fluid 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;
• Women with a positive serum or urine pregnancy test or who are breastfeeding; patients of childbearing potential who are unwilling or not available to use an effective method of contraception;
• Other conditions that might influence the study and analysis of results in the opinion of the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing GoBroad Hospital — Пекин

Идентификаторы

NCT: NCT06433609 · BJGBYY-IIT-LCYJ-2024-008 · BC-MUL-IIT-ADC-SHR1316

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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