NCT06470672尚未招募2 期
A Phase 2 Study of SHR-A1921 Combined Adebrelimab in Endocrine Therapy-failed HR-positive, HER2-negative Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- ORR by investigator
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
SHR-A1921+Adebrelimab
Experimental
Via intravenous infusion
干预措施: SHR-A1921 (Drug)
SHR-A1921+Adebrelimab
Experimental
Via intravenous infusion
干预措施: Adebrelimab (Drug)
结局指标
主要结局
ORR by investigator
时间窗: At baseline, at the time point of every 6 weeks, up to 2 years
ORR (Objective response rate) is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1.
次要结局
- DCR by investigator(At baseline, at the time point of every 6 weeks, up to 2 years)
- OS (Overall Survival)(Up to 2 years)
- Safety (incidence rate of adverse event)(From time of informed consent provided to 3 months after the last dose of study therapy)
- PFS (Progression-Free Survival)(Up to 2 years)
- DoR (Duration of Response)(Up to 2 years)
研究者
Hongxia Wang
Chief Physician
Fudan University
研究点 (1)
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