NCT06433609招募中2 期
A Phase II Study of Antibody-Drug Conjugates (ADCs) Combined With Adebrelimab in HER2-negative Advanced Breast Cancer
Beijing GoBroad Hospital1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2024年8月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- ORR (objective response rate) by investigator
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
SHR-A2102 + adebrelimab
Experimental
干预措施: SHR-A2102 (Drug)
SHR-A1811+adebrelimab
Experimental
干预措施: SHR-A1811 (Drug)
SHR-A2102 + adebrelimab
Experimental
干预措施: Adebrelimab (Drug)
SHR-A1921+adebrelimab
Experimental
干预措施: SHR-A1921 (Drug)
SHR-A1921+adebrelimab
Experimental
干预措施: Adebrelimab (Drug)
SHR-A1811+adebrelimab
Experimental
干预措施: Adebrelimab (Drug)
结局指标
主要结局
ORR (objective response rate) by investigator
时间窗: 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
ORR 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 (disease control rate) by investigator(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(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)(up to 3.5 years)
- PFS (progression-free survival)(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)(up to 3.5 years)
- Safety as assessed by percentage of patients with any Adverse Event (AE)(up to 3.5 years)
研究者
Wei Zhao
Attending physician
Beijing GoBroad Hospital
研究点 (1)
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