NCT07244874
尚未招募
2 期
A Single Arm, Phase II Study of Sacituzumab Tirumotecan（Sac-TMT） Combined With Toripalimab for First-line Treatment of PD-L1 Positive Unresectable Locally Advanced/Metastatic Triple Negative Breast Cancer (a/mTNBC)
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 41
- 主要终点
- Objective response rate (ORR)
概览
简要总结
This study is aimed to evaluate the efficacy and safety of Sacituzumab Tirumotecan combined with Toripalimab for first-line treatment of PD-L1 positive unresectable Locally Advanced/metastatic triple negative breast cancer (a/mTNBC).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with breast cancer aged \>= 18 years.
- •Based on the pathological report of the latest biopsy or other pathological specimens, the histology and/or cytology are confirmed as invasive breast cancer, and the following conditions are met: a) Pathological classification: ER \<= 10%, PR \<= 10%; HER2 negative (IHC 0, 1+, 2+and FISH negative); Note: Subjects with initial histopathological diagnosis of HR\>10% or HER2+breast cancer and recent pathological findings of metastatic lesions meeting the above conditions are allowed to be included in the study. b) Tumor staging: locally advanced, recurrent, or metastatic tumors that cannot be surgically removed; Note: Patients who have received perioperative treatment in the past are required to have a disease-free survival period of \>= 6 months;
- •ECOG overall state is 0-
- •Have not received systematic treatment for advanced diseases.
- •There are tissue samples available for PD-L1 testing, and the test results show PD-L1 positive: CPS \>=
- •The expected survival period is not less than 3 months.
- •According to the RECIST v1.1 standard, there must be at least one measurable lesion present.
- •Having sufficient organ and bone marrow function (without receiving blood transfusion, recombinant human thrombopoietin or colony-stimulating factor therapy within 2 weeks prior to the first administration), defined as follows: a) Blood routine: neutrophil count (NEUT #) \>= 1.5 × 10\^9/L; platelet count (PLT) \>= 100 × 10\^9/L; hemoglobin \>= 90g/dL; b) Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) \<= 2.5 x upper limit of normal (ULN); Total bilirubin (TBIL) \<= 1.5 × ULN; For patients with liver metastases, ALT and AST should be \<= 5 × ULN, and TBIL should be \<= 2 × ULN; For patients with liver or bone metastases, ALP \<= 5 × ULN; c) Renal function: creatinine clearance rate (Ccr) \>= 60ml/min; d) Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) \<= 1.5 × ULN; e) Cardiac function: Echocardiography (ECHO) or multi circuit controlled acquisition (MUGA) scan shows left ventricular ejection fraction (LVEF) \>= 50%;
- •Patients must recover from all toxicity caused by previous treatment (to \<= grade 1, evaluated based on CTCAE 5.0, or meet the inclusion criteria of the protocol), except for hair loss and vitiligo.
- •Patients with negative serum pregnancy test results and those with fertility potential must agree to use effective non hormonal contraceptive methods during treatment and for at least 6 months after the last use of the test drug.
排除标准
- •Patients with central nervous system metastases.
- •Received radiotherapy, endocrine therapy, chemotherapy, surgical treatment (excluding local puncture or biopsy) or molecular targeted therapy during the recurrence/metastasis stage.
- •Participated in clinical trials of other drugs within 4 weeks prior to enrollment.
- •Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L-2, or anti-CTLA-4 antibodies, or any other antibodies or drugs that specifically target T cell co stimulatory or checkpoint pathways.
- •Previously used treatment targeting TROP2 and/or topoisomerase I inhibitors.
- •Other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cutaneous carcinoma, or squamous cell carcinoma of the skin.
- •Known history of allergies to the drugs and their components in this protocol.
- •Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.
- •History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •Vaccination with live vaccine within 30 days prior to the first study administration.
研究组 & 干预措施
Sacituzumab Tirumotecan + Toripalimab
Experimental
干预措施: Sacituzumab tirumotecan (Drug)
Sacituzumab Tirumotecan + Toripalimab
Experimental
干预措施: Toripalimab (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to approximately 15 months
次要结局
- Progression-Free-Survival(Up to approximately 15 moths)
- Duration of Response(Up to approximately 15 months)
- Overall Survival(Up to approximately 4 years)
- adverse events(Up to approximately 15 months)
研究者
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