NCT06222879招募中1 期
A Multi-center, Open-label Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2024年2月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Recommended Phase 2 Dose（RP2D）
研究概览
简要总结
This study is designed to determine if treatments with the combination of HRS-8080 and SHR-A1811, the combination of HRS-8080 and SHR-A2009, the combination of SHR-A2009 and SHR-1316 are safe, tolerable, and has anti-cancer activity in patients with unresectable or metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 18-75 years old (both ends inclusive);
- •ECOG performance status (PS) 0-1 points;
- •Patients with metastatic or locally advanced breast cancer confirmed by histology（ER positive, HER2 positive/negative，or triple negative breast cancer）.
- •Tumor tissue samples must be provided for detection of tumor markers;
- •Menopausal state;
- •Disease progression confirmed by imaging during or after the last systemic treatment before enrollment;
- •There must be at least one measurable extracranial lesion that complies with RECIST v1.1;
- •Expected survival >3 months;
- •Good functional level of the organs ;
- •Female subjects with childbearing potential must agree to use highly effective contraceptive measures during the study treatment period and within 7 months after the end of the study treatment period; female subjects with childbearing potential must agree to use serum serum within 7 days before study enrollment. The HCG test must be negative and the patient must be non-lactating;
- •Voluntarily participate in this clinical trial, be willing and able to comply with clinical visits and research-related procedures, understand the research procedures and have signed informed consent.
排除标准
- •Patients with active (without medical control or clinical symptoms) brain metastasis;
- •Have the following lung diseases or history;
- •History of clinically severe cardiovascular disease;
- •Those who have received immunosuppressants or systemic hormone therapy for immunosuppression within 2 weeks before the first dose (dose >10 mg/d prednisone or other corticosteroids at equivalent physiological doses), excluding nasal spray or inhaled hormones;
- •The damage caused by the subject receiving other treatments has not recovered (severity level NCI-CTCAE V5.0 classification ≤1, excluding hair loss and other adverse events judged to be tolerable by the researcher);
- •There are serious infections within 4 weeks before the first medication;
- •Untreated active hepatitis;
- •The subject has suffered from other malignant tumors in the past 5 years or currently, excluding cured cervical carcinoma in situ, cutaneous basal cell carcinoma and squamous cell carcinoma;
- •Presence of active autoimmune disease;
- •Have a history of immunodeficiency, including acquired (HIV infection), congenital immunodeficiency diseases, or a history of organ transplantation (including allogeneic bone marrow transplantation);
- •The subject is in the acute infection stage or active tuberculosis and requires drug treatment;
- •Known to be allergic to the components of HRS-8080, SHR-A1811 and its components, SHR-A2009 and its components, and Adebrelimab; have a history of severe allergic reactions to other monoclonal antibodies;
- •Patients who have other serious physical or mental illnesses or laboratory test abnormalities that may increase the risk of participating in the study or interfere with the results of the study, and who the researcher believes are not suitable for participation in this study.
研究组 & 干预措施
Part A
Experimental
干预措施: HRS-8080; SHR-A1811 (Drug)
Part B
Experimental
干预措施: HRS-8080; SHR-A2009 (Drug)
Part C
Experimental
干预措施: SHR-A2009; SHR-1316 (Drug)
结局指标
主要结局
Recommended Phase 2 Dose（RP2D）
时间窗: up to 1 cycle (21 days)
Phase 1
Dose Limited Toxicity（DLT）
时间窗: up to 1 cycle (21 days)
Phase 1
Maximum Tolerable Dose（MTD）
时间窗: up to 1 cycle (21 days)
Phase 1
Safety endpoints: the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (rated based on CTCAE V5.0)
时间窗: up to 12 months
Phase 1
Efficacy endpoint: objective response rate (ORR)
时间窗: up to 12 months
Phase 2
次要结局
- Objective response rate (ORR)(up to 12 months)
- Disease control rate (DCR)(up to 12 months)
- level of SHR-A1811 ADA and Nab(up to 12 months)
- level of adebrelimab ADA and Nab(up to 12 months)
- Duration of response (DoR)(up to 12 months)
- Progression-free survival (PFS)(up to 12 months)
- Best overall response (BOR)(up to 12 months)
- Clinical benefit rate (CBR)(up to 12 months)
- level of SHR-A2009 ADA and Nab(up to 12 months)
- Safety endpoints: incidence and severity of AEs and SAEs (rated based on CTCAE V5.0)(up to 12 months)
研究者
研究点 (1)
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