NCT06663748尚未招募2 期
Evaluate the Efficacy and Safety of ARX788 Given Every 6 Weeks in Patients with HER2-positive 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
- 44
- 主要终点
- Objective remission rate (ORR)
研究概览
简要总结
A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.
详细描述
A single arm, phase 2 study of ARX788 in HER2-positive, metastatic breast cancer patients. The ARX788 will be administered every 6 weeks (Q6W) intravenous (IV) infusion.
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
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years old (including upper and lower limits), male or female;
- •Unresectable locally advanced, recurrent or metastatic BC;
- •Has previously received ≤ two lines of chemotherapy (excluding hormone therapy) for recurrent or metastatic BC;
- •Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
- •Has at least one measurable target lesion as per RECIST1.1 criteria;
- •Has recovered from any AE (≤ Grade 1) related to prior surgery and prior cancer treatment;
- •Adequate bone marrow, liver, kidney and coagulation function;
- •ECOG Performance Status Score of 0-1;
- •Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.
排除标准
- •Has known history to be allergic to any active ingredient or excipient of ARX788;
- •With meningeal metastases or disseminated brain metastases or active brain metastases, who need radiation, surgery or drug therapy;
- •Has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment;
- •Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease;
- •Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;
- •Has cardiac insufficiency;
- •Uncontrolled hypertension;
- •Has evidence of severe or uncontrollable systemic diseases;
- •Received live vaccines within 4 weeks before the first use of the investigational product or plans to receive live vaccines during the trial;
- •Breastfeeding female, or who has childbearing potential with a positive baseline pregnancy test or who is unwilling to use effective contraception during the trial;
- •Is unwilling or unable to stop wearing corneal contact lens during the trial;
- •Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product;
- •Has any mental or cognitive disorder that may restrict his/her understanding and execution of the informed consent form;
- •Other conditions that the Investigator considers inappropriate for participation in this trial, such as poor compliance.
研究组 & 干预措施
ARX788
Experimental
干预措施: ARX788 (Drug)
结局指标
主要结局
Objective remission rate (ORR)
时间窗: up to 2 years
ORR is defined as the percentage of participants in the analysis population who have CR or PR per RECIST 1.1.
次要结局
- Disease control rate (DCR)(up to 2 years)
- Duration of relief (DOR)(From response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first, assessed up to 2 years.)
- Progression-free survival (PFS)(From first dose to first documented disease progression (PD) or death from any cause, whichever occurred first, assessed up to 2 years.)
- Overall survival (OS)(From the date of first dose of study drug to any-cause death, assessed up to 5 years)
- The number of subjects experiencing adverse event TEAEs(up to 2 years)
- Pharmacokinetic parameter: Maximum concentration (Cmax)(At the end of Cycle 1 (each cycle is 42 days))
- Pharmacokinetic parameter: Time to Cmax (tmax)(At the end of Cycle 1 (each cycle is 42 days))
- Pharmacokinetic parameter: Terminal half-life (t1/2)(At the end of Cycle 1 (each cycle is 42 days))
- Pharmacokinetic parameter: Area under the concentration-time curve from zero extrapolated to infinity [AUC(0-inf)](At the end of Cycle 1 (each cycle is 42 days))
- Pharmacokinetic parameter: Area under the concentration-time curve from zero to the last quantifiable concentration [AUC(0-last)](At the end of Cycle 1 (each cycle is 42 days))
- Pharmacokinetic parameter: Terminal rate constant (λz)(At the end of Cycle 1 (each cycle is 42 days))
- Pharmacokinetic parameter: Systemic clearance (CL)(At the end of Cycle 1 (each cycle is 42 days))
- Pharmacokinetic parameter: Volume of distribution (Vz)(At the end of Cycle 1 (each cycle is 42 days))
- Pharmacokinetic parameter: Volume of distribution at steady state (Vss)(At the end of Cycle 3 (each cycle is 42 days))
- Pharmacokinetic parameter: Trough concentration (Ctrough)(At the end of Cycle 3 (each cycle is 42 days))
研究者
Min Yan, MD
Chief Physician
Henan Cancer Hospital
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