NCT04162327已完成1 期
A Phase Ia/Ib, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI315, an Anti-HER2/PD-1 Bi-specific Antibody in Patients With HER2-expressing Advanced Solid Tumor
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve (AUC)
研究概览
简要总结
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI315, a HER2/PD-1 bi-specific antibody in patients with advanced solid tumors
详细描述
This phase Ia/Ib, open-label, multicenter study has two stages. The Ia stage is a dose-escalation study that will focus on safety, tolerability, efficacy and RP2D . Patients with HER2-expressing advanced solid tumor who failed from previous standard of care will be enrolled in the phase Ia study. DLT observation period is 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Written (signed) informed consent.
- •Life expectancy ≥12 weeks.
- •Patients with HER2-expressing advanced solid tumor who failed on current standard of care
- •According to RECIST 1.1, at least one measurable lesion (radiation-naïve) exists.
- •ECOG performance status 0-
- •Adequate organ and marrow function evaluated by laboratory tests as follow:
- •CBC: absolute neutrophil count (ANC) ≥ 1.0×109/L (Ia stage) or 1.5×109/L (Ib stage); Platelet (PLT) ≥ 75×109/L; Hemoglobin (HGB) ≥ 9.0g/L;
- •Liver function: Total bilirubin (TBIL) ≤ 1.5×upper limit of normal value (ULN) for patients without hepatic metastases, ≤ 2×ULN for patients with hepatic metastases or Gilbert syndrome; Alanine aminotransferase (ALT) ≤ 2.5×ULN; Aspartate transferase (AST) ≤ 2.5×ULN;
- •Renal function: Clearance of creatinine (CCr) by Cockcroft-Gault formula or 24-hour urine collection ≥ 50ml/min;
- •Urinalysis: urine protein < 2+ or urine protein in 24-hour urine collection < 1g;
- •Coagulation function: activated partial thromboplastin time (APTT）≤ 1.5×ULN; international normalized ratio (INR）≤ 1.5
- •left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography;
- •Accumulative exposure to doxorubicin ≤ 360mg/m2; accumulative exposure to epirubicin ≤ 720mg/m2;
- •Agree to use an approved contraceptive method during the treatment period, until 180 days after last dose of treatment.
- •Post-menopause female subject or pre-menopause female with negative HCG level in urine or blood.
排除标准
- •Any greater than NCI CTCAE 0/1 adverse event exists within 4 weeks before enrollment, not including hair loss and fatigue;
- •Received major surgery or having unhealed wound, ulcer, or bone fracture;• Received whole pelvic radiation;
- •Plan to receive any other anti-cancer therapy not specified in the protocol, except for palliative radiotherapy;
- •CNS metastasis, spinal compression, or carcinomatous meningitis
- •Active autoimmune disease or inflammatory disorders.
- •Primary immunodeficiency diseases;
- •Pregnant or breast-feeding female.
研究组 & 干预措施
Ia stage - IBI315 Dose escalation
Experimental
干预措施: IBI315 (Drug)
Ib stage - IBI315 monotherapy
Experimental
干预措施: IBI315 (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve (AUC)
时间窗: up to 9 months
Maximum plasma concentration (Cmax)
时间窗: up to 9 months
Terminal elimination half-life (T1/2)
时间窗: up to 9 months
Apparent volume of distribution (Vd)
时间窗: up to 9 months
次要结局
- Evaluate receptor occupancy (RO) following single-dose or multi-dose of IBI315(up to 9 months)
- The percentage of participants with anti-drug antibody (ADA) positive after dosing IBI315(up to 9 months)
- The percentage of participants with neutralizing antibody (NAb) positive after dosing IBI315(up to 9 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase I Study of IBI325 in Patients With Advanced Solid TumorSolid TumorNCT05119998Innovent Biologics (Suzhou) Co. Ltd.48
招募中
1 期
A Study of CBP-1008 in Patients With Advanced Solid TumorAdvanced Solid TumorNCT04740398Coherent Biopharma (Suzhou) Co., Ltd.143
Unknown
1 期
A Phase I Study of IBI325 in Patients With Advanced Solid TumorSolid TumorNCT05246995Shandong Cancer Hospital and Institute60
终止
1 期
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung CancersLung CancerOvarian CancerNCT06376253Novartis Pharmaceuticals4
招募中
1 期
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal CancersPancreatic Ductal AdenocarcinomaHR+/HER2- Ductal and Lobular Breast CancerTriple Negative Breast CancerColorectal CancerNon-small Cell Lung CancerNCT06562192Novartis Pharmaceuticals162