A Phase 1 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- Number of subjects with clinically significant changes in physical examination results
研究概览
简要总结
This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants ≥ 18 years old;
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- •Has an anticipated life expectancy of ≥ 12 weeks;
- •Adequate bone marrow and organ function:
- •At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.
- •for dose escalation , and 1 measurable lesion for dose expansion.
- •Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks.
排除标准
- •Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan;
- •Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study;
- •Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
- •Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
- •Known symptomatic central nervous system (CNS) metastases.
- •History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
- •History of endotracheal or gastrointestinal stent implantation;
- •Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
- •Esophageal or gastric varices requiring immediate intervention;
- •Not eligible to participate in this study at the discretion of the investigator;
- •Do not have adequate treatment washout period before study drug administration. -
研究组 & 干预措施
Open-label: IBI3001 monotherapy
干预措施: IBI3001 (Drug)
结局指标
主要结局
Number of subjects with clinically significant changes in physical examination results
时间窗: 24 months
Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs
时间窗: 24 months
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Number of subjects with adverse events
时间窗: 24 months
Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria
MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs)
时间窗: 24 months
Dose limiting toxicity (DLT) to establish MTD or RP2D
次要结局
- Time to maximum concentration (Tmax) of IBI3001(24 months)
- Clearance (CL) of IBI3001(24 months)
- Half-life (T1/2) of IBI3001(24 months)
- Immunogenicity of IBI3001(24 months)
- Overall survival (OS)(24 months)
- Plasma concentration (Cmax) of IBI3001(24 months)
- Progression free survival (PFS)(24 months)
- Area under the curve (AUC) of IBI3001(24 months)
- Volume of distribution (V) of IBI3001(24 months)
- Objective response rate (ORR)(24 months)
- Time to response (TTR)(24 months)
- Disease control rate (DCR)(24 months)
- Duration of response (DoR)(24 months)