A Phase 1, Multicenter, Open-label Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 285
- 试验地点
- 18
- 主要终点
- Numbers of subjects with adverse events
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of IBI3020.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Participants must satisfy all of the following criteria to be enrolled into the study:
- •Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
- •Male or female participants ≥ 18 years old. For Part 1, age ≥ 18 years and ≤ 75 years;
- •Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumors which have received available standard therapies and have disease progression, or unacceptable toxic effects, or contraindications;
- •At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
- •Minimum life expectancy of 12 weeks;
- •Adequate bone marrow and organ function confirmed at screening period;
- •Participants, both male and female, who are not of childbearing potential or who agree to use at least 1 highly effective method of contraception during the study.
排除标准
- •Participants who meet any of the following criteria will be disqualified from entering the study:
- •Previous treatment with CEACAM5-targeted therapy;
- •Prior anti-cancer therapy within the wash-out period;
- •Received live vaccines within 4 weeks or cancer vaccine within 3 months;
- •Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives;
- •Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI CTCAE v5.0;
- •Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients;
- •Undergone major surgery within 4 weeks, or who have severe unhealed wounds;
- •Known symptomatic central nervous system (CNS) metastases;
- •Uncontrolled diseases or conditions;
- •History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases;
- •History of thromboembolic event within 6 months;
- •Under neurological, psychiatric or social condition;
- •Women who are pregnant, have positive results in pregnancy test or are lactating;
- •Not eligible to participate in this study at the discretion of the investigator;
- •Participating in any other interventional clinical research.
研究组 & 干预措施
IBI3020
干预措施: IBI3020 (Drug)
结局指标
主要结局
Numbers of subjects with adverse events
时间窗: Up to 3 years
defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Number of subjects with clinically significant changes in physical examination results
时间窗: Up to 3 years
Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in electrocardiogram
时间窗: Up to 3 years
Clinically significant abnormal electrocardiogram findings reported by the investigator.
Dose limiting toxicities (DLTs)
时间窗: Up to 21 days
Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
objective response rate (ORR)
时间窗: Up to 3 years
objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
Number of subjects with clinically significant changes in vital signs
时间窗: Up to 3 years
Vital signs including body temperature, pulse, respiratory rate, oxygen saturation by pulse oximetry at rest and blood pressure
Number of subjects with clinically significant changes in laboratory parameters
时间窗: Up to 3 years
Clinically significant abnormal laboratory parameters findings reported by the investigator.
次要结局
- time to response (TTR)(Up to 3 years)
- progression free survival (PFS)(Up to 3 years)
- area under the curve (AUC)(Up to 3 years)
- time to maximum concentration (Tmax)(Up to 3 years)
- clearance (CL)(Up to 3 years)
- apparent volume of distribution (V)(Up to 3 years)
- half-life (t1/2)(Up to 3 years)
- anti-drug antibody (ADA)(Up to 3 years)
- objective response rate (ORR)(Up to 3 years)
- duration of response (DoR)(Up to 3 years)
- disease control rate (DCR)(Up to 3 years)
- maximum concentration (Cmax)(Up to 3 years)
- overall survival (OS)(From date of randomization until the date of first documented date of death from any cause, assessed up to 36 months)