NCT05774873已完成1 期
A Phase I/II Study of IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number of patients with treatment-related adverse events
研究概览
简要总结
This is open-label, multicenter, Phase I/II study is designed to evaluate the Safety and tolerability and Efficacy of IBI334 Monotherapy in participants with advanced solid tumors.
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
- •Subjects with 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 subjects ≥ 18 years old;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- •Anticipated life expectancy of ≥ 12 weeks;
- •At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1with Phase Ia ;At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with Phase Ib+II；
排除标准
- •Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
- •Received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study;
- •History of immunodeficiency disease, including congenital or acquired immunodeficiency diseases;
- •Severe allergic or hypersensitive to other EGFR or B7H3 antibodies or any ingredients of IBI334;
- •Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief, which must not affect tumor assessment throughout the study;
研究组 & 干预措施
IBI334 in advanced solid tumors
Experimental
干预措施: IBI334 (Drug)
结局指标
主要结局
Number of patients with treatment-related adverse events
时间窗: Up to 60 days post last dose
Percentage of subjects woth Dose-Limitine toxicities(DLTs)
时间窗: Up to 28 days following first dose
次要结局
- Preliminary efficacy : duration of response (DoR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria(Day 1 up to treatment duration reaches 24 months)
- Preliminary efficacy : disease control rate (DCR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria(Day 1 up to treatment duration reaches 24 months)
- Preliminary efficacy :time to response (TTR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria(Day 1 up to treatment duration reaches 24 months)
- PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: area under the curve (AUC)(Day 1 up to treatment duration reaches 24 months)
- PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to:maximum concentration (Cmax)(Day 1 up to treatment duration reaches 24 months)
- Preliminary efficacy ： objective response rate (ORR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria(Day 1 up to treatment duration reaches 24 months)
- PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: clearance (CL)(Day 1 up to treatment duration reaches 24 months)
- PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: apparent volume of distribution (V)(Day 1 up to treatment duration reaches 24 months)
- PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: half-life (t1/2).(Day 1 up to treatment duration reaches 24 months)
- Prevalence and incidence of anti-IBI334 antibodies.(Day 1 up to treatment duration reaches 24 months)
- Preliminary efficacy :overall survival (OS)(Day 1 up to treatment duration reaches 24 months)
- Preliminary efficacy :progression-free survival (PFS) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria(Day 1 up to treatment duration reaches 24 months)
研究者
研究点 (1)
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