NCT04861948终止1 期
Phase Ib Study to Evaluate the Efficacy, Safety and Tolerability of IBI188 Combination Therapy in Subjects With Advanced Malignancies
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
A Phase Ib study aim to evaluate the efficacy, safety, and tolerability of IBI188 combination therapy in subjects with advanced malignancies
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with locally advanced or metastatic solid tumors cannot be cured by surgery or other local treatments .
- •Aged ≥ 18 years (≥ 12 years is acceptable in Cohort C).
- •Able to provide archived or fresh tumor tissue samples for biomarker assessment.
- •Have at least one measurable lesion according to RECIST version 1.
- •ECCG PS score of 0-
- •Adequate organ and bone marrow functions .
- •Life expectancy ≥ 12 weeks.
- •Female subjects of childbearing potential or male subjects with partners of childbearing potential should take effective contraceptive measures throughout the whole treatment period and until 6 months after treatment.
- •Must voluntarily sign the Informed Consent Form (ICF), and be able to follow all study requirements and procedures. For the subjects enrolled in Cohort C who are ≥ 12 and < 18 years old, in addition to obtaining the child's own consent, their guardians should provide informed consent and sign the ICF.
排除标准
- •Previous exposure to any CD47 antibody, SIRPα antibody, CD47/SIRPα recombinant protein or other inhibitors that act in the same pathway.
- •Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death-ligand (PD-L1) antibody (except Cohort C).
- •Concurrent participation in another clinical study.
- •The last dose of anti-tumor therapy is within 4 weeks before the first dose of study treatment.
- •Have undergone major surgical procedures within 4 weeks prior to the first dose of study treatment or planned to receive major surgery during the study treatment.
- •Presence of toxicities (excluding alopecia and fatigue) induced by previous anti-tumor therapy that has not recovered to Grade 0 or 1 as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 prior to the first dose of study treatment.
- •Known hypersensitivity to IBI188 or any ingredient in the study drug product.
- •History of other primary malignancies.
- •Female subjects who are pregnant or lactating.
- •Other ineligible conditions considered by the investigator.
研究组 & 干预措施
Cohort B
Experimental
干预措施: Bevacizumab (Drug)
Cohort A
Experimental
干预措施: IBI188 (Drug)
Cohort A
Experimental
干预措施: Sintilimab (Drug)
Cohort B
Experimental
干预措施: IBI188 (Drug)
Cohort B
Experimental
干预措施: Cisplatin/Carboplatin (Drug)
Cohort B
Experimental
干预措施: Pemetrexed (Drug)
Cohort C
Experimental
干预措施: IBI188 (Drug)
Cohort C
Experimental
干预措施: GM-CSF (Drug)
Cohort D
Experimental
干预措施: IBI188 (Drug)
Cohort D
Experimental
干预措施: Sintilimab (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 24 months
Adverse Events
时间窗: 24 months
Incidence, correlation with the study drug and severity of all adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)
次要结局
- Area Under Curve, AUC(24 months)
- Overall survival(24 months)
- Disease control rate(24 months)
- Time to response(24 months)
- Progression-free survival(24 months)
- Positive rate of neutralizing antibody (NAb)(24 months)
- clearance (CL)(24 months)
- Duration of response(24 months)
- maximum concentration (Cmax)(24 months)
- minimum concentration (Cmin)(24 months)
- volume of distribution (V)(24 months)
- half-life (t1/2)(24 months)
- Positive rate of anti-drug antibody (ADA)(24 months)
研究者
研究点 (1)
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