NCT06365840招募中2 期
PHASE 2 STUDY OF IMC-001 IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED TMB-H SOLID TUMOR
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- ORR
研究概览
简要总结
The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented TMB-H:≥ 16 mut/Mb, determined by the TruSightTM Oncology 500 NGS panel or OncomineTM Comprehensive Assay Plus
- •Histologically or cytologically proven metastatic or locally advanced solid tumors.The participant must have at least one measurable tumor lesion per RECIST 1.
- •Investigator has confirmation that participant's tumor tissue is available to be submitted to a central pathology laboratory.
- •Adult age(as defined by respective country)
- •The nature of the study and voluntarily sign an ICF
- •Prior systemic radiation therapy must be completed at least 4 weeks before the first dose of study drug. Prior focal radiotherapy must be completed at least 2 weeks before the first dose of study drug.
- •At the time of the first dose of study drug at least 28 days since the last chemotherapy, immunotherapy, biological or investigational therapy, and have recovered from toxicities associated with such treatment to < Grade
- •Adequate hematologic function, hepatic function, and renal function
- •Female participants must meet one of the following criteria:
- •Postmenopausal (≥24 months, or ≥12 months with FSH > 40 IU/L),
- •surgically incapable of bearing children (i.e., has had a hysterectomy or bilateral oophorectomy); or
- •females of childbearing potential must agree to use a reliable form of contraceptive during the study treatment period and for at least 90 days following the last dose of study drug.
- •Male participants must agree to use barrier contraception (i.e., condoms) for the duration of the study and for at least 90 days after the last dose of study drug.
- •Predicted life expectancy of at least 16 weeks.
排除标准
- •Previously treated with an anti-PD-L1 or anti-PD-1 antibody
- •Known presence of symptomatic CNS metastases
- •Any active autoimmune disease or a documented history of autoimmune disease
- •Apparent active and known viral infection with HIV, hepatitis B virus or hepatitis C virus
- •Pregnant or lactating
研究组 & 干预措施
IMC-001
Experimental
干预措施: IMC-001 (Drug)
结局指标
主要结局
ORR
时间窗: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Percentage of participants achieving a best overall response (BOR) of CR or PR by centralized independent review using RECIST 1.1 criteria.
次要结局
- Evaluate additional efficacy variables of IMC-001 : Immune duration of response (iDOR)(Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).)
- Evaluate additional efficacy variables of IMC-001(through study completion, an average of 1 year)
- Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS)(Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).)
- Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR)(Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).)
- Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP)(Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).)
- Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR)(Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).)
- Evaluate additional efficacy variables of IMC-001 : Objective Response Rate (ORR)(Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).)
- Evaluate additional efficacy variables of IMC-001 : Immune progression-free survival (iPFS)(Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).)
- Evaluate additional efficacy variables of IMC-001 : Immune objective response rate (iORR)(Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).)
- Survival Outcome : Overall Survival (OS)(through study completion, an average of 1 year)
- Evaluate the pharmacokinetic (PK) profile of IMC-001(through study completion, an average of 1 year)
- Characterize the immunogenicity of IMC-001(through study completion, an average of 1 year)
研究者
研究点 (4)
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