A First-in-Human, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Occurrence of dose-limiting toxicities (DLT)
研究概览
简要总结
This is the first-in-human, Phase I, open-label, multiple-ascending dose study to investigate the safety, tolerability, PK, PharmDyn, and clinical activity of IMC-002 in subjects with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas.
Male or female subjects 18 years and older with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas will be included in the study if they meet all the inclusion criteria and none of the exclusion criteria.
The study will consist of 2 parts:
Part 1: Dose Escalation Part 2: Expansion Cohorts
详细描述
Part 1: Dose Escalation
Part 2: Expansion Cohort The study may be amended in the future to include expansion cohorts in selected tumor types to further evaluate extended safety of IMC-002 at recommended Phase 2 dose in that tumor type. Sample size in the Dose Expansion part will be determined when the study is amended to include the expansion cohorts.
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 are eligible to be included in the study only if all of the following criteria apply:
- •Signed informed consent form (ICF)
- •Adult (18 years or older)
- •Histologically or cytologically proven metastatic or locally advanced solid tumors and relapsed or refractory lymphomas, for which no standard therapy known to prolong survival exists or have relapsed/refractory/PD following the last line of treatment
- •Solid tumors must be measurable with at least 1 unidimensional measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Lymphomas must have at least 1 measurable lesion according to the Lugano criteria with the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) modification
- •Availability of tumor archival material or fresh biopsies for measurement of CD47
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening and an estimated life expectancy of at least 3 months
- •Adequate hematologic function, hepatic function, and renal function
排除标准
- •Subjects are excluded from the study if any of the following criteria apply:
- •Treatment with nonpermitted drugs (within 28 days before Day 1).
- •Prior treatment with a CD47 or SIRPα targeting agent
- •Concurrent anticancer treatments within 28 days before Day 1/first study treatment administration
- •Major surgery or significant traumatic injury within 6 weeks prior to Screening or planned major surgery during the study period
- •Previous malignant disease other than the target malignancy for this study, except adequately treated Stage I or II cancers from which the subject is currently in complete remission per the Investigator's clinical judgment
- •Primary central nervous system (CNS) disease or leptomeningeal disease; known CNS metastases unless treated
- •Comorbidities/medical history of any significant diseases that in the judgment of the Investigator would make the subject inappropriate for this study
- •Active infection requiring systemic therapy within 14 days before Day 1
- •Persisting toxicities Grade > 1 NCI-CTCAE Version 5.0 related to prior anticancer treatment
- •Pregnant or lactating
研究组 & 干预措施
IMC-002
Dose escalation will follow the traditional 3+3 design.
干预措施: IMC-002 (Biological)
结局指标
主要结局
Occurrence of dose-limiting toxicities (DLT)
时间窗: For 28 days
Incidence and severity of adverse events (AEs)
时间窗: 2 years
次要结局
未报告次要终点