An Open-Label, Multicenter, Phase 1 Study of IGM-7354 in Adult Participants With Relapsed and/or Refractory Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 5
- 主要终点
- To evaluate the safety and tolerability of IGM-7354 in participants with cancer including estimation of the MTD or MAD
研究概览
简要总结
This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to evaluate the safety, tolerability, and PK of IGM-7354 in participants with relapsed and/or refractory tumors. The study design consists of a dose-escalation stage and dose-expansion stage. Study participation will consist of a 28-day screening period, a treatment period, and a safety follow-up period 90-days after the last dose.
详细描述
Patients will be enrolled in two stages: a dose-escalation stage and an expansion stage. The escalation stage will investigate single agent IGM-7354 safety and tolerability in patients with relapsed and/or refractory solid tumors. The dose expansion serial biopsy cohort will assess the intra-tumoral PD changes related to the activity of IGM-7354.
IGM-7354 will be administered intravenously (IV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Age > 18 years at time of signing ICF
- •ECOG Performance Status of 0 or 1
- •Histologic or cytologic documentation of incurable, locally advanced or metastatic solid tumors for which standard therapies are not available, are no longer effective, are not tolerated, or have been declined by the participant
- •Participants with either measurable or evaluable disease
- •Adequate organ function
- •At least 2 weeks prior to Day 1 or 5 half-lives, whichever is shorter, must have elapsed from the use of anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy
- •Participants must be willing to have pre-treatment and on-treatment tumor biopsies for biomarker evaluation
排除标准
- •Inability to comply with study and follow-up procedures
- •Prior IL-15, IL-2, synthetic IL-2, or IL-2v based therapy
- •History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- •Palliative radiation to bone metastases within 2 weeks prior to Day 1
- •Major surgical procedure within 4 weeks prior to Day 1
- •Untreated or active central nervous system (CNS) metastases. Patients with a history of treated CNS metastases are eligible.
- •Active autoimmune disease that has required systemic treatment in the past 2 years.
- •Diagnosis of immunodeficiency
- •Current Grade >1 toxicity from prior therapy. Participants with current Grade 2 chronic toxicities that are well-controlled by medications may be enrolled after discussion with medical monitor
研究组 & 干预措施
IGM-7354 Single-Agent Dose Escalation
IGM-7354 will be administered intravenously as a single agent.
干预措施: IGM-7354 (Drug)
IGM-7354 Single-Agent Dose Expansion Serial Biopsy
IGM-7354 will be administered intravenously as a single agent and patients will undergo pre-treatment and on-treatment biopsies.
干预措施: IGM-7354 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of IGM-7354 in participants with cancer including estimation of the MTD or MAD
时间窗: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Incidence of treatment-emergent AEs, SAEs, and DLT per NCI CTCAE v5.0
次要结局
- Clearance (CL) of IGM-7354(At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days))
- Volume of distribution (V) of IGM-7354(At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days))
- Duration of Response (DoR)(Study duration of approximately 29 months)
- Anti-drug antibodies (ADAs) of IGM-7354(At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days))
- Area Under the Curve (AUC) of IGM-7354(At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days))
- Objective Response Rate (ORR)(Study duration of approximately 29 months)
- Maximum Plasma Concentration (Cmax) of IGM-7354(At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days))
- Progression-Free Survival (PFS)(Study duration of approximately 29 months)