A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- Safety and tolerability of 177Lu-IM-3050 in participants with advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs)
研究概览
简要总结
IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.
详细描述
IM-3050-101 is a 2-part Phase 1 first-in-human (FIH), open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, dosimetry, pharmacokinetics (PK), and preliminary anti-tumor activity of the radiopharmaceutical 177Lu-IM-3050 in participants with FAP-expressing advanced solid tumors. Part A of the study is a dose escalation phase to evaluate the safety, tolerability, preliminary anti-tumor activity, radiation dosimetry, and PK from escalating repeated doses of 177Lu-IM-3050 to determine maximum tolerated dose (MTD) and/or recommended expansion dose of 177Lu-IM-3050. Part B of the study is an expansion phase to further evaluate safety and tolerability of 177Lu-IM-3050 at the candidate recommended dose.
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
- •≥18 years of age
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1 or 2
- •Histological or cytological diagnosis of a solid tumor
- •Participants must be refractory to or have relapsed after at least one prior standard therapeutic regimen. Participants must be relapsed or refractory to, have developed an intolerance to, or not be candidates for available therapies with established benefit.
- •Participants must have measurable disease as per RECIST v.1.1 based on imaging performed during Screening.
- •During Part A only, participants without measurable disease per RECIST v1.1 are eligible if approved by Medical Monitor.
- •During screening, participants must have positive FAP PET/CT uptake as described in criteria for continuation of IM-3050 treatment.
- •Participants must have adequate organ function.
排除标准
- •Participant has received certain prior radiation therapy as detailed in the protocol
- •Participant has undergone major surgery within 4 weeks or minor surgery within 2 weeks of starting 177Lu-IM-3050 or has known active central nervous system (CNS) primary tumor or metastases and/or carcinomatous meningitis.
- •Participant has a known history of malignant primary brain tumor, or another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone potentially curative therapy with no evidence of that disease for at least 2 years and approved by the Medical Monitor.
- •Exception: The time requirement does not apply to participants who underwent successful definitive resection of certain cancers.
- •Recent or ongoing serious infection or other significant medical condition as detailed in the protocol.
- •Participant has received an investigational product or been treated with an investigational device within 30 days, or 5 half-lives prior to receiving the FAP PET/CT imaging tracer or 177Lu-IM-3050.
研究组 & 干预措施
Dose Escalation: 177Lu-IM-3050
177Lu-IM-3050 administered intravenously on a 6-week cycle
干预措施: 177Lu-IM-3050 (Drug)
Dose Expansion: 177Lu-IM-3050
177Lu-IM-3050 administered intravenously on a 6-week cycle
干预措施: 177Lu-IM-3050 (Drug)
结局指标
主要结局
Safety and tolerability of 177Lu-IM-3050 in participants with advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs)
时间窗: From first dose of 177Lu-IM-3050 through at least 42 days following last dose of study treatment serious; up to approximately 5 years
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 6.0, including adverse events (SAEs), AEs leading to discontinuation, and deaths
Determine the recommended dose of 177Lu-IM-3050 for further development
时间窗: From first dose of 177Lu-IM-3050 to 42 days following last dose of study treatment; up to approximately 5 years
Type, frequency, seriousness, and severity of AEs graded using the NCI-CTCAE criteria version 6.0, including SAEs, AEs leading to discontinuation, and deaths
Safety and tolerability of 177Lu-IM-3050 in participants with advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs)
时间窗: From first dose of 177Lu-IM-3050 through at least 42 days following last dose of study treatment serious and up to approximately 5 years
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0, including adverse events (SAEs), AEs leading to discontinuation, and deaths
Determine the recommended dose of 177Lu-IM-3050 for further development
时间窗: From first dose of 177Lu-IM-3050 to 42 days following last dose of study treatment and up to approximately 5 years
Type, frequency, seriousness, and severity of AEs graded using the NCI-CTCAE criteria version 5.0, including SAEs, AEs leading to discontinuation, and deaths
次要结局
- Safety and tolerability of FAP PET/CT imaging tracer in participants with advanced solid tumors as measured by incidence of TEAEs(From dose of FAP PET/CT imaging tracer until end of study)
- Time course of blood radioactivity of 177Lu-IM-3050(Through 42-49 days following last dose of 177Lu-IM-3050)
- Time course of plasma IM-3050(Through 42-49 days following last dose of 177Lu-IM-3050)
- Evaluate the preliminary anti-tumor activity of 177Lu-IM-3050 in participants with advanced solid tumors(Week 6 until disease progression or participant discontinuation from study)
- Evaluate the dosimetry of 177Lu-IM-3050 in participants with advanced solid tumors(From first dose of 177Lu-IM-3050 3050 in Cycle 1 up to 8 days after Cycle 3 (each cycle is 42 days) or until participant discontinuation, whichever is earlier)
- Safety and tolerability of FAP PET/CT imaging tracer in participants with advanced solid tumors as measured by incidence of TEAEs(From dose of FAP PET/CT imaging tracer to 72 hours after dose)