An Open-Label, Multicenter, Phase 1 Study of IGM-2644 in Participants With Relapsed and/or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 5
- 主要终点
- To evaluate the safety and tolerability of IGM-2644 in participants with multiple myeloma, including estimation of the maximum tolerated dose (MTD) or maximum administered dose (MAD)
研究概览
简要总结
This is a first in human, phase 1, multicenter, open-label study to determine the safety and tolerability of IGM-2644 as a single agent in participants with relapsed and/or refractory MM, for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate. Dose escalation and dose expansion cohorts will be enrolled to evaluate safety, preliminary efficacy, and further define a RP2D. The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 60 months.
详细描述
Patients will be enrolled in two stages: a dose-escalation stage and a dose expansion stage. The escalation stage will investigate single agent IGM-2644 safety and tolerability in patients with relapsed and/or refractory multiple myeloma. The dose expansion cohort(s) will further evaluate safety, PK/PD, and preliminary efficacy of the recommended phase 2 dose (RP2D).
IGM-2644 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
- •Adults > 18 years at time of consent
- •ECOG performance status of 0 or 1
- •Relapsed and/or refractory multiple myeloma after ≥ 3 prior lines; Must have failed treatment with an IMiD, PI, and anti-CD38 therapy
- •Measurable disease per the IMWG response criteria
- •Adequate marrow and organ function without transfusion or growth factor support within 7 days prior to screening
- •Willing and able to undergo bone marrow aspirate and biopsy per protocol
排除标准
- •Inability to comply with study and follow-up procedures
- •History of clinically significant primary amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia or myelodysplastic syndrome
- •Received chemotherapy, biologics, or small molecule therapy within 21 days or 5 half-lives, whichever is shorter
- •Use of any non-approved or investigational agent ≤ 4 weeks prior to the first dose of study drug.
- •Received last prior anti-CD38 monoclonal antibody treatment within 28 days before first planned dose of the study drug
- •Current Grade > 1 toxicity, with the exception of Grade 2 peripheral neuropathy, alopecia, or toxicities from prior anti-tumor therapy that are considered irreversible
- •Large-field radiotherapy within 28 days prior to Day 1 (radiation to a single site as concurrent therapy is allowed)
- •Prior autologous stem cell transplant within 180 days prior to Day 1
- •Prior allogeneic stem cell transplant
研究组 & 干预措施
IGM-2644 Dose Escalation
Participants will receive IGM-2644 via intravenous (IV) infusion weekly.
干预措施: IGM-2644 (Drug)
IGM-2644 Dose Expansion
Participants will receive IGM-2644 via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data.
干预措施: IGM-2644 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of IGM-2644 in participants with multiple myeloma, including estimation of the maximum tolerated dose (MTD) or maximum administered dose (MAD)
时间窗: From Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Incidence of treatment-emergent AEs, SAEs, and DLT per NCI CTCAE v5.0
次要结局
- Clearance (CL) of IGM-2644(At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days))
- Anti-Drug Antibodies (ADA) Formation(At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days))
- Area Under the Curve (AUC) of IGM-2644(At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days))
- Half Life (HL) of IGM-2644(At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days))
- Maximum Plasma Concentration (Cmax) of IGM-2644(At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days))
- Objective Response Rate (ORR)(At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months)
- Progression Free Survival (PFS)(At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months)
- Duration of Response (DoR)(At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months)