NCT03309111已完成1 期
A Phase 1, First-in-Human, Multicenter, Open-Label, Two-Part Dose-Escalation and Cohort Expansion Study of Single-Agent ISB 1342 in Subjects With Previously Treated Multiple Myeloma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 37
- 主要终点
- Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1)
研究概览
简要总结
The purpose of this study is to assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic (PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma.
详细描述
This study is an open-label, multi-center, Phase 1 study of ISB 1342 in subjects with relapsed/refractory multiple myeloma refractory to proteasome inhibitors (PIs), immunomodulators (IMiDs), and daratumumab. There will be a dose escalation phase (Part 1) and dose expansion phase (Part 2). In Part 1 of the study, subjects will be treated at escalating dose levels. Once the recommended part 2 dose (RP2D) of ISB 1342 is declared in Part 1, the expansion phase (Part 2) will be initiated at the RP2D.
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
- •Documented diagnosis of multiple myeloma with measurable disease (serum, urine, or free light chain) per International Myeloma Working Group (IMWG) criteria, including non-secretory or oligo-secretory multiple myeloma which has relapsed after or is refractory to prior therapies, including proteasome inhibitors (PIs), immunomodulators (IMiDs) and anti-CD38 targeted therapies (daratumumab, isatuximab).
- •Eastern Cooperative Oncology Group (ECOG) performance-status score of 2 or less and 1 or less (for France).
- •Adequate hematologic, renal, and hepatic functions
- •Seronegative for hepatitis B antigen; positive hepatitis B tests can be further evaluated by confirmatory tests, and if viral load is negative, the subject can be enrolled.
- •Seronegative for hepatitis C antibody; if positive, then further test for the presence of antigen by hepatitis C virus polymerase chain reaction (HCV PCR). If HCV antigen tests are negative, then the subject can be enrolled.
- •Oxygen saturation level ≥92% on room air.
- •Left ventricular ejection fraction (LVEF) ≥50% and no pericardial or pleural effusion at Screening
排除标准
- •Active central nervous system involvement
- •Exposure to daratumumab or isatuximab within 2 months prior to the start of study treatment
- •Active plasma cell leukemia
- •Active infectious disease
- •Clinically significant cardiovascular and respiratory conditions
- •History of HIV infection
- •Subjects requiring prohibited concomitant medications
结局指标
主要结局
Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1)
时间窗: 28 days
Proportion of subjects with an investigator-assessed objective response (at least a partial response or better), complete response, disease control (stable disease or better) to ISB 1342, per International Myeloma Working Group (IMWG) criteria (Part 2)
时间窗: 28 days
次要结局
- Efficacy of ISB 1342 (duration of response [DOR]) (Part 1 and Part 2)(28 days)
- Efficacy of ISB 1342 (time to treatment failure [TTF]) (Part 2)(28 days)
- Proportion of subjects with investigator-assessed objective response (at least a partial response or better), complete response, disease control (stable disease or better) to ISB 1342, per International Myeloma Working Group (IMWG) criteria (Part 1)(28 days)
- Percent incidence of neutralizing antibody formation from positive anti-drug antibody (ADA) samples assessed from baseline until end of treatment (EOT) (Part 1 and Part 2)(28 days)
- Efficacy of ISB 1342 (time to disease progression [TTP]) (Part 2)(28 days)
- Efficacy of ISB 1342 (disease control rate [DCR]) (Part 1 and Part 2)(28 days)
- Efficacy of ISB 1342 (time to minimal residual disease [MRD] negative status) (Part 1 and Part 2)(28 days)
- Maximum serum concentration (Cmax) of ISB 1342 (Part 1 and Part 2)(28 days)
- Time to reach maximum observed plasma concentration (Tmax) of ISB 1342 (Part 1 and Part 2)(28 days)
- Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation (Part 1 and Part 2)(28 days)
- Efficacy of ISB 1342 (duration of disease control) (Part 1 and Part 2)(28 days)
- Number of subjects with adverse events based on frequency and severity as assessed by common terminology criteria for adverse events (CTCAE) v5.0 (Part 1 and Part 2)(up to 30 days post last dose)
- Area under the serum concentration time curve from zero to time t (AUC0-t) of ISB 1342 (Part 1 and Part 2)(28 days)
- Area under the curve from time zero to end of dosing interval (AUC0-tau) of ISB 1342 (Part 1 and Part 2)(28 days)
- Efficacy of ISB 1342 (progression free survival [PFS]) (Part 2)(28 days)
- Efficacy of ISB 1342 (overall survival [OS]) (Part 2)(Time from first dose until death from any cause or end of study collection, whichever is later, assessed up to 60 months.)
研究者
研究点 (37)
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