A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 33
- 主要终点
- Number of Dose-Limiting Toxicities (DLT) During the First 28 Days After the First Administration of ISB 2001 (Cycle 1) in Each Cohort (Part 1)
研究概览
简要总结
This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma (R/R MM).
详细描述
The study enrolls participants with R/R MM that have been treated with immunomodulatory drugs (IMiDs), proteasome inhibitors, and anti-CD38 therapies either in combination or as a single agent and are refractory to, or intolerant of, established therapies known to provide clinical benefit in MM.
The study is conducted in two parts: Part 1 dose escalation and Part 2 dose expansion.
Dose escalation continued until the maximum planned dose was reached. Dose expansion cohorts were initiated to further confirm safety and optimal biologically active dose. Participants receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 65+ years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
- •Must have adequate hematologic, hepatic, renal, and cardiac functions
排除标准
- •Active malignant central nervous system involvement
- •Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
- •History of autoimmune disease requiring systemic immunosuppressive therapy
- •Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study.
- •Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001.
研究组 & 干预措施
Part 1: Dose Escalation
Participants with R/R MM is administered ISB 2001 weekly on Days 1, 8, 15, and 22 of each 28-day cycle, with an additional step-up dose in Cycle 1 on Day 4. Treatment cycle duration is 28 days. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment or participant withdrawal from the study
干预措施: ISB 2001 (Drug)
Part 2: Dose Expansion
Dose expansion cohorts are initiated to further confirm safety and optimal biologically active dose. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment or participant withdrawal from the study.
干预措施: ISB 2001 (Drug)
结局指标
主要结局
Number of Dose-Limiting Toxicities (DLT) During the First 28 Days After the First Administration of ISB 2001 (Cycle 1) in Each Cohort (Part 1)
时间窗: Up to 28 days
Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to 18 months
次要结局
- Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum(Up to 28 days)
- Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)(18 months)
- Time to Next Treatment (TTNT)(18 months)
- Overall Survival (OS)(18 months)
- Time to Progression (TTP)(18 months)
- Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum(Up to 28 days)
- Percent Incidence of Anti-Drug Antibody (ADA), Neutralizing Antibody (nAb) and Titer of ADA From Baseline Until End-of-Treatment (EOT)(Baseline to 18 months)
- Maximum Concentration (Cmax) of ISB 2001 in Serum(Up to 28 days)
- Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum(Up to 28 days)
- Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)(18 months)
- Time to Response (TTR)(18 months)
- Progression Free Survival (PFS)(18 months)
- Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)(18 months)
研究者
Biologics Manufacturing/ Process Sciences entity
Scientific
IGI Therapeutics S.A.