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
- 80
- 试验地点
- 10
- 主要终点
- 1. Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
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).
The study will enroll 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 will be conducted in two phases:
Part 1: Dose escalation phase
Part 2: Dose expansion phase
Dose escalation will continue until either the maximum tolerated dose (MTD) is defined, the maximum planned dose is reached, or a recommended phase 2 dose (RP2D) is selected. Dose expansion cohorts will be initiated to further confirm safety and optimal biologically active dose at each putative recommended Phase 2 dose(s). Participants will 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
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
1. Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
时间窗: 1. [Time Frame: Up to 18 months] | 2. [Time Frame: Up to 28 days]
2. 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: 1. [Time Frame: Up to 18 months] | 2. [Time Frame: Up to 28 days]
次要结局
- Time to Next Treatment (TTNT)([Time Frame: 18 months])
- Maximum Concentration (Cmax) of ISB 2001 in Serum([Time Frame: Up to 28 days])
- Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum([Time Frame: Up to 28 days])
- Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum([Time Frame: Up to 28 days])
- Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum([Time Frame: 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)([Time Frame: Baseline to 18 months])
- Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)([Time Frame: 18 months])
- Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)([Time Frame: 18 months])
- Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)([Time Frame: 18 months])
- Time to Progression (TTP)([Time Frame: 18 months])
- Time to Response (TTR)([Time Frame: 18 months])
- Progression Free Survival (PFS)([Time Frame: 18 months])
- Overall Survival (OS)([Time Frame: 18 months])
研究者
Dr. Veena Gupta
Glenmark Pharmaceuticals Ltd