NCT04975399终止1 期
A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-92328 in Subjects With Relapsed and/or Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 26
- 试验地点
- 15
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This Phase 1, first-in-human (FIH), clinical study of CC-92328 will explore the safety, tolerability and preliminary biological and clinical activity of CC-92328 as a single-agent in the setting of relapsed and/or refractory multiple myeloma (R/R MM). The study will be conducted in two parts: monotherapy dose escalation (Part A) and monotherapy dose expansion (Part B).
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
- •Participants must satisfy the following criteria to be enrolled in the study:
- •must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
- •willing and able to adhere to the study visit schedule and other protocol requirements.
- •Participant is ≥ 18 years of age the time of signing the ICF.
- •Participant has a history of multiple myeloma (MM) with relapsed and/or refractory disease who have failed or who are ineligible or intolerant to available therapies that may provide clinical benefit.
- •Have documented disease progression on or within 12 months from the last dose of their last myeloma therapy.
- •Participant must have measurable disease.
- •Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or
- •Females of childbearing potential (FCBP) must commit to true abstinence from heterosexual contact or agree to use at least one method of highly effective contraception without interruption from screening to at least 12 weeks after the last dose of CC-92328
- •Males must practice true abstinence or agree to use a condom
- •FCBP and males must avoid conceiving from signing the ICF, while participating in the study, during dose interruptions, and for at least 12 weeks after the last dose of CC-92328.
排除标准
- •The presence of any of the following will exclude a participant from enrollment:
- •Participant has symptomatic central nervous system involvement of MM.
- •Participant had a prior autologous stem cell transplant ≤ 90 days prior to starting CC-
- •Participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior to starting CC-
- •Participant had prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting CC-92328, whichever is shorter.
- •Participant is a pregnant or lactating female.
- •Participant received live virus vaccines within at least 4 weeks prior to starting study drug.
- •Participant has known active human immunodeficiency virus (HIV) infection.
- •Participant has active hepatitis B or C (HBV/HCV) infection.
- •Participant weight is ≤ 40 kg at screening.
研究组 & 干预措施
Administration of CC-92328
Experimental
CC-92328 administered intravenously in 28-day cycles
干预措施: CC-92328 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: Up to 12 weeks after the last dose
Defined as the highest dose at which less than 33% of the population treated with CC-92328 experience a dose-limiting toxicity (DLT) in the first cycle and at least 6 evaluable participants have been treated at this dose level.
Incidence of Adverse Events (AEs)
时间窗: Up to 12 weeks after the last dose
Type, frequency, seriousness, severity and relationship of AEs to CC-92328.
Dose-Limiting Toxicities (DLTs)
时间窗: Up to 28 days after the first dose
Are defined as toxicities that meet the protocol-specified criteria occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to the underlying disease or extraneous causes.
次要结局
- Pharmacokinetics - Cmax(Day 1 to 9 weeks after last dose of study drug)
- Pharmacokinetics - t1/2(Day 1 to 9 weeks after last dose of study drug)
- Frequency of Anti-CC92328 antibodies (ADA)(Day 1 to 9 weeks after last dose of study drug)
- Preliminary Efficacy - Time to response(Up to approximately 2 years)
- Preliminary Efficacy - Duration of response(Up to approximately 2 years)
- Preliminary Efficacy - Overall Survival (OS)(Up to approximately 2 years)
- Pharmacokinetics - CL(Day 1 to 9 weeks after last dose of study drug)
- Pharmacokinetics - Vd(Day 1 to 9 weeks after last dose of study drug)
- Presence of Anti-CC92328 antibodies (ADA)(Day 1 to 9 weeks after last dose of study drug)
- Preliminary Efficacy - Overall Response Rate (ORR)(Up to approximately 2 years)
- Preliminary Efficacy - Progression-free Survival (PFS)(Up to approximately 2 years)
- Pharmacokinetics - tmax(Day 1 to 9 weeks after last dose of study drug)
- Pharmacokinetics - AUC(Day 1 to 9 weeks after last dose of study drug)
- Pharmacokinetics - Cmin(Day 1 to 9 weeks after last dose of study drug)
- Pharmacokinetics - Accumulation index of CC-92328(Day 1 to 9 weeks after last dose of study drug)
研究者
研究点 (15)
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