NCT01432353已完成1 期
An Open-label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DFRF4539A in Patients With Relapsed 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
- 已完成
- 入组人数
- 39
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This multicenter, open-label, dose-escalating study will assess the safety and efficacy of DFRF4539A in patients with relapsed or refractory multiple myeloma. Cohorts of patients will receive multiple ascending doses of intravenous DFRF4539A every 3 weeks or weekly. Patients exhibiting acceptable safety and evidence of clinical benefit may receive DFRF4539A for up to 17 cycles. Anticipated time on study treatment is 1 year or until disease progression or unacceptable toxicity occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Adult patients; >/= 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- •Relapsed or refractory multiple myeloma for which no effective standard therapy exists
- •One of the prior therapies must have included a proteosome inhibitor or an immunomodulatory drug
- •Measurable disease as defined by protocol
排除标准
- •Prior use of monoclonal antibody within 4 weeks before Cycle 1, Day 1
- •Treatment with radiotherapy, thalidomide, lenalidomide, bortezomib, any chemotherapeutic agent, or treatment with any investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1
- •Toxicities from any previous treatment must be resolved prior to Cycle 1, Day 1, except for neuropathy
- •Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1
- •Prior allogeneic stem cell transplant
- •History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
- •Grade > 1 peripheral neuropathy
- •Active infection at screening or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to Cycle 1, Day 1
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Pregnant or lactating women or women who intend to become pregnant within the period of time of this study
研究组 & 干预措施
Single Arm
Experimental
干预措施: DFRF4539A (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: approximately 3.5 years
Safety: Maximum tolerated dose/dose-limiting toxicities
时间窗: approximately 1.5 years
Recommended Phase II dose for every-3-week or weekly administration of DFRF4539A
时间窗: approximately 3.5 years
次要结局
- Immunogenicity: Serum antitherapeutic antibody levels(approximately 3.5 years)
- Duration of objective response, defined as time from first documented objective response to progression or death of any cause(approximately 3.5 years)
- Pharmacokinetics: Area under the concentration - time curve (AUC)(approximately 3.5 years)
- Objective response, tumor assessments according to International Myeloma Working Group (IMWG) Uniform Response Criteria and/or European Bone Marrow Transplant (EBMT) Criteria(approximately 3.5 years)
- Progression-free survival, defined as time from first study treatment (Cycle 1, Day 1) to disease progression or death during study or within 30 days after last dose of study drug, whichever occurs first(approximately 3.5 years)
研究者
相似试验
招募中
1 期
A Phase I Trial to Evaluate the Safety of IMC002 in Advanced Digestive System TumorsAdvanced Digestive System TumorNCT05946226Suzhou Immunofoco Biotechnology Co., Ltd18
已完成
1 期
Dose-escalation Study to Investigate the Safety, PK, and PD of ISU304/CB2679d in Hemophilia B PatientsHemophilia BNCT03186677ISU Abxis Co., Ltd.11
进行中（未招募）
1 期
A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or LymphomasSolid Malignancies or LymphomasNCT05290597Innovent Biologics (Suzhou) Co. Ltd.40
已完成
1 期
Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies SubjectsHematological MalignanciesNCT04283097Kangpu Biopharmaceuticals, Ltd.30
已完成
1 期
Dose Escalation Study to Assess the Safety and Tolerability of Genz-644282 in Patients With Solid TumorsSolid TumorsNCT00942799Genzyme, a Sanofi Company87