A Phase I, Open-label, Multicenter, Study of WVT078 in Subjects With Relapsed and/or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Incidence of dose limiting toxicity (DLTs) in Cycle 1
研究概览
简要总结
The design of a phase I, open-label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent WVT078 alone and in combination with WHG626 in patients relapses and/or refractory Multiple Myeloma (MM)
详细描述
This first-in-human trial with WVT078 is a dose escalation study whose primary purpose is to characterize the safety, tolerability, and determine recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with MM who have received two or more standard of care lines of therapy including an IMID, a proteasome inhibitor, and an anti-CD38 agent (if available) and are relapsed and/or refractory to or intolerant of each regimen. In addition, this study will assess preliminary anti-MM response of and characterize the pharmacokinetics and immunogenicity of WVT078 alone and in combination with WHG626. The results of this study will inform the future development of WVT078 alone and in combination with WHG626 as a treatment for relapsed and/or refractory MM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are relapsed and/or refractory to two or more regimens including an IMID, proteasome inhibitor, and an anti-CD38 agent (if available)
排除标准
- •Use of systemic chronic steroid therapy (>or= 10mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment
- •Malignant disease other than being treated on this study
- •Active known or suspected autoimmune disease
- •Impaired cardiac function or clinically significant cardiac disease
- •Treatment with cytotoxic or small molecule antineoplastics or any experimental therapy within 14 days or 5 half-lives whichever is shorter
- •Active central nervous system involvement by malignancy or presence of symptomatic CNS metasteses
研究组 & 干预措施
WVT078 in Multiple Myeloma (MM) patients
Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)
干预措施: WVT078 (Biological)
WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients
Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)
干预措施: WVT078 (Biological)
WVT078 in combination with WHG626 in Multiple Myeloma (MM) patients
Dose escalation study to determine Maximum Tolerated Dose (MTD)/ Recommended Dose (RD) in adult patients with relapsed and/or refractory Multiple Myeloma (MM)
干预措施: WHG626 (Drug)
结局指标
主要结局
Incidence of dose limiting toxicity (DLTs) in Cycle 1
时间窗: 28 days (first cycle)
To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM
Frequency of dose interruptions
时间窗: Up to 28 months
To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM
Frequency of discontinuations
时间窗: up to 28 months
To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, ECGs, and CRS/immune-mediated reactions
时间窗: Up to 31 months
To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM
Frequency of dose reductions
时间窗: up to 28 months
To characterize the safety, tolerability, and determine the recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with relapsed and/or refractory MM
次要结局
- Tmax of WVT078 derived from serum concentrations(Up to 28 months)
- AUC of WVT078 derived from serum concentrations(Up to 28 months)
- Cmin of WVT078 derived from serum concentrations(Up to 28 months)
- Concentration of WVT078 Anti Drug Antibodies (ADA) as measured in serum(Up to 28 months)
- Duration of Response (DOR)(Up to 36 months)
- Progresson Free Survival (PFS)(Up to 36 months)
- Cmax of WVT078 derived from serum concentrations(Up to 28 months)
- AUC of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations(Up to 28 months)
- Best Overall Response (BOR)(Up to 36 months)
- T1/2 of WVT078 derived from serum concentrations(Up to 28 months)
- AUC of WHG626 derived from plasma concentrations(Up to 28 months)
- T1/2 of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations(Up to 28 months)
- Cmin of GWQ573 (the active metabolite of WHG626) devived from plasma concentrations(Up to 28 months)
- Cmax of WHG626 derived from plasma concentrations(Up to 28 months)
- Cmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations(Up to 28 months)
- Cmin of WHG626 derived from plasma concentrations(Up to 28 months)
- Tmax of WHG626 derived from plasma concentrations(Up to 28 months)
- T1/2 of WHG626 derived from plasma concentrations(Up to 28 months)
- Tmax of GWQ573 (the active metabolite of WHG626) derived from plasma concentrations(Up to 28 months)