NCT07138196招募中1 期
A Phase 1b, Open-label Dose Escalation Study to Evaluate the Safety, Pharmacodynamic, Pharmacokinetic and Preliminary Efficacy of Q702 in Subjects With Relapsed or Refractory Active Chronic Graft-versus-Host Disease (cGVHD)
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 8
- 主要终点
- Number of Participants with Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
Open-label, dose escalation study to evaluate safety, tolerability pharmacokinetic and pharmacodynamic activity, and efficacy of Adrixetinib (Q702) in subjects with relapsed or refractory active chronic graft-versus-host disease (cGVHD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Subjects who are allogeneic HSCT recipients with moderate or severe active cGVHD requiring systemic immune suppression.
- •Subjects with relapsed or refractory active cGVHD who have progressed after all available standard of care treatments.
- •Subject must have documented progressive disease as defined by the NIH 2014 consensus criteria, in terms of either organ specific algorithm or global assessment, or active, symptomatic cGVHD for which the treating physician believes that a new line of systemic therapy is required.
- •Adequate organ and bone marrow functions.
- •Karnofsky Performance Scale of ≥ 60.
排除标准
- •Exposure to CSF1R inhibitor therapy for any indication after allogeneic transplant.
- •Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer.
- •Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of enrollment.
- •Female subject who is pregnant or breastfeeding.
- •Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
研究组 & 干预措施
Adrixetinib (Q702)
Experimental
Escalating doses of adrixetinib in 28 day cycles.
干预措施: Adrixetinib (Drug)
结局指标
主要结局
Number of Participants with Dose-Limiting Toxicities (DLTs)
时间窗: Cycle 1 (28 Days)
DLTs assessed for each dose level
Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)
时间窗: Cycle 1 (28 Days)
AEs and SAEs assessed for each dose level.
次要结局
- Pharmacokinetics (PK)(Estimated up to Cycle 1 (28 Days))
研究者
研究点 (8)
Loading locations...
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