NCT06860789尚未招募1 期
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AK135 for the Treatment of Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Patients With Malignant Tumors
Akeso2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2025年2月28日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AK135 for the treatment of chemotherapy-induced peripheral neuropathy in patients with malignant tumor
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written and signed informed consent.
- •Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or
- •Life expectancy ≥ 3 months.
- •Histologically or cytologically documented malignant tumor.
- •Previous anti-tumor therapy causing peripheral neurotoxicity that has been discontinued for at least 1 month before enrollment.
- •Diagnosed with Chemotherapy-Induced Peripheral Neuropathy (CIPN) by an oncologist or neurologist, with at least grade 2 NCI Common Terminology Criteria for Adverse Events.
- •Must have pain and/or numbness due to chemotherapy-induced peripheral neuropathy (CIPN) symptoms.
- •Adequate organ function.
排除标准
- •Pharmacologic or non-pharmacologic treatment for CIPN within 2 weeks before the first dose of AK
- •Concurrent and/or scheduled to start any anti-tumor treatment that may cause Chemotherapy-Induced Peripheral Neuropathy (CIPN) within 3 months after the first dose of AK
- •Concurrent and/or scheduled to start any anti-tumor treatment that may cause hand-foot skin reaction within 3 months after the first dose of AK
- •Presence with other illnesses may result in peripheral neuropathy including, autoimmune diseases, diabetes and metabolic syndrome, peripheral vascular disease, infections, nerve injury or compression, vitamin deficiencies, and so on.
- •Skin lesions may affect the assessment of peripheral neuropathy.
- •Unresolved toxicities from prior anti-cancer therapy within 2 weeks before the first dose of AK135, defined as not having resolved to NCI CTCAE v5.0 Grade 0 or 1, or levels specified in the inclusion/exclusion criteria, except for alopecia, and neuropathy.
- •Known allergy or reaction to any component of the AK135 formulation. History of severe hypersensitivity reactions to other mAbs.
研究组 & 干预措施
AK135
Experimental
Each subject will receive a single dose of AK135 every 2-week cycle (Q2W) or every 1-week cycle (QW) or every 3-week cycle (Q3W).
干预措施: AK135 (Drug)
结局指标
主要结局
Adverse events
时间窗: From time ICF is signed until 90 days after last dose of AK135
Incidence and severity of participants with adverse events
DLT
时间窗: During the first treatment cycle of AK135 （14 days）
次要结局
- EORTC-QLQ-CIPN20(through study completion, an average of 12 weeks)
- BPI-SF(through study completion, an average of 12 weeks)
- CTCAE-Neuropathy(through study completion, an average of 12 weeks)
- Cmax of AK135(through study completion, an average of 12 weeks)
- AUC(through study completion, an average of 12 weeks)
- t1/2(through study completion, an average of 12 weeks)
- ADAs(From first dose of study drug through 30 days after last dose of study drug.)
研究者
研究点 (2)
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