AK135 in Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Официальное название

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

Обзор

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

Вмешательства

• Препарат AK135
  IV infusion, specified dose with specified treatment frequency

Первичные конечные точки

• Adverse events [Срок оценки: From time ICF is signed until 90 days after last dose of AK135]
• DLT [Срок оценки: During the first treatment cycle of AK135 （14 days）]

Вторичные конечные точки (7)

• EORTC-QLQ-CIPN20 [Срок оценки: through study completion, an average of 12 weeks]
• BPI-SF [Срок оценки: through study completion, an average of 12 weeks]
• CTCAE-Neuropathy [Срок оценки: through study completion, an average of 12 weeks]
• Cmax of AK135 [Срок оценки: through study completion, an average of 12 weeks]
• AUC [Срок оценки: through study completion, an average of 12 weeks]
• t1/2 [Срок оценки: through study completion, an average of 12 weeks]
• ADAs [Срок оценки: From first dose of study drug through 30 days after last dose of study drug.]

Критерии участия

Критерии включения

• Written and signed informed consent.
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
• 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.

Критерии исключения

• Pharmacologic or non-pharmacologic treatment for CIPN within 2 weeks before the first dose of AK135.
• 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 AK135.
• 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 AK135.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Sun Yat-sen Memorial Hospital — Гуанчжоу
• Shanghai GoBroad Cancer Hospital — Шанхай

Идентификаторы

NCT: NCT06860789 · AK135-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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