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

Inclusion criteria

• 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.

Exclusion criteria

• 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.