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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
IV infusion, specified dose with specified treatment frequency
Sun Yat-sen Memorial Hospital
Guangzhou, China
Shanghai GoBroad Cancer Hospital
Shanghai, China
Adverse events
Incidence and severity of participants with adverse events
Time frame: From time ICF is signed until 90 days after last dose of AK135
DLT
Time frame: During the first treatment cycle of AK135 (14 days)
EORTC-QLQ-CIPN20
Patient-assessed European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale
Time frame: through study completion, an average of 12 weeks
BPI-SF
Patient-assessed Brief Pain Inventory-Short Form
Time frame: through study completion, an average of 12 weeks
CTCAE-Neuropathy
Physician-assessed Common Terminology Criteria for Adverse Events-Neurotoxicity
Time frame: through study completion, an average of 12 weeks
Cmax of AK135
Time frame: through study completion, an average of 12 weeks
AUC
Time frame: through study completion, an average of 12 weeks
t1/2
Time frame: through study completion, an average of 12 weeks
ADAs
Number of subjects who develop detectable anti-drug antibodies
Time frame: From first dose of study drug through 30 days after last dose of study drug.
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