AK135 in Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
AK135
DrugIV infusion, specified dose with specified treatment frequency
Treatment groups
85 Participants
are divided into 1 treatment groupGroup A: AK135Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events
Incidence and severity of participants with adverse events
Time frame
From time ICF is signed until 90 days after last dose of AK1352
DLT
Time frame
During the first treatment cycle of AK135 （14 days）Secondary outcomes
1
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 weeks2
BPI-SF
Patient-assessed Brief Pain Inventory-Short Form
Time frame
through study completion, an average of 12 weeks3
CTCAE-Neuropathy
Physician-assessed Common Terminology Criteria for Adverse Events-Neurotoxicity
Time frame
through study completion, an average of 12 weeks4
Cmax of AK135
Time frame
through study completion, an average of 12 weeks Source ClinicalTrials.gov
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