AK135: IV infusion, specified dose with specified treatment frequency
Study summary
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Written and signed informed consent.
2. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
3. Life expectancy ≥ 3 months.
4. Histologically or cytologically documented malignant tumor.
5. Previous anti-tumor therapy causing peripheral neurotoxicity that has been discontinued for at least 1 month before enrollment.
6. Diagnosed with Chemotherapy-Induced Peripheral Neuropathy (CIPN) by an oncologist or neurologist, with at least grade 2 NCI Common Terminology Criteria for Adverse Events.
7. Must have pain and/or numbness due to chemotherapy-induced peripheral neuropathy (CIPN) symptoms.
8. Adequate organ function.
Exclusion Criteria:
1. Pharmacologic or non-pharmacologic treatment for CIPN within 2 weeks before the first dose of AK135.
2. 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.
3. 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.
4. 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.
5. Skin lesions may affect the assessment of peripheral neuropathy.
6. 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.
7. Known allergy or reaction to any component of the AK135 formulation. History of severe hypersensitivity reactions to other mAbs.
Primary outcome measure(s)
Adverse events — From time ICF is signed until 90 days after last dose of AK135 Incidence and severity of participants with adverse events
DLT — During the first treatment cycle of AK135 (14 days)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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