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

Launched by AKESO · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AK135 for patients who have developed nerve damage, known as chemotherapy-induced peripheral neuropathy (CIPN), as a result of cancer treatment. The trial aims to find out whether AK135 is safe to use, how well it is tolerated by patients, and if it can help relieve symptoms like pain and numbness caused by CIPN. It is designed for adults between the ages of 65 and 74, and anyone aged 27 to 93, and is currently not yet recruiting participants.

To be eligible for this study, participants need to provide written consent, have a specific type of cancer, and show signs of CIPN that are affecting their quality of life. They must have stopped any prior cancer treatments that caused nerve damage for at least a month before joining the trial. Participants can expect to receive AK135 and will be monitored closely for safety and effectiveness. It’s important to note that individuals with certain other health issues or ongoing cancer treatments may not be able to participate. Overall, this trial hopes to find a new way to help patients suffering from painful nerve symptoms after chemotherapy.

Gender

ALL

Eligibility criteria

• 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.