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

Phase 1

Not yet recruiting

• Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)
• Interventions: Drug: AK135

• Registration Number: NCT06860789
• Lead Sponsor: Akeso

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-25
• Study Start: 2025-02-28
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2026-03-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
AK135	AK135	Each subject will receive a single dose of AK135 every 2-week cycle (Q2W) or every 1-week cycle (QW) or every 3-week cycle (Q3W).

Primary Outcome Measures

Name	Time	Method
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）

Secondary Outcome Measures

Name	Time	Method
EORTC-QLQ-CIPN20	through study completion, an average of 12 weeks	Patient-assessed European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale
BPI-SF	through study completion, an average of 12 weeks	Patient-assessed Brief Pain Inventory-Short Form
CTCAE-Neuropathy	through study completion, an average of 12 weeks	Physician-assessed Common Terminology Criteria for Adverse Events-Neurotoxicity
Cmax of AK135	through study completion, an average of 12 weeks
AUC	through study completion, an average of 12 weeks
t1/2	through study completion, an average of 12 weeks
ADAs	From first dose of study drug through 30 days after last dose of study drug.	Number of subjects who develop detectable anti-drug antibodies

Trial Locations

Locations (2)

Sun Yat-sen Memorial Hospital; 🇨🇳 Guangzhou, China

Shanghai GoBroad Cancer Hospital; 🇨🇳 Shanghai, China