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

NCT06860789 | Not Yet Recruiting Phase 1

• 1 other identifier: AK135-101
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

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

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Outcome Measures

Primary Outcomes (2)

• Adverse events

  Incidence and severity of participants with adverse events

  From time ICF is signed until 90 days after last dose of AK135

• DLT

  During the first treatment cycle of AK135 （14 days）

Secondary Outcomes (7)

• EORTC-QLQ-CIPN20

  through study completion, an average of 12 weeks

• BPI-SF

  through study completion, an average of 12 weeks

• CTCAE-Neuropathy

  through study completion, an average of 12 weeks

• Cmax of AK135

  through study completion, an average of 12 weeks

• AUC

  through study completion, an average of 12 weeks

Study Arms (1)

AK135

EXPERIMENTAL

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).

Drug: AK135

Interventions

AK135 DRUG

IV infusion, specified dose with specified treatment frequency

AK135

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Previous anti-tumor therapy causing peripheral neurotoxicity that has been discontinued for at least 1 month before enrollment.
• Diagnosed with Chemotherapy-Induced Peripheral Neuropathy (CIPN) by an oncologist or neurologist, with at least grade 2 NCI Common Terminology Criteria for Adverse Events.
• Must have pain and/or numbness due to chemotherapy-induced peripheral neuropathy (CIPN) symptoms.
• Adequate organ function.

You may not qualify if:

• 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.
• Skin lesions may affect the assessment of peripheral neuropathy.
• Known allergy or reaction to any component of the AK135 formulation. History of severe hypersensitivity reactions to other mAbs.

Sponsors & Collaborators

• Akeso: lead

Study Sites (2)

Sun Yat-sen Memorial Hospital

Guangzhou, China

Location

Shanghai GoBroad Cancer Hospital

Shanghai, China

Location

Central Study Contacts

Xufang Yu

CONTACT

+86(0760)8987399; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 6, 2025
• Study Start: February 28, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 6, 2025

Record last verified: 2025-02

Locations

CN (2)