NCT06860789

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

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AK135 for the Treatment of Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Patients With Malignant Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	AK135	IV infusion, specified dose with specified treatment frequency

Timeline

• Start date: 2025-02-28
• Primary completion: 2026-03-31
• Completion: 2027-12-31
• First posted: 2025-03-06
• Last updated: 2025-03-06

Locations

2 sites across 1 country: China