AK135 in Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AK135
Treatment groups
85 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov