Chemotherapy-induced Peripheral Neuropathy (CIPN)
Conditions
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
Interventions
DRUGAK135
IV infusion, specified dose with specified treatment frequency
Sponsors
Akeso
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
| 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 |
| AUC | through study completion, an average of 12 weeks | — |
| BPI-SF | through study completion, an average of 12 weeks | Patient-assessed Brief Pain Inventory-Short Form |
Countries
China
Contacts
Primary ContactXufang Yu
Outcome results
None listed