Clinical trial NCT06860789: AK135 in Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2025-03-06
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events
timeFrame: From time ICF is signed until 90 days after last dose of AK135
measure: DLT
timeFrame: During the first treatment cycle of AK135 （14 days）
Secondary outcomes:
measure: EORTC-QLQ-CIPN20
timeFrame: through study completion, an average of 12 weeks
measure: BPI-SF
timeFrame: through study completion, an average of 12 weeks
measure: CTCAE-Neuropathy
timeFrame: through study completion, an average of 12 weeks
measure: Cmax of AK135
timeFrame: through study completion, an average of 12 weeks
measure: AUC
timeFrame: through study completion, an average of 12 weeks
measure: t1/2
timeFrame: through study completion, an average of 12 weeks
measure: ADAs
timeFrame: From first dose of study drug through 30 days after last dose of study drug.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
city: Shanghai
country: China
facility: Shanghai GoBroad Cancer Hospital
Study officials:
References: