NCT06508606

AK117 (Anti-CD47) + Anti-EGFR for R/M HNSCC

A Phase II Study of AK117 (Anti-CD47) Combined With Anti-EGFR in the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The administration of first-line pembrolizumab monotherapy or combined chemotherapy has been shown to improve survival among patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). However, over 80% of the patients still experience disease progression within a year. Upon progression, treatment options are notably constrained, typically comprising methotrexate, docetaxel, and cetuximab. The median progression-free survivaland overall survival following chemotherapy, targeted therapy, or their combination are dismally low, ranging from 2-3 months and 6-8 months, respectively. The clinical trials CheckMate 141 and KEYNOTE 040 have led to the approval of Nivolumab and Pembrolizumab as second-line treatments for R/M HNSCC. Nevertheless, the response rates to immune monotherapy are limited, ranging from 10% to 35%. Even after receiving standard second-line immunotherapy, over 80% of patients encounter disease progression within 6 months, and more than 60% succumb to the disease within a year. Therefore, there is a dearth of a standardized treatment for R/M HNSCC after the failure of first- or second-line PD-1 (L1) inhibitors and/or platinum-based therapy

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	AK117	AK117: 45mg/kg (D1, IVGTT, Q3W maintained for one year or until progression or intolerable toxicity occurred
DRUG	anti-EGFR	anti-EGFR:initial dose 400mg/m2, subsequent doses of 250mg/m2, D1, QW) maintained for one year or until progression or intolerable toxicity occurred

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2024-07-18
• Last updated: 2024-07-19