AK117 (Anti-CD47 mAb) Plus Cetuximab as Second-Line Therapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

StatusCompleted
PhasePhase 2
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 6 more changesShow less
    • Final enrollment: 10 participants (planned 20)
    • Primary completion date changed from estimate of Nov 1, 2026 to Aug 1, 2026
    • Interventions modified
    • Trial arms changed: 2 → 1
    • Eligibility criteria expanded, about 34 words
    • Study title shortened, about 4 words
  2. Enrollment increased: 10 → 20 participantsv3 Show 5 more changesShow less
    • Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Primary completion pushed from Aug 1, 2026 to Nov 1, 2026
    • Trial arms changed: 1 → 2
    • Interventions: AK117 (Drug), anti-EGFR (Drug) to AK117 + AK104 (Drug), AK117 + Cetuximab (Drug)
    • Study title expanded, about 13 words
  3. Interventions: AK117+ anti-EGFR (Drug) to AK117 (Drug), anti-EGFR (Drug)
    • Study title shortened, about 16 words
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06508606
Lead Sponsor West China Hospital
Conditions
(from sponsor)		 Head and Neck Squamous Cell Carcinoma
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov