20Oct 2024
Phase 1b Trial: Limited Efficacy for FAP-IL2v and Cetuximab in HNSCC

Phase 1b Trial: Limited Efficacy for FAP-IL2v and Cetuximab in HNSCC

A phase 1b clinical trial assessed the combination of FAP-IL2v, a novel immune-cytokine, and cetuximab in patients with recurrent, unresectable, or metastatic head and neck squamous cell carcinoma (HNSCC). Fifty-eight patients participated, with 19 in dose-escalation and 39 in the expansion phase. The maximum tolerated dose (MTD) of FAP-IL2v was determined to be 10 mg (QW/Q2W), alongside cetuximab (500 mg/m², Q2W). While the combination demonstrated a favorable safety profile and expanded intratumoral NK and CD8 T cells, the antitumor activity was low, with a 7% objective response rate. This limited efficacy suggests further exploration in HNSCC may not be warranted.

  • #pharmacology
  • #oncology

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