NCT04830592

A Study of NG-641 and Pembrolizumab in Squamous Cell Carcinoma of the Head and Neck

A Multicentre, Open-label, Dose-escalating, Phase Ib, Study of Intravenous Dosing of NG-641, as Monotherapy or in Combination With Pembrolizumab in Patients With Surgically Resectable Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Akamis Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicentre, open-label, non-randomized, phase Ib neoadjuvant study of intravenous NG-641, as monotherapy or in combination with pembrolizumab, in patients with surgically resectable squamous cell carcinoma of the head and neck (SCCHN).

Detailed description

Part A (NG-641 monotherapy): Approximately 16 evaluable patients will receive three doses of IV NG-641 in Part A. Patients will then proceed to planned surgical resection. Part B (NG-641 and pembrolizumab): Up to 20 evaluable patients will receive three doses of IV NG-641 and one dose of pembrolizumab. Patients will then proceed to planned surgical resection.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	NG-641	Patients receive three doses of NG-641 by intravenous infusion. NG-641 is a replication competent adenoviral vector producing a bispecific T cell activator (TAc) targeting fibroblast activation protein (FAP) plus immune enhancer genes CXCL9/CXCL10/IFNa2. This can lead to killing of tumor cells and stimulation of immunity against the tumor cells.
BIOLOGICAL	Pembrolizumab	Patients receive three doses of NG-641 by intravenous infusion and a single dose of Pembrolizumab by intravenous infusion.

Timeline

• Start date: 2021-11-04
• Primary completion: 2023-12-07
• Completion: 2024-10-04
• First posted: 2021-04-05
• Last updated: 2025-03-24

Locations

4 sites across 1 country: United Kingdom