NCT06919666

NT219 Combined With Standard of Care Biologic Therapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Phase Ib/II Study of NT219 in Combination With Pembrolizumab or Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Fixed dose NT219 weekly plus pembrolizumab every 3 weeks or cetuximab weekly to be continued until progression, unacceptable toxicity, or investigator or participant decision.

Conditions

• Head and Neck Cancer
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	NT219	NT219 is a first-in-class small molecule targeting IRS 1/2 and STAT3. Preclinical studies in melanoma have shown NT219 induces PD-L1 expression in vitro and in vivo, resulting in increased efficacy of PD-1 inhibition via synergistic antitumor effect in PD-1 sensitive models and restoration of sensitivity in resistant models. NT219 also synergized with cetuximab in vitro and reversed cetuximab resistance in a head and neck cancer xenograft platform.

Timeline

• Start date: 2025-06-12
• Primary completion: 2030-02-01
• Completion: 2031-02-01
• First posted: 2025-04-09
• Last updated: 2026-04-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study