RecruitingPhase 1Phase 2NCT06919666

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)

Sponsor

University of Colorado, Denver

Enrollment

29 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

Head and Neck Cancer Head and Neck Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called NT219 combined with standard immunotherapy (pembrolizumab or cetuximab) for people with advanced head and neck cancer that cannot be cured. The cancer must originate in the mouth, throat, larynx, or nearby areas. **You may be eligible if...** - You are 18 or older - You have incurable squamous cell carcinoma of the head and neck (mouth, tongue, throat, larynx, or sinuses) - Your cancer has returned or spread after prior treatment - Your overall health and lab values (blood counts, kidney, liver) are within acceptable ranges - You have measurable tumors visible on imaging **You may NOT be eligible if...** - Your cancer originated in a salivary gland or skin - You have uncontrolled infection, autoimmune disease, or other serious health conditions - You are pregnant or breastfeeding - You have already received multiple prior immunotherapy regimens Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNT219

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.