Ordastobart (INBRX-106) Add-on to Pembrolizumab in 1L HPV+ PD-L1+ R/M OPSCC (HexAgon-HN)

This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody ordastobart (INBRX-106) combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with recurrent or metastatic (R/M) HPV-positive Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC) expressing PD-L1.

Trial Details

NCT ID
NCT06295731
Phase
PHASE2 / PHASE3
Sponsor
Inhibrx Biosciences, Inc
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • INBRX-106
  • Pembrolizumab
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Sacramento, California, United States|38.58157,-121.4944
  • Newark, Delaware, United States|39.68372,-75.74966
  • Gainesville, Florida, United States|29.65163,-82.32483
  • Orange City, Florida, United States|28.94888,-81.29867

Key Eligibility Criteria

  • Has histologically or cytologically confirmed diagnosis of recurrent/metastatic oropharyngeal squamous cell carcinoma (OPSCC) considered incurable …
  • Has tumor PD-L1 expression with a combined proportion score (CPS) ≥1 by central testing.
  • HPV-positive tumor status as assessed locally by p16 immunohistochemistry (IHC).
  • Has measurable disease per RECIST 1.1 guidelines.

For full eligibility, visit ClinicalTrials.gov.

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