INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC

Sponsor: Inhibrx Biosciences, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06295731

Patient View

This phase 2/3 trial assesses the efficacy and safety of INBRX-106 with pembrolizumab in patients with incurable R/M HNSCC, CPS ≥20. Eligible participants must have confirmed HNSCC, measurable disease, and ECOG 0-1. Exclusions include prior systemic therapy for advanced HNSCC and active CNS metastases. INBRX-106 and pembrolizumab are administered via IV every 3 weeks.

Patient Parameters

Program Overview

This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20.

Eligibility Criteria

Inclusion Criteria

  • Has histologically or cytologically confirmed diagnosis of metastatic, recurrent head and neck squamous cell carcinoma (HNSCC) that is considered incurable by local therapies.
  • Has tumor PD-L1 expression of CPS ≥20. Tumor tissue must be provided for PD-L1 biomarker analysis.
  • Has human papilloma virus (HPV) testing results for oropharyngeal cancer by p16 immunohistochemistry (IHC) testing.
  • Has measurable disease per RECIST 1.1 guidelines.
  • Has the primary tumor location of the oral cavity, oropharynx, hypopharynx, or larynx.
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Female patients of childbearing potential must have a negative highly sensitive pregnancy test within 72 hours prior to randomization and must not be breastfeeding.
  • Male and female patients of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use a highly effective method of contraception.

Exclusion Criteria

  • Has primary tumor site (any histology) of nasopharynx or salivary glands or occult primary site.

  • Has received prior systemic therapy (eg, prior chemo-, immune-, or biologic therapy) for locally advanced unresectable or metastatic HNSCC.

    • Prior systemic therapy completed >6 months prior to signing informed consent is allowed if given as part of multimodal treatment for locoregionally advanced disease with curative intent, and no PD/recurrence occurred within 6 months of its completion. Prior systemic immunotherapy in the locoregionally advanced disease with curative intent, including but not limited to anti-PD-(L)1 agents, is allowed if PD/recurrence occurred ≥12 months after its completion.

  • Has clinically active central nervous system metastases and/or carcinomatous meningitis.

  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.

  • Rapidly progressing disease or with features that may confer a high risk of tumor-associated hemorrhage or uncontrolled tumor pain.

  • Current or history of immune-related disease that required systemic treatment in past 2 years, except for replacement therapy.

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