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

Study acronym: HexAgon-HN
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv15
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 88 to 87v14 Show 1 more changeShow less
    • Study sites: 88 to 87
  3. Study sites: 78 to 88v13
  4. Study sites: 71 to 78v12
  5. Study sites: 64 to 71v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 61 to 64v10
  2. Study sites: 47 to 61v9
  3. Study sites: 39 to 47v8
  4. Study sites: 23 to 39v7
  5. Study sites: 14 to 23v6
  6. Study sites: 6 to 14v5
  7. Study sites: 3 to 6v4
  8. Site details revised at 1 of 3 sitesv3
  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of May 2024 to May 14, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of May 2024 to May 14, 2024
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Inhibrx
4 trials monitored
See 1 trial at risk
Head & Neck Cancer
2,060 trials monitored
See 120 trials at risk
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.
Trial Details
NCT Number NCT06295731
Lead Sponsor Inhibrx Biosciences, Inc
Conditions Head and Neck Squamous Cell Carcinoma (HNSCC)
Enrollment 410 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov