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NCT06295731 · ClinicalTrials.gov record · last posted 2026-05-08

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

Study acronym: HexAgon-HN
StatusActive, Not Recruiting
PhasePhase 2/3
Started2024-05-14
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from the ClinicalTrials.gov record
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.

Amendment record 14 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 14 times since 2024-02-28; most recent amendment 2026-05-06. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2026-03-26
Status change Recruiting→Active, Not Recruitingv13
2024-05-14
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT06295731
Lead Sponsor Inhibrx Biosciences, Inc
Conditions Head and Neck Squamous Cell Carcinoma (HNSCC)
Enrollment 410 participants
Start Date 2024-05-14
Primary Completion 2029-05 (estimated)
Study Completion 2029-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-08