drugset / Trial / NCT06295731

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

NCT06295731

Phase 2/3 Active not recruiting 410 enrolled Inhibrx Biosciences, Inc
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2024-05-14
Primary completion
2029-05
Completion
2029-05

Drugs

EvaluationDrugModalityDoseRoute
Subject INBRX-106 Unknown Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous