NCT06295731

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

A Phase 2/3, Randomized Study of INBRX-106 Combined With Pembrolizumab Versus Pembrolizumab as First Line Treatment for Patients With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 (CPS ≥20) (HexAgon-HN)

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Inhibrx Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

Type	Name	Description
DRUG	INBRX-106	INBRX-106 by intravenous (IV) infusion, given every 3 weeks (QW3)
DRUG	Pembrolizumab	Pembrolizumab 200 mg by intravenous (IV) infusion, given every 3 weeks (QW3)

Timeline

• Start date: 2024-05-14
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2024-03-06
• Last updated: 2026-03-31

Locations

87 sites across 13 countries: United States, Australia, Belgium, Bulgaria, France, Italy, Malaysia, Poland, Romania, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study