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NCT06295731 · ClinicalTrials.gov registry record · Phase 2
INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC
A Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC), sponsored by Inhibrx Biosciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 410
- Enrollment target
- 20
- Study locations
NCT06295731: Recruiting Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC), sponsored by Inhibrx Biosciences.
NCT06295731 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC) that is actively recruiting participants, run by Inhibrx Biosciences. The registered enrollment target is 410 participants, above the 221-participant average among 14 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials with a reported enrollment target (86% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06295731, a Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC), is actively recruiting participants, sponsored by Inhibrx Biosciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 410 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on 2 consecutive occasions ≥4 weeks apart, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG INBRX-106
Study Locations (20)
California
- City of Hope Medical Center - Duarte
- Los Angeles Cancer Network (LACN) - Los Angeles
- Sutter Health - Sacramento
- UC Davis - Sacramento
- Medical Oncology Associates of San Diego - San Diego
- Sarcoma Oncology Center - Santa Monica
Florida
- University of Florida UF Health Cancer Center - Gainesville
- The Oncology Institute of Hope & Innovation - Miami
- Mid Florida Hematology and Oncology Center - Orange City
- Cleveland Clinic Florida, The Maroone Cancer Center - Weston
Delaware
- ChristianaCare Health Services - Newark
Illinois
- University of Illinois Cancer Center - Chicago
Kentucky
- Norton Cancer Institute - Louisville
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Karmanos Cancer Institute - Detroit
Missouri
- Washington University St. Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 410 participants |
| Start Date | 2024-05-14 |
| Est. Completion | 2029-05 |
| Phase | Phase 2 |
What NCT06295731 shows while recruiting
NCT06295731 is an interventional study that assigns participants to a tested intervention. The registered 410 participants enrollment target is mid-sized for trials with a published cap, above the 221-participant average among 14 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials with a reported enrollment target (86% higher).
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma (HNSCC) appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT06295731 names 20 study sites across 12 states, led by California, Florida, Delaware.
Frequently Asked Questions
What is clinical trial NCT06295731 about?
NCT06295731 is a clinical study titled "INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC". 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 recurr...
What is the current status of trial NCT06295731?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 410 participants. The study started on 2024-05-14. Estimated completion is 2029-05.
What conditions does trial NCT06295731 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma (HNSCC).
What interventions are being tested in trial NCT06295731?
The interventions under investigation include: Pembrolizumab (DRUG), INBRX-106 (DRUG).
Who is sponsoring clinical trial NCT06295731?
This trial is sponsored by Inhibrx Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06295731 being conducted?
This trial has 20 study locations across California, Delaware, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Head and Neck Squamous Cell Carcinoma (HNSCC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06295731's enrollment target sits among peer trials
410 2nd of 14 the highest of 14 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma (HNSCC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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