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Monoclonal Antibodies

INBRX-106 + Pembrolizumab for Head and Neck Cancer

Verified Trial
Phase 2 & 3
Recruiting
Research Sponsored by Inhibrx Biosciences, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you recently been diagnosed with recurrent or metastatic HNSCC?
Was your cancer previously treated?
Timeline
Screening 1 day
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Summary

This trial will test the effectiveness and safety of a new drug called INBRX-106 in combination with pembrolizumab compared to pembrolizumab alone as the first treatment for patients

Who is the study for?
This trial is for adults with a specific type of head and neck cancer (HNSCC) that can't be cured by surgery or radiation. They must have high levels of a protein called PD-L1, not been treated before, and their cancer should be measurable by scans. Participants need to be fairly healthy overall (good performance status), able to provide tissue samples, and if they can have children, they must use effective birth control.
What is being tested?
The study is testing INBRX-106 combined with Pembrolizumab against just Pembrolizumab in patients with advanced head and neck cancer expressing high PD-L1 levels. It's designed to see which treatment works better as the first line of attack without previous treatments.
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in various organs due to the body's immune system becoming overactive, infusion reactions from the drug entering the bloodstream, fatigue, skin issues, hormonal changes, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 1 day
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 1 day for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2: Objective Response Rate (ORR)
Phase 3: Overall Survival (OS)
Phase 3: Progression-Free Survival (PFS)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
Incidence and severity of Adverse Events (AEs)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: INBRX-106 plus pembrolizumabExperimental Treatment2 Interventions
Participants will receive INBRX-106 plus pembrolizumab, both given by intravenous (IV) infusion every 3 weeks (QW3)
Group II: pembrolizumab monotherapy (+ placebo in phase 3 part)Active Control2 Interventions
Participants will receive pembrolizumab (plus placebo in Phase 3), given by intravenous (IV) infusion every 3 weeks (QW3)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Inhibrx Biosciences, IncLead Sponsor
6 Previous Clinical Trials
803 Total Patients Enrolled
Inhibrx, Inc.Lead Sponsor
8 Previous Clinical Trials
1,337 Total Patients Enrolled
Clinical LeadStudy DirectorInhibrx Biosciences, Inc
1 Previous Clinical Trials
240 Total Patients Enrolled
~273 spots leftby May 2029
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