NCT06295731 · Inhibrx Biosciences, Inc
INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC
(HexAgon-HN)
What this study is about
This seamless phase 2/3 randomly assigned controlled study will evaluate the effectiveness 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.
View original scientific description
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.
Interventions
DRUG
INBRX-106
INBRX-106 0.1 mg/kg by intravenous (IV) infusion, given every 3 weeks (QW3)
DRUG
Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given every 3 weeks (QW3)
Primary outcome measures
Phase 2: Objective Response Rate by investigator (ORRinv)
Time frame: From randomization to progressive disease (PD) or death (up to 1 year)
defined as the proportion of patients with complete response (CR) or partial response (PR) on 2 consecutive occasions ≥4 weeks apart, as determined by the Investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Phase 3: Progression-Free Survival by Investigator (PFSinv)
Time frame: From randomization to PD or death (up to 4 years)
defined as the time from randomization to first occurrence of PD, as determined by the Investigator according to RECIST 1.1, or death from any cause (whichever occurs first).
Phase 3: Overall Survival (OS)
Time frame: From randomization until death from any cause (up to 4 years)
defined as the time from randomization to death from any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Has histologically or cytologically confirmed diagnosis of metastatic, recurrent head and neck squamous cell carcinoma (HNSCC) that is considered incurable by local therapies.
- Has tumor PD-L1 expression of CPS ≥20. Tumor tissue must be provided for PD-L1 biomarker analysis.
- Has human papilloma virus (HPV) testing results for oropharyngeal cancer by p16 immunohistochemistry (IHC) testing.
- Has measurable disease per RECIST 1.1 guidelines.
- Has the primary tumor location of the oral cavity, oropharynx, hypopharynx, or larynx.
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Female patients of childbearing potential must have a negative highly sensitive pregnancy test within 72 hours prior to randomization and must not be breastfeeding.
- Male and female patients of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use a highly effective method of contraception.
Where
- Duarte, California
- Los Angeles, California
- Sacramento, California
- San Diego, California
- Santa Monica, California
- Newark, Delaware
- Gainesville, Florida
- Miami, Florida
- Orange City, Florida
- Weston, Florida
- Chicago, Illinois
- Louisville, Kentucky
And 13 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 27, 2026 · Source of record for eligibility and locations