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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Exclusion Criteria:

- Has primary tumor site (any histology) of nasopharynx or salivary glands or occult primary site.

- Has received prior systemic therapy (eg, prior chemo-, immune-, or biologic therapy) for locally advanced unresectable or metastatic HNSCC.

- Prior systemic therapy completed >6 months prior to signing informed consent is allowed if given as part of multimodal treatment for locoregionally advanced disease with curative intent, and no PD/recurrence occurred within 6 months of its completion.

Prior systemic immunotherapy in the locoregionally advanced disease with curative intent, including but not limited to anti-PD-(L)1 agents, is allowed if PD/recurrence occurred ≥12 months after its completion.

- Has clinically active central nervous system metastases and/or carcinomatous meningitis.

- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.

- Rapidly progressing disease or with features that may confer a high risk of tumor-associated hemorrhage or uncontrolled tumor pain.

- Current or history of immune-related disease that required systemic treatment in past 2 years, except for replacement therapy.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06295731
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Inhibrx Biosciences, Inc
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Lead
Principal Investigator Affiliation	Inhibrx Biosciences, Inc
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Belgium, France, Italy, Korea, Republic of, Malaysia, Poland, Romania, Spain, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Head and Neck Squamous Cell Carcinoma (HNSCC)

Arms & Interventions

Arms

Experimental: INBRX-106 plus pembrolizumab

Participants will receive INBRX-106 plus pembrolizumab, both given by intravenous (IV) infusion every 3 weeks (QW3)

Active Comparator: pembrolizumab monotherapy (+ placebo in phase 3 part)

Participants will receive pembrolizumab (plus placebo in Phase 3), given by intravenous (IV) infusion every 3 weeks (QW3)

Interventions

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope Medical Center, Duarte, California

Status

Recruiting

Address

City of Hope Medical Center

Duarte, California, 91010

Site Contact

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THANC’s Mission