NCT07408063

A Comprehensive Multiomic Biomarker Evaluation Across Two Single-arm Cohorts to Elucidate Mechanisms of Response and Resistance in Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC)

GSK5764227 (Anti-B7H3 Antibody Drug Conjugate) Monotherapy or in Combination With Dostarlimab in Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC): a Multiomic Evaluation of Biomarkers of Response and Resistance (BeeHive)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The BeeHive study is an investigator-initiated, single center, open-label phase II clinical trial that is designed to conduct a comprehensive multiomic biomarker evaluation across two single-arm cohorts to elucidate mechanisms of response and resistance in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). It is anticipated that about 20 patients will be enrolled in Cohort A and an additional of 10 patients will be enrolled in Cohort B.

Detailed description

This investigator-initiated study is designed to conduct a comprehensive multiomic biomarker evaluation across two single-arm cohorts to elucidate mechanisms of response and resistance in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Cohort A will enroll approximately 20 patients. All participants will receive GSK5764227 monotherapy at a starting dose of 8 mg/kg Intravenously every 3 weeks (IV Q3W) in a 21-day treatment cycle. Cohort B will start only after Cohort A has been initiated, with enrollment of approximately 10 patients. All participants will receive a combination of GSK5764227 (8 mg/kg IV Q3W) and dostarlimab (500 mg IV Q3W). The study drug, GSK5764227, is a new kind of medicine known as an antibody drug conjugate (ADC). GSK5764227 binds to a substance known as B7-H3 that is found on the surface of tumor cells. Once GSK5764227 binds to B7-H3, it enters the tumor cell and releases a chemotherapy-type drug (known as GSK5757810) which has been shown to damage and kill tumor cells. The study treatment will generally continue until confirmed disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, unacceptable toxicity, withdrawal of participant consent, noncompliance, or Investigator decision based on clinical deterioration or other relevant factors. For participants receiving dostarlimab, treatment will not exceed a maximum duration of 24 months in the absence of prior progression. There is the possibility to continue treatment beyond initial progression at Study PI's judgment. This investigator-initiated phase II study is expected to require approximately 40 months from the time the first participant signs the informed consent form until the last participant completes their last study visit.

Conditions

• Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	GSK5764227	GSK5764227 is a new kind of drug known as an antibody drug conjugate (ADC). GSK5764227 works by recognizing and attaching to a substance known as B7-H3 that is found on the surface of certain tumor cells. Once GSK5764227 binds to B7-H3, it enters the tumor cell and releases a chemotherapy-type drug (known as GSK5757810) which has been shown to damage and kill tumor cells.
DRUG	Dostarlimab	Dostarlimab belongs to a class of drugs called PD-1 inhibitors that use your own immune system to treat cancer (immunotherapy). Dostarlimab is designed to help your immune system by attaching to a protein called PD-1 and stopping one of the signals that keeps your immune system from recognizing the cancer. This may help your immune system attack and destroy the cancer cells. Dostarlimab is approved in some countries to treat patients with endometrial cancer (cancer of the uterus) that is advanced or has relapsed. It is also approved in the United States for all solid cancers that have a particular tumor genetic characteristic and have worsened during or after previous treatment. Dostarlimab has not yet been approved by Health Canada to treat head and neck cancer.

Timeline

• Start date: 2026-02-02
• Primary completion: 2030-06-30
• Completion: 2030-06-30
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: Canada