Actively Recruiting
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)
Led by University Health Network, Toronto · Updated on 2026-04-29
30
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Be at least 18 years old
- Have confirmed recurrent or metastatic head and neck squamous cell carcinoma not suitable for curative surgery or radiation
- Have documented HPV status for oropharyngeal cancer
- Have at least one measurable tumor lesion
- Have an ECOG performance status of 0 or 1
- Have a life expectancy greater than 12 weeks
- For Cohort A: received prior immune checkpoint inhibitor and progressed after platinum-based therapy in recurrent/metastatic setting
- For Cohort B: no prior systemic therapy for recurrent/metastatic disease
- Willing and able to have new tumor biopsies during screening and on-treatment
- No evidence of past or active hepatitis B infection except specified exceptions
- No active hepatitis C infection; patients with undetectable HCV RNA are eligible
- No known history of HIV infection; testing required if risk factors exist
- Willing and able to comply with study visits, treatments, and tests
- Patients with feeding tubes are eligible
- Have adequate organ function as defined in protocol
- Female participants must meet protocol-specific criteria
- Male participants must agree to protocol criteria during treatment and for at least 5 months after last dose
You will not qualify if you...
- Non-squamous head and neck cancers or tumors arising from nasopharynx or paranasal sinuses
- Unknown primary tumors even if squamous histology is confirmed
- Unresolved adverse reactions from prior therapy except specified conditions
- Participation in another investigational study within 4 weeks prior to screening
- Prior treatment with B7-H3 targeted agents like orlotamab or enoblituzumab
- Autoimmune disease requiring systemic treatment within 2 years
- For dostarlimab recipients, chronic immunosuppressive therapy within 30 days prior to first dose except low-dose corticosteroids or replacement therapy
- Serious thromboembolic events within 3 months prior to first dose
- Brain metastases unless asymptomatic, stable, and meeting specified criteria
- History of other primary solid tumors except certain cured, inactive, or treated cancers
- Major surgery within 4 weeks prior to first dose
- History of bone marrow or organ transplant
- Cardiac abnormalities as defined in protocol
- Poorly controlled hypertension or hypertensive crisis within 2 weeks prior to first dose
- Significant bleeding or blood transfusions within specified recent timeframes
- Serious infections within 4 weeks prior to first dose
- History or evidence of pulmonary disease
- Severe neurological or psychiatric disorders or conditions interfering with safety or compliance
- Active renal conditions such as dialysis requirement
- Allergy or hypersensitivity to study drugs or components
- Receipt of live vaccine within 30 days before study intervention
- Any condition jeopardizing safety or study assessments as judged by investigator
- Certain hepatic diseases or cirrhosis, positive hepatitis B or C tests within 3 months prior to first dose
- Recent anticancer therapy without required washout period
- Recent local palliative or extensive radiation therapy within specified timeframes
- Concurrent use or need for prohibited medications within 7 days before first dose
AI-Screening
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Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Actively Recruiting
Research Team
L
Lillian Siu, MD
CONTACT
M
Minge Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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