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Monoclonal Antibodies
Arm A for Head and Neck Squamous Cell Carcinoma (HNSCC Trial)
Phase 2
Recruiting
Led By Fulgent Clinical Sites
Research Sponsored by Fulgent Pharma LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
HNSCC Trial Summary
This trial aims to test different ways of giving FID-007 along with Cetuximab to patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma. They want to
Who is the study for?
This trial is for adults over 18 with advanced head and neck squamous cell carcinoma that has grown despite previous treatment. Participants must have measurable disease, not be positive for Epstein-Barr virus in the nasopharynx, and be able to give informed consent.Check my eligibility
What is being tested?
The study tests different doses of FID-007 combined with a fixed dose of Cetuximab. Patients are randomly assigned to one of two groups to receive this combination therapy in repeated 28-day cycles, aiming to evaluate its effectiveness and safety.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with cancer treatments like FID-007 and Cetuximab may include skin reactions, infusion-related discomforts, fatigue, nausea, and increased risk of infections.
HNSCC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Secondary outcome measures
Adverse Events (AEs) graded according to the CTCAE version 5.0
Area Under the Plasma Concentration Versus Time Curve (AUC) of FID-007
BOR assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
+11 moreHNSCC Trial Design
2Treatment groups
Active Control
Group I: Arm AActive Control1 Intervention
FID-007 (75 mg/m2) plus Cetuximab (500 mg/m2)
Group II: Arm BActive Control1 Intervention
FID-007 (125 mg/m2) plus Cetuximab (500 mg/m2)
Find a Location
Who is running the clinical trial?
Fulgent Pharma LLC.Lead Sponsor
Fulgent Clinical SitesPrincipal InvestigatorFulgent Pharma LLC.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still being recruited for this clinical trial at the moment?
"Affirmative. Data accessible on clinicaltrials.gov affirms that this particular medical trial is actively seeking suitable candidates. The information was initially published on April 10th, 2024 and last modified on April 15th, 2024. Recruitment aims to include a total of 46 participants from one designated site."
Answered by AI
What are the risks associated with Arm A for individuals involved in the study?
"Given that this trial is in Phase 2, there is limited safety data available for Arm A. Therefore, our team at Power has assigned a safety rating of 2 to it."
Answered by AI
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