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FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma

NCT06332092 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-03-16

No results posted yet for this study

Summary

The goal of this FID-007 Clinical Trial is to compare the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). The main questions it aims to answer are: to evaluate the efficacy, and to characterize the safety and tolerability. Eligible participants will be enrolled and randomized to 1 of 2 arms of FID-007 with fixed-dose Cetuximab in each 28-day cycle.

Conditions

Interventions

DRUG

FID007

Patients will receive FID007 via IV infusion at their assigned dose on Days 1, 8, and 15 of each 28-day cycle. Starting from Cycle 2, Cetuximab will be administered every 2 weeks on Days 1 and 15 of each 28-day cycle.

Sponsors & Collaborators

  • Fulgent Pharma LLC.

    lead INDUSTRY

Principal Investigators

  • Fulgent Clinical Sites · Fulgent Pharma LLC.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-10
Primary Completion
2025-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06332092 on ClinicalTrials.gov