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

NCT06332092 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: FID-007-003
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 6

Brief 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

Head and Neck Squamous Cell Carcinoma

Keywords

FID-007; Cetuximab; Paclitaxel; Head and Neck; p16

Outcome Measures

Primary Outcomes (1)

• ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

  To evaluate the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic HNSCC based on Objective Response Rate (ORR).

  Through study completion, an average of 1 year

Secondary Outcomes (14)

• BOR assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

  Through study completion, an average of 1 year

• Duration of Response (DoR) measurement

  Through study completion, an average of 1 year

• Progression-free Survival (PFS) measurement

  Through study completion, an average of 1 year

• Overall Survival (OS) measurement

  Through study completion, an average of 1 year

• Disease Control Rate (DCR) analysis

  Through study completion, an average of 1 year

Study Arms (2)

Arm A

ACTIVE COMPARATOR

FID-007 (75 mg/m2) plus Cetuximab (500 mg/m2)

Drug: FID007

Arm B

ACTIVE COMPARATOR

FID-007 (125 mg/m2) plus Cetuximab (500 mg/m2)

Drug: FID007

Interventions

FID007 DRUG

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.

Also known as: Paclitaxel in Polyethyloxazoline Polymer; FID-007; FID007 (CN); FID 007; Nanoencapsulated Paclitaxel FID-007

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willingness to provide informed consent before the start of any study-specific procedures.
• Age ≥18 years old.
• A diagnosis of recurrent or metastatic HNSCC at 1 of the following sites:
• Nasal/paranasal sinuses
• Nasopharynx (Epstein-Barr virus \[EBV\] negative only)
• Oral cavity
• Oropharynx
• Hypopharynx
• Larynx
• Disease progression after treatment with PD-L1-based immune checkpoint inhibitor at any time. This can be as monotherapy or in combination with chemotherapy.
• Measurable disease according to RECIST version 1.1.
• Adequate treatment washout period of ≥21 days or 5 half-lives, whichever is shorter, for prior chemotherapy, radiotherapy, hormonal therapy, biological therapy, or immunotherapy before the first dose of study drug administration. Note: Palliative radiation is permitted but not ≤7 days before the first dose of study drug.
• ECOG PS of 0 or 1.
• Recovery from any toxic effects of previous chemotherapy, targeted therapy, or radiotherapy as judged by the investigator to Grade ≤1 (except for alopecia) according to NCI CTCAE version 5.0.
• Adequate bone marrow and organ function defined as the following:

You may not qualify if:

• Known hypersensitivity to paclitaxel.
• EBV-positive nasopharyngeal cancer, sinonasal undifferentiated carcinoma, esthesioneuroblastoma, or squamous cell carcinoma of the salivary gland or skin, based on the patient's medical history.
• Received \>1 prior line of anticancer therapy for recurrent or metastatic HNSCC. All patients must be previously treated with an immune checkpoint inhibitor either as monotherapy or in combination with chemotherapy. Patients treated with upfront combination chemo-immunotherapy followed by immunotherapy maintenance are considered to have received only 1 prior line of therapy. Chemotherapy given as part of treatment for locally advanced disease in the adjuvant or neoadjuvant setting is not considered a line of prior therapy for recurrent/metastatic disease. If the patient received prior treatment with Cetuximab, paclitaxel, or nab-paclitaxel in combination with radiation in the locally advanced setting and no relapse within 6 months of treatment discontinuation, enrollment is permitted if the treating physician believes that retreatment with Cetuximab or a taxane is a clinically reasonable option. However, patients who received these agents for recurrent or metastatic disease will be excluded.
• Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, that in the judgment of the investigator could compromise the patient's safety or the study data integrity.
• Preexisting sensory neuropathy of Grade \>1 severity by NCI CTCAE version 5.0 criteria.
• Known history of uncontrolled HIV infection defined as CD4+ cells \<350/mm3.
• Requirement of systemic steroids at daily doses \>10 mg prednisone equivalent systemic exposure daily, including for control of symptoms.
• Use of any CYP2C8 and CYP3A4 inhibitor (eg, ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) or inducer (eg, rifampicin, carbamazepine, phenytoin, efavirenz, and nevirapine) in the previous 14 days before the first dose of study drug until the last PK sample is obtained in the study.
• Known brain metastasis. Note: Patients whose central nervous system metastases have been treated by surgery or radiotherapy, who are no longer on corticosteroids, and who are neurologically stable are eligible.
• Current or recent participation in a study of an investigational product in the prior 4 weeks. Note: Patients who have completed the treatment phase of an investigational study and have entered the follow-up phase of the investigational study may participate in FID-007-003 as long as it has been ≥4 weeks before the first dose of study drug.
• Pregnancy, breastfeeding, or plans to become pregnant during the study or within 24 weeks after the last dose of study drug (Appendix 1 of the protocol).
• Plans to donate/bank or retrieve eggs (ova, oocytes) during the study or within 24 weeks after the last dose of study drug (Appendix 1 of the protocol).

Sponsors & Collaborators

• Fulgent Pharma LLC.: lead

Study Sites (6)

Highlands Oncology - North Hills

Fayetteville, Arkansas, 72703, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033, United States

Location

Moffitt Cancer Center Magnolia Campus

Tampa, Florida, 33612, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46804, United States

Location

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology - Northeast Texas Cancer & Research Institute

Tyler, Texas, 75702, United States

Location

Related Publications (21)

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MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Fulgent Clinical Sites

  Fulgent Pharma LLC.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two different dosing regimens of FID-007 in combination with fixed-dose Cetuximab

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 27, 2024
• Study Start: April 10, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)