Head and Neck Squamous Cell CarcinomaPhase 2HNSCCNCT06332092

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

A Phase 2 study testing FID007 in people with Head and Neck Squamous Cell Carcinoma, run by Fulgent Pharma LLC. at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Head and Neck Squamous Cell Carcinoma
What is being tested?: FID007
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 6 sitesUnited States
Study dates: 10 Apr 2024to 31 Dec 2026
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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:
Bone marrow function
Absolute neutrophil count ≥1500/mm3 (growth factor administration is not permitted ≤1 week before the screening assessment)
Platelet count ≥100,000/mm3 (platelet transfusion is not permitted ≤1 week before the screening assessment)
Hemoglobin ≥8 g/dL (criteria must be met without packed red blood cell transfusion ≤1 week before the screening assessment; chronic treatment with erythropoietin is permitted if the patient is on erythropoietin for ≥8 weeks)
Blood clotting function
International normalized ratio (INR) ≤1.5 × upper limit of normal (ULN) and activated partial thromboplastin time ≤1.5 × ULN (except patients who are receiving therapeutic anticoagulation and whose INR should be within the therapeutic range)
Renal function
•Calculated clearance (using the Cockroft-Gault formula) ≥40 mL/min/1.73 m2. Actual body weight should be used for calculating creatinine clearance. For patients with a body mass index >30 kg/m2, lean body weight should be used instead
Hepatic function
Total bilirubin ≤1.5 × ULN (patients with Gilbert's disease can have bilirubin >1.5 × ULN to <3 × ULN)
Aspartate aminotransferase/alanine aminotransferase ≤3 × ULN
An estimated life expectancy of at least 3 months based on investigator judgment.
Negative serum pregnancy test result at screening for female patients of childbearing potential.
Willingness to abide by the contraceptive requirements in Appendix 1 of the protocol.

Who cannot join

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.

Show all 12Show fewer

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).

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Highlands Oncology - North Hills
Fayetteville, Arkansas, 72703
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033
Moffitt Cancer Center Magnolia Campus
Tampa, Florida, 33612
Texas Oncology - Northeast Texas Cancer & Research Institute
Tyler, Texas, 75702

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Multicenter, Open-label, Study of FID-007 in Combination With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma

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.

Read the detailed description

The goal of this FID-007 Randomized, Multicenter, Open-label 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) based on objective response rate. The main questions it aims to answer are:

To evaluate the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients based on Best Overall Response (BOR), Duration of Response (DoR), Disease Control Rate (DCR), Progression-Free Survival (PFS), and Overall Survival (OS).
To characterize the pharmacokinetics (PK) of FID-007 and its metabolites (6-α-hydroxypaclitaxel and 3'-p-hydroxypaclitaxel) following administration of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic HNSCC.
To characterize the safety and tolerability of different dosing regimens of FID-007 in combination with Cetuximab in patients.

Eligible participants will be enrolled and randomized to 1 of 2 arms of FID-007 with fixed-dose Cetuximab (starting from Cycle 2, 500 mg/m2 intravenous [IV] infusion every 2 weeks on Days 1 and 15 of each 28-day cycle). Patients will receive FID-007 via IV infusion over 30 minutes at their assigned dose on Days 1, 8, and 15 of each 28-day cycle.

Patients will continue to receive Cetuximab and FID-007 until they meet the study drug discontinuation criteria.

Conditions: Head and Neck Squamous Cell Carcinoma
Being tested: FID007
Keywords: FID-007, Cetuximab, Paclitaxel, Head and Neck, p16
Medical subject headings: Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FID007Drug
Also called Paclitaxel in Polyethyloxazoline Polymer; FID-007; FID007 (CN); FID 007; Nanoencapsulated Paclitaxel FID-007
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.

Study groups in NCT06332092
Study group	Role	What they receive
Arm A	Active comparator	FID-007 (75 mg/m2) plus Cetuximab (500 mg/m2) Receives: Drug: FID007
Arm B	Active comparator	FID-007 (125 mg/m2) plus Cetuximab (500 mg/m2) Receives: Drug: FID007

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Through study completion, an average of 1 year

Secondary outcomes (14)

BOR assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Best Overall Response (BOR) measures the changes in tumor mass, growth (progression) or shrinkage (response) using the RECIST criteria.
Measured: Through study completion, an average of 1 year
Duration of Response (DoR) measurement
The length of time that a tumor continues to respond to treatment without the cancer growing or spreading will be recorded.
Measured: Through study completion, an average of 1 year
Progression-free Survival (PFS) measurement
The length of time to either radiological confirmed progression or death from any cause will be recorded.
Measured: Through study completion, an average of 1 year
Overall Survival (OS) measurement
The length of time to death from any cause will be recorded.
Measured: Through study completion, an average of 1 year
Disease Control Rate (DCR) analysis
The percentage of patients with advanced HNSCC who have achieved complete response, partial response and stable disease to different treatment regimens will be calculated.
Measured: Through study completion, an average of 1 year
Adverse Events (AEs) graded according to the CTCAE version 5.0
Safety and tolerability of different dosing regiments will be assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Through study completion, an average of 1 year
Vital Signs safety assessments
Vital signs measurements include body temperature in Fahrenheit, respiratory rate, heart rate, and systolic and diastolic blood pressure measurements. Any confirmed, clinically significant abnormal vital sign measurements must be recorded as AEs.
Measured: Through study completion, an average of 1 year
Clinical Laboratory safety assessments
Routine hematology, chemistry, and urinalysis to be performed at visits. Any confirmed, clinically significant abnormal laboratory results must be recorded as AEs.
Measured: Through study completion, an average of 1 year
ECGs safety assessment
12-lead Electrocardiograms (ECGs) should be performed before the start and after the end of FID-007 infusion. An assessment of normal, clinically significant or abnormal, not clinically significant will be recorded.
Measured: Through study completion, an average of 1 year
Area Under the Plasma Concentration Versus Time Curve (AUC) of FID-007
Application of pharmacokinetic principles to the safe and effective therapeutic management of drugs in an individual patient.
Measured: Cycle 2 (each cycle is 28 days)
Peak Plasma Concentration (Cmax)
Application of pharmacokinetic parameters to the safe and effective therapeutic management of drugs in an individual patient.
Measured: Cycle 2 (each cycle is 28 days)
Terminal/elimination half-life (t1/2)
Application of pharmacokinetic parameters to the safe and effective therapeutic management of drugs in an individual patient.
Measured: Cycle 2 (each cycle is 28 days)
Clearance (CL)
Application of pharmacokinetic parameters to the safe and effective therapeutic management of drugs in an individual patient.
Measured: Cycle 2 (each cycle is 28 days)
Volume of Distribution (Vd)
Application of pharmacokinetic parameters to the safe and effective therapeutic management of drugs in an individual patient.
Measured: Cycle 2 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 202431 Dec 2026

First posted27 Mar 2024
Study start10 Apr 2024
Primary completion31 Dec 2025
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Model description: Two different dosing regimens of FID-007 in combination with fixed-dose Cetuximab
Masking: None (open label)
Enrolment: 46 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06332092
Sponsor's protocol ID: FID-007-003
Acronym: HNSCC
Status last verified: Oct 2026
First submitted: 12 Mar 2024
Last updated: 14 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Barsouk A, Aluru JS, Rawla P, Saginala K, Barsouk A. Epidemiology, Risk Factors, and Prevention of Head and Neck Squamous Cell Carcinoma. Med Sci (Basel). 2023 Jun 13;11(2):42. doi: 10.3390/medsci11020042.
PubMed 37367741
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338
Burtness B, Rischin D, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Brana I, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Ge J, Swaby RF, Gumuscu B, Harrington K. Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score. J Clin Oncol. 2022 Jul 20;40(21):2321-2332. doi: 10.1200/JCO.21.02198. Epub 2022 Mar 25.
PubMed 35333599
Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; Eastern Cooperative Oncology Group. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005 Dec 1;23(34):8646-54. doi: 10.1200/JCO.2005.02.4646.
PubMed 16314626
Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.
PubMed 18784101
Vermorken JB, Trigo J, Hitt R, Koralewski P, Diaz-Rubio E, Rolland F, Knecht R, Amellal N, Schueler A, Baselga J. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol. 2007 Jun 1;25(16):2171-7. doi: 10.1200/JCO.2006.06.7447.
PubMed 17538161
Fury MG, Sherman E, Lisa D, Agarwal N, Algazy K, Brockstein B, Langer C, Lim D, Mehra R, Rajan SK, Korte S, Lipson B, Yunus F, Tanvetyanon T, Smith-Marrone S, Ng K, Xiao H, Haque S, Pfister DG. A randomized phase II study of cetuximab every 2 weeks at either 500 or 750 mg/m2 for patients with recurrent or metastatic head and neck squamous cell cancer. J Natl Compr Canc Netw. 2012 Nov 1;10(11):1391-8. doi: 10.6004/jnccn.2012.0144.
PubMed 23138167
Herbst RS, Kelly K, Chansky K, Mack PC, Franklin WA, Hirsch FR, Atkins JN, Dakhil SR, Albain KS, Kim ES, Redman M, Crowley JJ, Gandara DR. Phase II selection design trial of concurrent chemotherapy and cetuximab versus chemotherapy followed by cetuximab in advanced-stage non-small-cell lung cancer: Southwest Oncology Group study S0342. J Clin Oncol. 2010 Nov 1;28(31):4747-54. doi: 10.1200/JCO.2009.27.9356. Epub 2010 Oct 4.
PubMed 20921467
Jain RK. Transport of molecules in the tumor interstitium: a review. Cancer Res. 1987 Jun 15;47(12):3039-51.
PubMed 3555767
Baban DF, Seymour LW. Control of tumour vascular permeability. Adv Drug Deliv Rev. 1998 Oct 5;34(1):109-119. doi: 10.1016/s0169-409x(98)00003-9.
PubMed 10837673
Serpe L. Conventional chemotherapeutic drug nanoparticles for cancer treatment. Kumar CS, ed. Nanomaterials for Cancer Therapy. Vol 6. Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim; 2006:1-39.
Desai N, Trieu V, Yao Z, Louie L, Ci S, Yang A, Tao C, De T, Beals B, Dykes D, Noker P, Yao R, Labao E, Hawkins M, Soon-Shiong P. Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of cremophor-free, albumin-bound paclitaxel, ABI-007, compared with cremophor-based paclitaxel. Clin Cancer Res. 2006 Feb 15;12(4):1317-24. doi: 10.1158/1078-0432.CCR-05-1634.
PubMed 16489089
Grau JJ, Caballero M, Verger E, Monzo M, Blanch JL. Weekly paclitaxel for platin-resistant stage IV head and neck cancer patients. Acta Otolaryngol. 2009 Nov;129(11):1294-9. doi: 10.3109/00016480802590451.
PubMed 19863327
Gibson MK, Li Y, Murphy B, Hussain MH, DeConti RC, Ensley J, Forastiere AA; Eastern Cooperative Oncology Group. Randomized phase III evaluation of cisplatin plus fluorouracil versus cisplatin plus paclitaxel in advanced head and neck cancer (E1395): an intergroup trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2005 May 20;23(15):3562-7. doi: 10.1200/JCO.2005.01.057.
PubMed 15908667
Maghami E, Ismaila N, Alvarez A, Chernock R, Duvvuri U, Geiger J, Gross N, Haughey B, Paul D, Rodriguez C, Sher D, Stambuk HE, Waldron J, Witek M, Caudell J. Diagnosis and Management of Squamous Cell Carcinoma of Unknown Primary in the Head and Neck: ASCO Guideline. J Clin Oncol. 2020 Aug 1;38(22):2570-2596. doi: 10.1200/JCO.20.00275. Epub 2020 Apr 23.
PubMed 32324430

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Multicenter, Open-label, Study of FID-007 in Combination With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06332092
Acronym / sponsor ID: HNSCC / FID-007-003
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: FID-007, Cetuximab, Paclitaxel, Head and Neck, p16
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 46 participants (estimated)
Lead sponsor: Fulgent Pharma LLC.Industry (pharma, biotech, devices)
Study start: 10 Apr 2024 (actual)
Primary completion: 31 Dec 2025 (actual)
Study completion: 31 Dec 2026 (estimated)
First posted: 27 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To evaluate the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients based on Best Overall Response (BOR), Duration of Response (DoR), Disease Control Rate (DCR), Progression-Free Survival (PFS), and Overall Survival (OS).
To characterize the pharmacokinetics (PK) of FID-007 and its metabolites (6-α-hydroxypaclitaxel and 3'-p-hydroxypaclitaxel) following administration of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic HNSCC.
To characterize the safety and tolerability of different dosing regimens of FID-007 in combination with Cetuximab in patients.

Patients will continue to receive Cetuximab and FID-007 until they meet the study drug discontinuation criteria.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: Two different dosing regimens of FID-007 in combination with fixed-dose Cetuximab

Arm	Type	Receives
Arm A	Active comparator	Drug: FID007FID-007 (75 mg/m2) plus Cetuximab (500 mg/m2)
Arm B	Active comparator	Drug: FID007FID-007 (125 mg/m2) plus Cetuximab (500 mg/m2)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (29 listed)

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:
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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FID007Also: Paclitaxel in Polyethyloxazoline Polymer; FID-007; FID007 (CN); FID 007; Nanoencapsulated Paclitaxel FID-007Patients 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.	Drug	Arm A, Arm B

Primary outcome

ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Through study completion, an average of 1 year
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).

14 secondary outcomes

BOR assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Through study completion, an average of 1 year
Duration of Response (DoR) measurement
Time frame: Through study completion, an average of 1 year
Progression-free Survival (PFS) measurement
Time frame: Through study completion, an average of 1 year
Overall Survival (OS) measurement
Time frame: Through study completion, an average of 1 year
Disease Control Rate (DCR) analysis
Time frame: Through study completion, an average of 1 year
Adverse Events (AEs) graded according to the CTCAE version 5.0
Time frame: Through study completion, an average of 1 year
Vital Signs safety assessments
Time frame: Through study completion, an average of 1 year
Clinical Laboratory safety assessments
Time frame: Through study completion, an average of 1 year
ECGs safety assessment
Time frame: Through study completion, an average of 1 year
Area Under the Plasma Concentration Versus Time Curve (AUC) of FID-007
Time frame: Cycle 2 (each cycle is 28 days)
Peak Plasma Concentration (Cmax)
Time frame: Cycle 2 (each cycle is 28 days)
Terminal/elimination half-life (t1/2)
Time frame: Cycle 2 (each cycle is 28 days)
Clearance (CL)
Time frame: Cycle 2 (each cycle is 28 days)
Volume of Distribution (Vd)
Time frame: Cycle 2 (each cycle is 28 days)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
Background: PubMed 37367741Barsouk A, Aluru JS, Rawla P, Saginala K, Barsouk A. Epidemiology, Risk Factors, and Prevention of Head and Neck Squamous Cell Carcinoma. Med Sci (Basel). 2023 Jun 13;11(2):42. doi: 10.3390/medsci11020042.
Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Background: PubMed 35333599Burtness B, Rischin D, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Brana I, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Ge J, Swaby RF, Gumuscu B, Harrington K. Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score. J Clin Oncol. 2022 Jul 20;40(21):2321-2332. doi: 10.1200/JCO.21.02198. Epub 2022 Mar 25.
Background: PubMed 16314626Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; Eastern Cooperative Oncology Group. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005 Dec 1;23(34):8646-54. doi: 10.1200/JCO.2005.02.4646.
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Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fulgent Clinical Sites principal investigator

Fulgent Pharma LLC.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FID007 in people with Head and Neck Squamous Cell Carcinoma, run by Fulgent Pharma LLC. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06332092, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.