Trial Title:
FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT06332092
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Paclitaxel
Conditions: Keywords:
FID-007
Cetuximab
Paclitaxel
Head and Neck
p16
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Intervention model description:
Two different dosing regimens of FID-007 in combination with fixed-dose Cetuximab
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FID007
Description:
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.
Arm group label:
Arm A
Arm group label:
Arm B
Other name:
Paclitaxel in Polyethyloxazoline Polymer; FID-007; FID007 (CN); FID 007; Nanoencapsulated Paclitaxel FID-007
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Ability to understand and willingness to provide informed consent before the start
of any study-specific procedures.
2. Age ≥18 years old.
3. A diagnosis of recurrent or metastatic HNSCC at 1 of the following sites:
1. Nasal/paranasal sinuses
2. Nasopharynx (Epstein-Barr virus [EBV] negative only)
3. Oral cavity
4. Oropharynx
5. Hypopharynx
6. Larynx
4. Disease progression after treatment with PD-L1-based immune checkpoint inhibitor at
any time. This can be as monotherapy or in combination with chemotherapy.
5. Measurable disease according to RECIST version 1.1.
6. 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.
7. ECOG PS of 0 or 1.
8. 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.
9. 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
10. An estimated life expectancy of at least 3 months based on investigator judgment.
11. Negative serum pregnancy test result at screening for female patients of
childbearing potential.
12. Willingness to abide by the contraceptive requirements in Appendix 1 of the
protocol.
Exclusion Criteria:
1. Known hypersensitivity to paclitaxel.
2. 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.
3. 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.
4. 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.
5. Preexisting sensory neuropathy of Grade >1 severity by NCI CTCAE version 5.0
criteria.
6. Known history of uncontrolled HIV infection defined as CD4+ cells <350/mm3.
7. Requirement of systemic steroids at daily doses >10 mg prednisone equivalent
systemic exposure daily, including for control of symptoms.
8. 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.
9. 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.
10. 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.
11. 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).
12. 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Highlands Oncology - North Hills
Address:
City:
Fayetteville
Zip:
72703
Country:
United States
Status:
Recruiting
Contact:
Last name:
Contact Us
Phone:
479-587-1700
Investigator:
Last name:
J. Thaddeus Beck
Email:
Principal Investigator
Facility:
Name:
USC/Norris Comprehensive Cancer Center and Hospital
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
General Inquiries
Phone:
323-865-3000
Email:
uscnorrisinfo@med.usc.edu
Investigator:
Last name:
Jacob Thomas
Email:
Principal Investigator
Facility:
Name:
Moffitt Cancer Center Magnolia Campus
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Participating Trials
Phone:
813-745-6100
Investigator:
Last name:
Guilherme Rabinowits
Email:
Principal Investigator
Facility:
Name:
Fort Wayne Medical Oncology and Hematology
Address:
City:
Fort Wayne
Zip:
46804
Country:
United States
Status:
Recruiting
Contact:
Last name:
General Contact
Phone:
260-484-8830
Email:
info@fwmoh.com
Investigator:
Last name:
Ahad Sadiq
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christine Terraciano Terraciano
Phone:
214-370-1000
Email:
Christine.terraciano@usoncology.com
Investigator:
Last name:
Eric Nadler
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - Northeast Texas Cancer & Research Institute
Address:
City:
Tyler
Zip:
75702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Texas Oncology - Tyler
Phone:
903-579-9800
Investigator:
Last name:
Donald Richards
Email:
Principal Investigator
Start date:
April 10, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Fulgent Pharma LLC.
Agency class:
Industry
Source:
Fulgent Pharma LLC.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06332092
