FID-007 for Head and Neck Cancer

No longer recruiting at 1 trial location

Overseen By Sandy Tran, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Southern California

Must not be taking: Taxane chemotherapies, Immunosuppressive therapy

Disqualifiers: Nasopharynx, Salivary gland, Skin, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering paclitaxel, a common chemotherapy drug, to treat head and neck squamous cell carcinoma. The treatment, called PEOX-based Polymer Encapsulated Paclitaxel FID-007, uses a special polymer to help the drug penetrate deeper into tumors while minimizing impact on healthy cells. Researchers aim to assess its effects on immune cells around the tumor and its potential to improve outcomes after surgery. The trial seeks participants with surgically removable head and neck cancer, particularly in the oral cavity or oropharynx. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive therapy, you must stop it at least 14 days before enrolling, except for a low dose of prednisone (10mg or less).

Is there any evidence suggesting that FID-007 is likely to be safe for humans?

Research has shown that paclitaxel, the active ingredient in FID-007, is a well-known chemotherapy drug. The FDA has approved it for treating other types of cancer, which provides some confidence in its safety. FID-007 is a new version of paclitaxel, encased in a special material called PEOX, enhancing its ability to target tumors.

Although this trial is in its early stages and safety is still under study, initial research suggests it is well-tolerated. The special packaging may reduce side effects by delivering more of the drug to the tumor and less to healthy cells. However, like all treatments, some side effects may occur, and the trial closely monitors safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for head and neck cancer, which typically involve conventional chemotherapy and radiation, FID-007 offers a novel approach by using a PEOX-based polymer to encapsulate paclitaxel. This encapsulation may enhance the delivery and effectiveness of the drug, allowing it to target cancer cells more directly and potentially reducing side effects. Researchers are excited because this method could improve the precision and potency of paclitaxel, a well-known chemotherapy drug, providing a more effective and tolerable treatment option for patients.

What evidence suggests that FID-007 might be an effective treatment for head and neck cancer?

Research shows that paclitaxel, the main ingredient in FID-007, is a well-known chemotherapy drug that kills cancer cells. In this trial, participants will receive FID-007, which uses a special coating called PEOX. This coating may help the drug target tumors more effectively while sparing healthy cells, potentially enhancing the drug's efficacy and reducing side effects. Studies on similar treatments have shown that 14% to 27% of patients experience tumor shrinkage. Although limited data exists on FID-007 itself, it is designed to improve treatment outcomes for head and neck cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Jacob Thomas, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for individuals with head and neck cancers, specifically squamous cell carcinoma. Participants should be candidates for surgery to remove their tumor. The study aims to understand how a new form of chemotherapy (FID-007) affects immune cells around the tumor before standard surgery.

Inclusion Criteria

Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 X institutional upper limit of normal

Creatinine ≤ 1.5 X institutional upper limit of normal

My cancer is confirmed as head and neck squamous cell carcinoma.

Exclusion Criteria

I have been treated with taxane chemotherapies before.

My cancer originated in the nasopharynx, salivary gland, or skin.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to FID-007 or other agents used in study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive FID-007 intravenously over 30 minutes once a week for 3 weeks on days 1, 8, and 15 of a single 28 day cycle

4 weeks

3 visits (in-person)

Surgery

Participants undergo standard of care surgery approximately 3-6 weeks after the last dose of FID-007

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 3 months for 2 years

24 months

8 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PEOX-based Polymer Encapsulated Paclitaxel FID-007
• Tumor Resection

Trial Overview The trial tests FID-007, a PEOX-polymer encapsulated paclitaxel designed to target tumors more effectively while sparing normal cells. It's given before surgery, followed by imaging studies like CT and MRI, then surgical removal of the tumor and collection of tissue samples.

How Is the Trial Designed?

Group I: Treatment (FID-007) Experimental Treatment 5 Interventions

Patients receive FID-007 IV over 30 minutes once a week for 3 weeks on days 1, 8, and 15 of a single 28 day cycle in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Patients undergo CT or MRI during screening and blood sample collection throughout the study.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a phase II trial involving 30 patients with recurrent head and neck cancer, high-dose paclitaxel (250 mg/m2) demonstrated a 40% response rate, indicating its potential effectiveness as a treatment option.

The main side effects observed were neutropenia, peripheral neuropathy, and arthralgias/myalgias, which are consistent with previous studies, suggesting that while paclitaxel is promising, careful monitoring for these toxicities is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel (Taxol) for the treatment of head and neck cancer. Forastiere, AA.[2015]

The biodegradable polyanhydride polymer loaded with chemotherapy drugs demonstrated effective and sustained release of anticancer agents, with over 95% of methotrexate and fluorouracil released within 10 days, showing potential for targeted treatment of squamous cell carcinomas (SCCs).

In both in vitro and in vivo studies, the polymer-drug combination significantly inhibited tumor growth in human SCC models, achieving up to 96.6% cell death in culture and a substantial reduction in tumor size in nude mice, indicating its efficacy as a promising therapeutic option for head and neck cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polymer chemotherapy for head and neck cancer. Shikani, AH., Domb, AJ.[2013]

Paclitaxel shows promising activity against squamous cell carcinoma of the head and neck, with preliminary results from a phase II trial indicating two complete and seven partial responses among 19 patients.

While paclitaxel is effective, it is associated with significant toxicities, including grades 3 and 4 neutropenia and grades 1 and 2 neuropathy, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of paclitaxel (Taxol) in squamous cell carcinoma of the head and neck. Forastiere, AA.[2015]

In a Phase II trial involving 30 patients with recurrent head and neck cancer, high-dose paclitaxel (250 mg/m2) showed a 40% overall response rate, indicating its potential effectiveness in treating this type of cancer.

The treatment was associated with significant toxicities, including severe neutropenia in 91% of patients, highlighting the need for careful monitoring and management of side effects during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future trials of Taxol (paclitaxel) in head and neck cancer. Forastiere, AA.[2016]

In a study involving 65 patients with recurrent or metastatic head and neck cancer, the combination of paclitaxel, ifosfamide, and cisplatin showed a promising overall response rate of 55%, with 16% achieving complete responses and 39% partial responses.

The treatment regimen was well tolerated and resulted in a median survival of 8.9 months, suggesting significant antitumor activity and potential for further testing as an induction therapy in advanced cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in paclitaxel-containing chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck. Shin, DM., Glisson, BS., Khuri, FR., et al.[2015]

The amphiphilic block copolymer PEO-PBO effectively forms nanoparticles for delivering the cancer drug paclitaxel, with a size of approximately 92.71 nm, which is suitable for targeting tumors due to the enhanced permeability and retention effect.

PEO-PBO nanoparticles demonstrated superior pharmacokinetics, biodistribution, and tumor inhibition compared to the commonly used PEG-PDLLA, along with better biocompatibility and stability, indicating its potential as a promising drug delivery system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of paclitaxel using nanoparticles composed of poly(ethylene oxide)-b-poly(butylene oxide) (PEO-PBO). Wang, L., Yao, J., Zhang, X., et al.[2018]

A regimen of concurrent chemoradiotherapy using a 120-hour infusion of paclitaxel resulted in a median survival of 56.5 months for patients with locally advanced squamous cell carcinoma of the head and neck, indicating effective long-term local control.

While the treatment was effective, it was associated with significant long-term toxicities, including hypothyroidism in 43% of patients, and complications such as xerostomia and esophageal strictures, though most toxicities were mild (grade 1 or 2).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes and toxicity of concurrent paclitaxel and radiotherapy for locally advanced head-and-neck cancer. Citrin, D., Mansueti, J., Likhacheva, A., et al.[2021]

The study developed a polymeric nanocarrier system for delivering paclitaxel (PTX) directly into tumors, which showed significantly higher antitumor efficacy and improved safety compared to free PTX in a mouse model of hypopharynx carcinoma.

PTX-loaded nanoparticles reduced tumor growth and markers of cell proliferation and angiogenesis, indicating that this targeted delivery method enhances the therapeutic effects of PTX while minimizing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel-loaded polymeric nanoparticles based on α-tocopheryl succinate for the treatment of head and neck squamous cell carcinoma: in vivo murine model. Riestra-Ayora, J., Sánchez-Rodríguez, C., Palao-Suay, R., et al.[2022]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.6042

Efficacy from the phase 1 study of FID-007, a novel ... Taxanes in this setting have historically demonstrated response rates around 14-27%. FID-007 (FID) consists of paclitaxel encapsulated in a ...

2. cancer.gov cancer.gov/clinicaltrials/NCI-2024-01367

FID-007 Followed by Standard of Care Surgery in Head ... This phase I trial studies how the PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) affects the immune cells around the tumor patients with head ...

3. trialx.com trialx.com/clinical-trials/listings/291342/fid-007-followed-by-standard-of-care-surgery-in-head-and-neck-cancer/

FID-007 Followed by Standard of Care Surgery in Head ... FID-007 is a packaged form of paclitaxel using a polyethylozaxoline (PEOX) polymer which may allow the drug to reach deeper into tumors and less into normal ...

4. withpower.com withpower.com/trial/phase-1-head-and-neck-neoplasms-3-2024-ac2d3

FID-007 for Head and Neck Cancer · Info for Participants This phase I trial studies on how the PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) affects the immune cells around the tumor patients with ...

5. ir.fulgentgenetics.com ir.fulgentgenetics.com/news-releases/news-release-details/fulgent-announces-upcoming-presentation-clinical-data-its-lead-0

Release Details FID-007 consists of paclitaxel encapsulated in a polyethyloxazoline (PEOX) polymer excipient designed to enhance PK, biodistribution, and tolerability. In ...

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/473915

FID-007 and Cetuximab in Treating Patients With Advanced ... 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 ...

7. withpower.com withpower.com/trial/phase-2-squamous-cell-carcinoma-of-head-and-neck-2-2024-dadb2

FID-007 + Cetuximab for Head and Neck Cancer Research shows that cetuximab, when combined with paclitaxel, has been effective in treating head and neck cancer, improving survival rates and disease control.