Clinical Trial 23276

• Overview

  Study 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

  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).

  Objective:

  Primary Objective: * To evaluate 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 (ORR) Secondary Objectives: * To evaluate the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic HNSCC 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 safety and tolerability of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic HNSCC * To characterize the pharmacokinetics (PK) of FID-007 and its metabolites (6-a-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

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunotherapy

  Medications:

  Cetuximab (); Erbitux (Cetuximab); FID-007 ()

• Inclusion Criteria

  Inclusion Criteria:
  • Ability to understand and willingness to provide informed consent before the start of any study-specific procedures.
  • Age 18 years or older.
  • 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 more, 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.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score (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 or less (except for alopecia) according to NCI CTCAE version 5.0.
  • Adequate bone marrow and organ function.
  • 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.

• Exclusion Criteria

  Exclusion Criteria:
  • 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 > 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 or more 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).

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