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

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).