Intratumoral Microdosing of TAK-981 in Head and Neck Cancer

Exclusion Criteria

• •1. Tumors or effaced nodes that are anticipated by the Investigator to lack a sufficient volume of viable tumor tissue (based on available pre-operative imaging, pre-injection ultrasound imaging, or pathology reports) for CIVO injection due to size, location, necrosis, cysts, excessive stroma, fibrosis, or treatment-induced tissue changes. Lesions that have received neoadjuvant radiation therapy may lack sufficient viable tumor tissue for CIVO injection procedures.
• •2. Patients who have received prior treatment with cetuximab or immune checkpoint inhibitors.
• •3. Female patients who are both lactating and breastfeeding or have a positive serum pregnancy during the screening period or a positive urine pregnancy test on Day 1 before the tumor injection procedure.
• •4. Any uncontrolled intercurrent illness, condition, serious medical or psychiatric illness, or circumstance that, in the opinion of the Investigator, could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives.
• •5. Patients with uncontrolled autoimmune diseases requiring treatment.
• •6. Patients with human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) with uncontrolled viral load and CD4 (Cluster of Differentiation 4) less than 200.
• •7. Patients that have received a live vaccine within 4 weeks of the baseline/screening visit.
• •8. Patients with a sensitivity to Captisol.
• •9. Use of any of the following ≤ 2 weeks prior to CIVO injection:
• •1. Immunosuppressive drugs (e.g., calcineurin inhibitors)
• •2. Biological response modifiers for autoimmune disease
• •3. Systemic glucocorticoids: oral or parenteral corticosteroids at a dose ≥ 20 mg/day prednisone, or equivalent Note: physiologic replacement dosing of steroids (≤ 3mg/m2/d prednisone or equivalent), low-dose corticosteroids for dye allergies prior to staging scans or use in anti-emetic prophylaxis for patients undergoing chemotherapy, or topical steroids, are allowed
• •4. Hematopoietic growth factors