Phase 2a Study to Evaluate Suppression of Radiotherapy-induced Mucositis by TK112690

Inclusion Criteria

• •Participants must meet ALL of the following criteria at the time of screening unless otherwise specified:
• •1. Patient must sign study specific informed consent prior to study entry.
• •2. Male or Female patient aged 18 - 75 years.
• •3. Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oral cavity (Refer Definition in 10.13.1), oropharynx or hypopharynx.
• •4. Patients must have at least 1 mucosal site of the oral cavity/oropharynx/hypopharynx mucosa assessable by visual transoral inspection that will receive cumulative radiation dose of 70 Gy.
• •Note: Unavoidable doses of at least 60 Gy, to include entrance, exit, and scatter doses, still constitutes planned radiation.
• •5. Patients with tumors of the larynx or hypopharynx are eligible only if it is anticipated that at least 1 index site in the oral cavity/oropharynx/hypopharynx mucosa (Refer section 10.13.1) will receive cumulative radiation dose of 70 Gy.
• •6. Selected Stage I to III or IVA-B per AJCC, Cancer Imaging Manual, 8th edition, at study entry, including no distant metastases other than non- metastatic SCCHN, based upon the following minimum diagnostic workup:
• •* History/physical examination, including documentation of tobacco/alcohol use and current medications (including opioids/dosing), within 8 weeks prior to randomization.
• •* Chest CT scan within 8 weeks prior to randomization.
• •* MRI or CT scan with contrast of tumor site within 8 weeks prior to randomization.
• •7. Mucositis Grade ≤ 1 per WHO Scale and Xerostomia of Grade ≤ 2 per CTCAE version 5.0
• •8. ECOG Performance Status ≤ 2.
• •9. Adequate bone marrow function as per CTCAE V 5, defined as follows (within 2 weeks prior to randomization):
• •* Absolute neutrophil count ≥ 1500cells/mm3 based upon CBC/differential obtained within 2 weeks prior to randomization.
• •* Platelets ≥ 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to randomization.
• •* Hemoglobin ≥ 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to randomization (Note: The use of transfusion or other intervention to achieve Hgb\> 8.0 g/dl is acceptable).
• •10. Adequate hepatic function with bilirubin ≤ 1.5 x upper-normal limit (ULN), AST or ALT ≤3 x ULN within 2 weeks prior to randomization.
• •11. Adequate renal function with serum creatinine \< 1.5 mg/dl and creatinine clearance (CrC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula. CrC male = \[(140 - age) x (wt in kg)\] / \[(Serum Cr mg/dl) x (72)\]. CrC female = 0.85 x (CrCl male) within 2 weeks prior to randomization.
• •12. Normal serum calcium or normal corrected serum calcium within 2 weeks prior to randomization; formula for corrected calcium if albumin valued is below normal range: Corrected calcium (mg/dl) = (4 - \[Patient's albumin (g/dl)\] x 0.8) + Patient's measured calcium (mg/dl).
• •13. Negative serum pregnancy test for women of childbearing potential.
• •14. Women of childbearing potential and male participants with female partners of childbearing potential must practice adequate contraception.