None listed
Conditions
Interventions
Drug : MIT-001 or placebo
Dose: 20, 40, or 60 mg
Administration route and frequency: Two times per week, 30-minute intravenous infusion
Treatment period: For 5 to 7 continuous weeks (with a cumulative
Sponsors
MitoImmune Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older, as required, to be legally considered an ADULT, at the time of signing the informed consent 2. Histologically confirmed HNSCC (The American joint committee on cancer [AJCC] 8th edition, Stage II, III, IVA, or IVB), involving either the oral cavity or oropharynx 3. Treatment plan to receive a continuous course of intensity-modulated radiation therapy (IMRT) for definitive treatment of HNSCC delivered as single daily fractions of 1.8 to 2.5 Gy with a cumulative radiation dose between 60 and 72 Gy (EQD2 of 60 to 72 Gy, a/ß ratio=10): Planned radiation treatment fields must include at least 30% of oral cavity that are planned to receive a total of 50 Gy or higher 4. CCRT plan to receive standard cisplatin monotherapy: Standard cisplatin monotherapy administered weekly (30 to 40 mg/m^2), once per week for 5 to 7 continuous weeks 5. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 1 or less 6. Adequate hematologic function as indicated by: - Absolute neutrophil count (ANC): 1500/mm^3 or higher - Hemoglobin (Hb): 9.0 g/dL or higher - Platelet (PLT) count: 100,000/mm^3 or higher 7. Adequate renal and liver function as indicated by: - Serum total bilirubin: 1.5 x upper limit of normal (ULN) or less - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT): 2.5 x upper limit of normal (ULN) or less - Alkaline phosphatase (ALP): 2.5 x upper limit of normal (ULN) or less - Serum creatinine (S-Cr) level acceptable for treatment with cisplatin per institutional guidelines 8. Serum pregnancy test negative for women of childbearing potential 9. Males and females must agree to use effective contraception starting prior to the first day of treatment and continuing for 30 days after the last dose of MIT-001 10. Patients who voluntarily join for participation in the study, sign the informed consent form (ICF) and are willing to comply the clinical study procedures
Exclusion criteria
Exclusion criteria: 1. Patients who have active mucositis at screening 2. Planned to receive Erbitux™ (Cetuximab) or other targeted or immune therapy during the study 3. Tumor of the lips, sinuses, or salivary glands or unknown primary tumors 4. Metastatic disease (M1) Stage 5. Known history of severe vascular toxicity or allergies or intolerance to cisplatin and similar platinum-containing compounds 6. Any clinically significant and/or active infection, other systemic illness or condition (other than head and neck squamous cell carcinoma) that would preclude them from participating in the study in the opinion of the Investigator 7. Prior radiotherapy to head and neck region 8. Prior resective surgery for primary tumor under treatment for head and neck squamous cell carcinoma 9. Planned concomitant use of medications known to affect cytochrome P450 (CYP) enzyme activity or inhibit organic anion transporting polypeptide (OATP) 10. Patient in any study involving administration of an investigational agent within 30 days of randomization into the study 11. Female patients who are pregnant or breastfeeding 12. Patient has a positive reverse transcription polymerase chain reaction (RT-PCR) test for SARS-CoV-2 prior to randomization 13. Patient has clinical signs and symptoms consistent with SARS-CoV-2 infection; e.g., fever, dry cough, dyspnea, sore throat, fatigue, or positive SARS-CoV-2 test result within 2 weeks prior to screening 14. Patient who had severe course of COVID-19 (extracorporeal membrane oxygenation [ECMO], mechanically ventilated) 15. Recent (within previous 14 days) exposure to someone who has COVID-19 symptoms or positive test result 16. Recent (within previous 14 days) visit to the ward of a healthcare facility where COVID-19 patients are being treated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe oral mucositis (WHO criteria Grade 3 or higher) at a cumulative radiation dose of 60 Gy (5 to 7 weeks after the initiation of radiotherapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of oral mucosits of each Grade (WHO criteria) at a cumulative radiation dose of 60 Gy;Time to onset of severe oral mucositis, defined as Grade 3 or higher (WHO criteria);Duration of severe oral mucositis (WHO criteria);Cumulative radiation dose at time of severe oral mucositis (WHO criteria);Patient-reported mucositis-related mouth pain and discomfort;Analgesic use for oral mucositis (frequency of use, cumulative dose (in morphine mg equivalent));Frequency of radiotherapy treatment interruptions;The proportion of subjects who experience Grade 4 or higher grades of adverse event or study drug-related adverse event (NCI CTCAE version 5.0);Single dosing (Day 1) and multiple dosing (Day 15) serum pharmacokinetic parameters | — |
Countries
Korea, Republic of
Contacts
Public ContactMyung-Ju Ahn
Samsung Medical Center
Outcome results
None listed