MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients

• Status: Not yet recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy and safety of three different doses of MIT-001 compared to the placebo in prevention of oral mucositis (OM) in patients with HNSCC who are undergoing concurrent chemoradiotherapy (CCRT).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MitoImmune Therapeutics

Criteria

Inclusion Criteria:

• 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

• 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, α/β 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.

• CCRT plan to receive standard cisplatin monotherapy: Standard cisplatin monotherapy administered weekly (30 to 40 mg/m2), once per week for 5 to 7 continuous weeks.

• Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 1 or less

• Serum pregnancy test negative for women of childbearing potential (woman of childbearing potential [WOCBP]

Exclusion Criteria:

• Patients who have active mucositis at screening.

• Planned to receive Erbitux™ (Cetuximab) or other targeted or immune therapy during the study.

• Tumor of the lips, sinuses, or salivary glands or unknown primary tumors.

• Metastatic disease (M1) Stage.

• Known history of severe vascular toxicity or allergies or intolerance to cisplatin and similar platinum-containing compounds.

• Any clinically significant and/or active infection, other systemic illness or condition (other than HNSCC) that would preclude them from participating in the study in the opinion of the Investigator.