Clinical trial · Interventional
MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients
A Phase 2, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of MIT-001 in Prevention of Oral Mucositis in Patients Receiving CCRT for Locally Advanced HNSCC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MIT-001 plus CCRT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 20 mg
- description
- MIT-001 20 mg
- interventionNames
- Drug: MIT-001 plus CCRT
- type
- EXPERIMENTAL
- label
- 40 mg
- description
- MIT-001 40 mg
- interventionNames
- Drug: MIT-001 plus CCRT
- type
- EXPERIMENTAL
- label
- 60 mg
- description
- MIT-001 60 mg
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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, or HPV-positive Stage I oropharyngeal cancer. * 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. * Prior resective surgery (4 weeks or less than 4 weeks from receiving surgery to randomization) for primary tumor under treatment for HNSCC.
References
Publications (0)
Data not yet available