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

NCT04651634 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MIT001-OM-01
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 16

Brief 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).

Conditions

Head and Neck Squamous Cell Carcinoma; Oral Mucositis

Keywords

MIT-001; Oral Mucositis; OM; NecroX-7; CCRT-associated OM; CCRT-induced OM; Mitochondria-targeted; ROS scavenger

Outcome Measures

Primary Outcomes (1)

• Incidence of severe OM

  severe OM (WHO criteria Grade 3 or higher) at a cumulative radiation dose of 60 Gy

  From first treatment to 2 months of safety follow-up period after CCRT completion

Secondary Outcomes (4)

• Incidence of OM

  From first treatment to 2 months of short-term safety follow-up period after CCRT completion

• Time to onset of severe OM

  From first treatment to 2 months of short-term safety follow-up period after CCRT completion

• Mouth pain and discomfort

  From first treatment to 2 months of short-term safety follow-up period after CCRT completion

• Analgesic use for OM

  From first treatment to 2 months of short-term safety follow-up period after CCRT completion

Study Arms (4)

20 mg

EXPERIMENTAL

MIT-001 20 mg

Drug: MIT-001 plus CCRT

40 mg

EXPERIMENTAL

MIT-001 40 mg

Drug: MIT-001 plus CCRT

60 mg

EXPERIMENTAL

MIT-001 60 mg

Drug: MIT-001 plus CCRT

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: MIT-001 plus CCRT

Interventions

MIT-001 plus CCRT DRUG

MIT-001 IV-infusion plus CCRT

20 mg; 40 mg; 60 mg; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[WOCBP\]

You may not qualify if:

• 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.

Sponsors & Collaborators

• MitoImmune Therapeutics: lead

Study Sites (16)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67208, United States

Location

James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

Wake Forest Baptist Health - Comprehensive Cancer Center

Winston-Salem, North Carolina, 27103, United States

Location

James Cancer Hospital Solove Research Institute

Columbus, Ohio, 43210, United States

Location

The Catholic University of Korea Saint Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

National Cancer Center

Goyang-si, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Seoul National University Hospital

Seoul, 03082, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Hanyang University Seoul Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Stomatitis

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jinsang Jung, M.Pharm

  MitoImmune Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study design will minimize bias and provide reference data (i.e., data from placebo treated subjects) which will aid in the interpretation of results. To limit the occurrence of conscious and unconscious bias in the conduct and interpretation of safety and efficacy results, the study is double blind where the subject, the Investigators/site staff, and the Sponsor staff remain unaware of the treatment assignment. The planned safety assessments that will be performed during the study are considered acceptable measures for ensuring the safety of subjects during a clinical study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The three active treatment groups will receive either 20, 40, and 60 mg/day of MIT-001 IV infusion for 30 minutes, two times per week for 5 to 7 continuous weeks until a cumulative radiation dose of between 60 and 72 Gy, with CCRT. Placebo group will receive placebo, manufactured with the same properties and appearance as MIT 001, at same treatment frequency as MIT-001 with CCRT.

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: June 21, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); KR (10)