MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients
NCT ID: NCT04651634
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2021-06-21
2025-12-31
Brief Summary
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Detailed Description
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MitoImmune Therapeutics Inc. (hereafter referred to as Sponsor) has developed MIT-001 which can scavenge abnormal levels of reactive oxygen species (ROS), enabling the cells to retain mitochondrial membrane permeability and mitochondrial function. This eventually inhibits additional ROS production, indicating that MIT-001 can prevent excessive inflammation caused by ROS. In addition, MIT-001 may possibly 1) block inflammatory cytokine production via inhibiting nuclear factor kappa B (NF kB) or inflammasome dependent pathways, 2) inhibit necrosis/necroptosis via blocking high mobility group box 1 (HMGB1) mediated cytokine production, and 3) balance regulation between T helper type 1/17 (Th1/17) and regulatory T cells.
Based on the pathophysiological progression of CCRT-associated OM, initiated by direct injury to basal epithelial cells which experience deoxyribonucleic acid (DNA) damage and increased ROS levels, Sponsor expects the prevention of OM in patients receiving CCRT of locally advanced HNSCC with MIT 001 by effectively scavenging increased ROS induced by CCRT.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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20 mg
MIT-001 20 mg
MIT-001 plus CCRT
MIT-001 IV-infusion plus CCRT
40 mg
MIT-001 40 mg
MIT-001 plus CCRT
MIT-001 IV-infusion plus CCRT
60 mg
MIT-001 60 mg
MIT-001 plus CCRT
MIT-001 IV-infusion plus CCRT
Placebo
Matching placebo
MIT-001 plus CCRT
MIT-001 IV-infusion plus CCRT
Interventions
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MIT-001 plus CCRT
MIT-001 IV-infusion plus CCRT
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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MitoImmune Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Jinsang Jung, M.Pharm
Role: STUDY_DIRECTOR
MitoImmune Therapeutics
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Norris Comprehensive Cancer Center
Los Angeles, California, United States
Cancer Center of Kansas
Wichita, Kansas, United States
James P. Wilmot Cancer Center
Rochester, New York, United States
Wake Forest Baptist Health - Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
James Cancer Hospital Solove Research Institute
Columbus, Ohio, United States
The Catholic University of Korea Saint Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
National Cancer Center
Goyang-si, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Inha University Hospital
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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MIT001-OM-01
Identifier Type: -
Identifier Source: org_study_id
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