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

April 21, 2023 updated by: MitoImmune Therapeutics

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Oral mucositis associated with cancer therapy carries a significant morbidity. OM is a common complication in patients receiving CCRT used for treating HNSCC. Mucositis lesions can be painful, affect nutrition and quality of life (QoL), and have a significant economic impact. However, a definitive intervention regime has not been established. Therefore, it is essential to develop appropriate treatment.

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Recruiting
        • Keimyung University Dongsan Hospital
        • Contact:
          • Keon Uk Park, M.D.
      • Daejeon, Korea, Republic of
        • Recruiting
        • Chungnam National University Hospital
        • Contact:
          • Myungwon Lee, MD
      • Goyang-si, Korea, Republic of
        • Recruiting
        • National Cancer Center
        • Contact:
          • Wonyoung Choi, M.D.
      • Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Keun-Wook Lee, M.D.
      • Incheon, Korea, Republic of
        • Recruiting
        • Inha University Hospital
        • Contact:
          • Jeong-Seok Choi, MD
      • Seoul, Korea, Republic of, 08308
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
          • Eun-Joo Kang, M.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Hanyang University Seoul Hospital
        • Contact:
          • Hae Jin Park, MD
      • Seoul, Korea, Republic of, 03082
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Hong-Gyun Wu, M.D.
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16247
        • Recruiting
        • The Catholic University of Korea Saint Vincent's Hospital
        • Contact:
          • Ho Jung An, M.D.
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
        • Recruiting
        • Jeonbuk National University Hospital
        • Contact:
          • Eun-Kee Song, M.D.
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center
        • Contact:
          • Gary Walker, M.D.
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Norris Comprehensive Cancer Center
        • Contact:
          • Jacob Thomas, M.D.
    • Kansas
      • Wichita, Kansas, United States, 67208
        • Recruiting
        • Cancer Center of Kansas
        • Contact:
          • Shaker Dakhil, M.D.
    • Missouri
      • Saint Peters, Missouri, United States, 63110
        • Withdrawn
        • Washington University School of Medicine Siteman Cancer Center
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • James P. Wilmot Cancer Center
        • Contact:
          • Michael Cummings, M.D.
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Wake Forest Baptist Health - Comprehensive Cancer Center
        • Contact:
          • Ryan Hughes, M.D.
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • James Cancer Hospital Solove Research Institute
        • Contact:
          • Sujith Baliga, M.D.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 17109
        • Withdrawn
        • University of Pittsburgh Medical Center - Hillman Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Drug: MIT-001 plus CCRT
MIT-001 IV-infusion plus CCRT
Experimental: 20 mg
MIT-001 20 mg
Drug: MIT-001 plus CCRT
MIT-001 IV-infusion plus CCRT
Experimental: 40 mg
MIT-001 40 mg
Drug: MIT-001 plus CCRT
MIT-001 IV-infusion plus CCRT
Experimental: 60 mg
MIT-001 60 mg
Drug: MIT-001 plus CCRT
MIT-001 IV-infusion plus CCRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of severe OM
Time Frame: From first treatment to 2 months of safety follow-up period after CCRT completion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of OM
Time Frame: From first treatment to 2 months of short-term safety follow-up period after CCRT completion
Incidence of OM of each Grade (WHO criteria)
From first treatment to 2 months of short-term safety follow-up period after CCRT completion
Time to onset of severe OM
Time Frame: From first treatment to 2 months of short-term safety follow-up period after CCRT completion
Time to onset of severe OM, defined as Grade 3 or higher (WHO criteria)
From first treatment to 2 months of short-term safety follow-up period after CCRT completion
Mouth pain and discomfort
Time Frame: From first treatment to 2 months of short-term safety follow-up period after CCRT completion
Patient-reported mucositis-related mouth pain and discomfort
From first treatment to 2 months of short-term safety follow-up period after CCRT completion
Analgesic use for OM
Time Frame: From first treatment to 2 months of short-term safety follow-up period after CCRT completion
Frequency and Cumulative dose (in morphine mg equivalent)
From first treatment to 2 months of short-term safety follow-up period after CCRT completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MitoImmune Therapeutics

Investigators

  • Study Director: Jinsang Jung, M.Pharm, MitoImmune Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2021

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

November 26, 2020

First Submitted That Met QC Criteria

November 26, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIT001-OM-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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