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

Primary Purpose

Head and Neck Squamous Cell Carcinoma, Oral Mucositis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MIT-001 plus CCRT
Sponsored by
MitoImmune Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Squamous Cell Carcinoma focused on measuring MIT-001, Oral Mucositis, OM, NecroX-7, CCRT-associated OM, CCRT-induced OM, Mitochondria-targeted, ROS scavenger

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Banner MD Anderson Cancer CenterRecruiting
  • Norris Comprehensive Cancer CenterRecruiting
  • Cancer Center of KansasRecruiting
  • Washington University School of Medicine Siteman Cancer Center
  • James P. Wilmot Cancer CenterRecruiting
  • Wake Forest Baptist Health - Comprehensive Cancer CenterRecruiting
  • James Cancer Hospital Solove Research InstituteRecruiting
  • University of Pittsburgh Medical Center - Hillman Cancer Center
  • The Catholic University of Korea Saint Vincent's HospitalRecruiting
  • Jeonbuk National University HospitalRecruiting
  • Keimyung University Dongsan HospitalRecruiting
  • Chungnam National University HospitalRecruiting
  • National Cancer CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Inha University HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Korea University Guro HospitalRecruiting
  • Hanyang University Seoul HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

20 mg

40 mg

60 mg

Placebo

Arm Description

MIT-001 20 mg

MIT-001 40 mg

MIT-001 60 mg

Matching placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of OM
Incidence of OM of each Grade (WHO criteria)
Time to onset of severe OM
Time to onset of severe OM, defined as Grade 3 or higher (WHO criteria)
Mouth pain and discomfort
Patient-reported mucositis-related mouth pain and discomfort
Analgesic use for OM
Frequency and Cumulative dose (in morphine mg equivalent)

Full Information

First Posted
November 26, 2020
Last Updated
April 21, 2023
Sponsor
MitoImmune Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04651634
Brief Title
MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients
Acronym
MIT-001
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MitoImmune Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
20 mg
Arm Type
Experimental
Arm Description
MIT-001 20 mg
Arm Title
40 mg
Arm Type
Experimental
Arm Description
MIT-001 40 mg
Arm Title
60 mg
Arm Type
Experimental
Arm Description
MIT-001 60 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
MIT-001 plus CCRT
Intervention Description
MIT-001 IV-infusion plus CCRT
Primary Outcome Measure Information:
Title
Incidence of severe OM
Description
severe OM (WHO criteria Grade 3 or higher) at a cumulative radiation dose of 60 Gy
Time Frame
From first treatment to 2 months of safety follow-up period after CCRT completion
Secondary Outcome Measure Information:
Title
Incidence of OM
Description
Incidence of OM of each Grade (WHO criteria)
Time Frame
From first treatment to 2 months of short-term safety follow-up period after CCRT completion
Title
Time to onset of severe OM
Description
Time to onset of severe OM, defined as Grade 3 or higher (WHO criteria)
Time Frame
From first treatment to 2 months of short-term safety follow-up period after CCRT completion
Title
Mouth pain and discomfort
Description
Patient-reported mucositis-related mouth pain and discomfort
Time Frame
From first treatment to 2 months of short-term safety follow-up period after CCRT completion
Title
Analgesic use for OM
Description
Frequency and Cumulative dose (in morphine mg equivalent)
Time Frame
From first treatment to 2 months of short-term safety follow-up period after CCRT completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinsang Jung
Phone
+82 2 6933 6727
Email
jinsang.jung@mitoimmune.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinsang Jung, M.Pharm
Organizational Affiliation
MitoImmune Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Walker, M.D.
Facility Name
Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Thomas, M.D.
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaker Dakhil, M.D.
Facility Name
Washington University School of Medicine Siteman Cancer Center
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Withdrawn
Facility Name
James P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Cummings, M.D.
Facility Name
Wake Forest Baptist Health - Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Hughes, M.D.
Facility Name
James Cancer Hospital Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sujith Baliga, M.D.
Facility Name
University of Pittsburgh Medical Center - Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
17109
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Catholic University of Korea Saint Vincent's Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Jung An, M.D.
Facility Name
Jeonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-Kee Song, M.D.
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keon Uk Park, M.D.
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myungwon Lee, MD
Facility Name
National Cancer Center
City
Goyang-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wonyoung Choi, M.D.
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keun-Wook Lee, M.D.
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong-Seok Choi, MD
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03082
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong-Gyun Wu, M.D.
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-Joo Kang, M.D.
Facility Name
Hanyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hae Jin Park, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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