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Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors (MYE Symphony)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05969041
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : January 18, 2024
Sponsor:
Information provided by (Responsible Party):
Myeloid Therapeutics

Tracking Information
First Submitted Date  ICMJE July 6, 2023
First Posted Date  ICMJE August 1, 2023
Last Update Posted Date January 18, 2024
Actual Study Start Date  ICMJE August 2, 2023
Estimated Primary Completion Date August 31, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2023)
  • To evaluate the safety and tolerability of MT-302 through incidence of Adverse Events [ Time Frame: Up to Week 20 ]
    Adverse Events will be graded according to the NCI-CTCAE, version 5.0
  • To establish the maximum tolerated dose (MTD) [ Time Frame: Up to Week 20 ]
    based on dose limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2023)
  • To further characterize the safety of MT-302 through incidence of Adverse Events [ Time Frame: Up to Week 20 ]
    Adverse Events will be graded according to the NCI-CTCAE, version 5.0
  • To assess the pharmacokinetics (PK) of MT-302 [ Time Frame: Up to Week 20 ]
    PK parameter: Plasma concentrations
  • To assess the pharmacokinetics (PK) of MT-302 [ Time Frame: Up to Week 20 ]
    PK parameter: Area under curve (AUC0-last, AUC 0-∞)
  • To assess the pharmacokinetics (PK) of MT-302 [ Time Frame: Up to Week 20 ]
    PK parameter: Time of maximum observed plasma concentration (tmax)
  • To assess the pharmacokinetics (PK) of MT-302 [ Time Frame: Up to Week 20 ]
    PK parameter: Apparent terminal Half-life (t1/2)
  • To assess the pharmacokinetics (PK) of MT-302 [ Time Frame: Up to Week 20 ]
    PK parameter: Plasma Clearance (CL)
  • To assess the pharmacokinetics (PK) of MT-302 [ Time Frame: Up to Week 20 ]
    PK parameter: Volume of Distribution (Vd)
  • To assess the pharmacokinetics (PK) of MT-302 [ Time Frame: Up to Week 20 ]
    PK parameter:Mean residence time (MRT)
  • To assess the pharmacokinetics (PK) of MT-302 [ Time Frame: Up to Week 20 ]
    PK parameter: terminal rate constant ( λz)
  • Determine rate of ICANS [ Time Frame: Up to Week 20 ]
    For grading of potential immune effector cell-associated neurotoxicity syndrome (ICANS), use of the 10-point immune effector cell-associated encephalopathy (ICE) screening tool
  • Determine rate of Grade 3-5 CRS [ Time Frame: Up to Week 20 ]
    ASCO CRS Grading
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
Official Title  ICMJE MYE Symphony: A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
Brief Summary MYE Symphony is a multicenter, open-label, Phase 1 first-in-human study to assess the safety, tolerability, and define the RP2D of MT-302 in participants with advanced epithelial cancer.
Detailed Description

The study has 4 Cohorts. Each Cohort has 4 Cycles. For Cohorts 1-3, the dosing regimen will be every 14 days for 3 doses, followed by administration once every 28 days for three doses. For Cohort 4, the dosing regimen will be modified. Participants will receive one dose of MT-302 every week for 3 doses, followed by administration once every 28 days for three additional doses.

A Safety Review Committee (SRC) will provide oversight for this study. The primary responsibility of the SRC is to safeguard study participants by reviewing and assessing the clinical safety data being collected during the conduct of the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epithelial Tumors, Malignant
Intervention  ICMJE Drug: MT-302 (A)
MT-302 is an investigational drug
Study Arms  ICMJE Experimental: A (MT-302)
Participants will receive MT-302 through intravenous infusion.
Intervention: Drug: MT-302 (A)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 28, 2023)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2028
Estimated Primary Completion Date August 31, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults age ≥ 18 inclusive at the time the Informed Consent Form (ICF) is signed.
  2. Histologically proven, metastatic or advanced epithelial cancer including the following cancer types:

    1. Urothelial
    2. Cervical
    3. Ovarian epithelial
    4. Triple-negative breast
    5. HR+/HER2- breast
    6. Pancreatic ductal adenocarcinoma
    7. Gastric adenocarcinoma
    8. Esophageal carcinoma
    9. Non-small cell lung
    10. Colorectal
  3. Progressive disease at baseline, refractory or relapsed to standard of care or who have declined standard therapy.
  4. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria v 1.1.
  5. Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1.
  6. Life expectancy of > 12 weeks.
  7. Echocardiogram (ECHO) or multiple gated acquisition scan showing an ejection fraction greater than or equal to 50%.
  8. Electrocardiogram (ECG) showing no clinically significant abnormality at Screening or showing an average QTc interval < 450 msec in males and < 470 msec in females (< 480 msec for participants with bundle branch block). Either Fridericia's or Bazett's formula may be used to correct the QT interval.
  9. Oxygen saturation of greater than or equal to 90% on room air measured by pulse oximetry.
  10. Adequate organ function as defined by laboratory values at Screening.
  11. Willing and able to provide written informed consent.
  12. Willing to perform and comply with all study procedures including undergoing study-related biopsies and attending clinic visits as scheduled.
  13. Men must abstain from sperm donation during study treatment or for 4 months following last dose of study treatment.
  14. Men and WOCBP must be willing to practice a highly effective method of contraception.

Exclusion Criteria:

  1. Known active CNS metastasis and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression for at least 4 weeks by repeat imaging), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study intervention.
  2. Pregnant or nursing women.
  3. Must be > 28 days beyond major surgery, including hepatectomy or joint replacement.
  4. Prior allogeneic bone marrow transplantation or solid organ transplant.
  5. Spinal cord compression not definitively treated with surgery and/or radiation.
  6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
  7. Any acute illness including fever (> 100.4° F or > 38° C) within 7 days prior to Day 1
  8. Active systemic bacterial, fungal, or viral infection within 7 days prior to Day 1. Participant cannot have tested positive for COVID-19 within 7 days prior to Day 1.
  9. Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV).
  10. Other primary malignancies, except:

    1. Adequately treated basal cell or squamous cell carcinoma
    2. In situ carcinoma of the cervix or bladder, treated curatively and without evidence of recurrence for at least 2 years prior to the study, or
    3. A primary malignancy which has been completely resected and in complete remission for at least 2 years
  11. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  12. Prior grade > 3 immune-related AEs such as pneumonitis, colitis, hepatitis, nephritis; prior dermatitis and endocrinopathies are allowed provided corticosteroids are no longer required and endocrine-replacement therapy is stable and discontinued from prior therapy.
  13. Active autoimmune disease not related to prior therapy for primary malignancy that has required systemic therapy in the last 1 year.
  14. History of symptomatic congestive heart failure (New York Heart Association classes II-IV) or serious active arrhythmias or other clinically significant cardiac disease within 12 months of enrollment.
  15. Toxicity from previous anti-cancer therapy defined as toxicities (other than alopecia, or laboratory values listed above) not yet resolved to NCI CTCAE v5.0 Grade ≤ 1 or baseline. Participants with chronic Grade 2 toxicities (eg, peripheral neuropathy, laboratory values) may be eligible per the discretion of the Investigator and Medical Monitor.
  16. Has received:

    1. Radiotherapy within 2 weeks of first administration of MT-302
    2. Cytotoxic chemotherapy for treatment of the primary malignancy within 28 days or 5 half-lives, whichever is shorter, of administration of MT-302
    3. Immune therapy for primary malignancy (eg, monoclonal antibody therapy, checkpoint inhibitors) within 28 days or 5 half-lives, whichever is shorter of first administration of MT-302
    4. Targeted therapies for primary malignancy within 28 days or 5 half-lives, whichever is shorter, of first administration of MT-302
    5. Anti-cancer vaccine within 12 weeks of first administration of MT-302
    6. COVID-19 mRNA vaccine within 6 weeks of first administration of MT-302
  17. Has received a live vaccine ≤ 6 weeks prior to first administration of MT-302
  18. Has received packed red blood cells or platelet transfusion within 2 weeks prior to first administration of MT-302
  19. History of an allergic reaction to any of the excipients
  20. Enrollment in another interventional clinical trial within 28 days or 5 half-lives of the drug, whichever is shorter, of first administration of MT-302
  21. Any other condition that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the study requirements.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shinam Garg +61 2 9171 3260 Shinam.garg@novotech-cro.com
Contact: Clinical Operations +1 617 465 1022 mt-302clinical@myeloidtx.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05969041
Other Study ID Numbers  ICMJE MTX-TROP2-302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Myeloid Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Myeloid Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Matthew Maurer, MD Myeloid Therapeutics
PRS Account Myeloid Therapeutics
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP