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

NCT 05969041

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.

Intervention / Treatment 

  • Drug: MT-302 (A)

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.

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