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 advancedat a late stage, far along epithelial cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs.
Intervention / Treatment
- Drug: MT-302 (A)
Inclusion Criteria:
- Adults age ≥ 18 inclusive at the time the Informed Consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. Form (ICF) is signed.
- Histologically proven, metastatic or advanced epithelial cancer including the following cancer types:
- Urothelial
- Cervical
- Ovarian epithelial
- Triple-negative breast
- HR+/HER2- breast
- Pancreatic ductal adenocarcinomacancer arising from mucus-producing glands in organs
- Gastric adenocarcinoma
- Esophageal carcinomacancer arising from tissues that line organs
- Non-small cell lung
- Colorectalrelating to the colon or rectum in the large bowel/intestine
- Progressive disease at baseline, refractory or relapsed to standard of care or who have declined standard therapy.
- Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria v 1.1.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells of 0 or 1.
- Life expectancy of > 12 weeks.
- Echocardiograma type of ultrasound that uses sound waves to create detailed images of the heart to assess heart structure, function and blood flow (ECHO) or multiple gated acquisition scan showing an ejection fraction greater than or equal to 50%.
- Electrocardiogram (ECG) showing no clinically significant abnormality at Screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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.
- Oxygen saturation of greater than or equal to 90% on room air measured by pulse oximetry.
- Adequate organ function as defined by laboratory values at Screening.
- Willing and able to provide written informed consent.
- Willing to perform and comply with all study procedures including undergoing study-related biopsies and attending clinic visits as scheduled.
- Men must abstain from sperm donation during study treatment or for 4 months following last dosethe amount of medication taken of study treatment.
- Men and WOCBP must be willing to practice a highly effective method of contraception.