Tests MT-302 in adults with advanced epithelial tumors

Trial details

Who runs it

Myeloid Therapeutics

Trial code

NCT05969041

Record updated

18 January 2024

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: Adults age ≥ 18 inclusive at the time the Informed Consent 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 adenocarcinoma; Gastric adenocarcinoma; Esophageal carcinoma; Non-small cell lung; Colorectal; 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 Oncology Group (ECOG) performance status grade of 0 or 1; Life expectancy of > 12 weeks; Echocardiogram (ECHO) or multiple gated acquisition scan showing an ejection fraction greater than or equal to 50%; 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; 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 dose of study treatment; Men and WOCBP must be willing to practice a highly effective method of contraception.

Exclusion: 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; Must be > 28 days beyond major surgery, including hepatectomy or joint replacement; Prior allogeneic bone marrow transplantation or solid organ transplant; Spinal cord compression not definitively treated with surgery and/or radiation; Any acute illness including fever (> 100.4° F or > 38° C) within 7 days prior to Day 1; 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; Other primary malignancies, except:; Adequately treated basal cell or squamous cell carcinoma; 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; A primary malignancy which has been completely resected and in complete remission for at least 2 years; 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; Active autoimmune disease not related to prior therapy for primary malignancy that has required systemic therapy in the last 1 year; Has received:; Radiotherapy within 2 weeks of first administration of MT-302; Cytotoxic chemotherapy for treatment of the primary malignancy within 28 days or 5 half-lives, whichever is shorter, of administration of MT-302; 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; Targeted therapies for primary malignancy within 28 days or 5 half-lives, whichever is shorter, of first administration of MT-302; Anti-cancer vaccine within 12 weeks of first administration of MT-302; COVID-19 mRNA vaccine within 6 weeks of first administration of MT-302; Has received a live vaccine ≤ 6 weeks prior to first administration of MT-302; 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; Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV); History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease; 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; History of an allergic reaction to any of the excipients; 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; 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; Has received packed red blood cells or platelet transfusion within 2 weeks prior to first administration of MT-302; Pregnant or nursing women; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.

ClinicalTrials.gov NCT05969041