Actively Recruiting
MYE Symphony: Phase 1 Open-Label Study of MT-302 for Adults With Advanced or Metastatic Epithelial Tumors
Led by Myeloid Therapeutics · Updated on 2024-01-18
48
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MT-302 in adults with advanced or metastatic epithelial tumors in a Phase 1, first-in-human study called MYE Symphony. This trial aims to assess the safety, tolerability, and appropriate dose of MT-302 for this group of participants. The study is led by Myeloid Therapeutics and includes patients with various types of epithelial cancers who have progressive disease despite standard treatments or have chosen not to undergo standard therapy. Participants are grouped into four cohorts, each receiving MT-302 through intravenous infusion in cycles. For Cohorts 1 to 3, dosing occurs every 14 days for three doses, then every 28 days for three more doses. Cohort 4 has a modified regimen with weekly doses for three weeks, followed by doses every 28 days for three additional weeks. The study includes oversight by a Safety Review Committee to monitor clinical safety throughout the trial. During the study, participants will be closely monitored for side effects and overall safety up to week 20. Researchers will assess drug levels in the body, safety events, and determine the highest dose tolerated. Patients will undergo various tests including heart function scans, laboratory assessments, and disease evaluations using standardized imaging criteria. The study lasts through multiple treatment cycles with ongoing safety and pharmacokinetic evaluations to guide dosing and participant care.
CONDITIONS
Brief Title
Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 18 or older at the time of informed consent
- Histologically confirmed metastatic or advanced epithelial cancer of specified types including urothelial, cervical, ovarian epithelial, triple-negative breast, HR+/HER2- breast, pancreatic ductal adenocarcinoma, gastric adenocarcinoma, esophageal carcinoma, non-small cell lung, or colorectal
- Progressive disease at baseline, refractory or relapsed to standard of care or declined standard therapy
- Measurable disease by RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy greater than 12 weeks
- Ejection fraction of 50% or higher on echocardiogram or MUGA scan
- ECG with no clinically significant abnormalities and QTc intervals within specified limits
- Oxygen saturation of 90% or higher on room air
- Adequate organ function based on laboratory tests
- Able and willing to provide written informed consent
- Willing to comply with all study procedures including biopsies and visits
- Men must abstain from sperm donation during treatment and for 4 months after last dose
- Men and women of childbearing potential must agree to use highly effective contraception
You will not qualify if you...
- Active central nervous system metastasis or carcinomatous meningitis unless stable and without steroids for at least 14 days
- Pregnant or nursing women
- Less than 28 days since major surgery including hepatectomy or joint replacement
- Prior allogeneic bone marrow or solid organ transplant
- Untreated spinal cord compression
- Uncontrolled effusions requiring frequent drainage
- Acute illness or fever within 7 days before first dose
- Active systemic infections or positive COVID-19 test within 7 days before first dose
- Active HIV, hepatitis B or C infection
- Other primary malignancies except certain treated basal or squamous cell carcinomas and in situ carcinomas without recurrence for 2 years
- History or current pneumonitis or interstitial lung disease requiring steroids
- Prior severe immune-related adverse events except certain conditions
- Active autoimmune disease requiring systemic therapy in the past year
- Significant cardiac disease or arrhythmias within 12 months
- Unresolved toxicities from previous cancer treatments above specified grades
- Recent radiotherapy, chemotherapy, immune therapy, targeted therapy, anti-cancer vaccine, or COVID-19 mRNA vaccine within specified timeframes before first dose
- Recent live vaccine or blood transfusions within specified periods
- History of allergic reactions to excipients
- Enrollment in another interventional clinical trial within specified timeframes
- Any other condition making participation unsuitable or compliance unlikely as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to approximately 20 weeks
Participants receive the investigational drug MT-302 through intravenous infusion following their cohort-specific dosing regimen.
Multiple infusions with dosing every 7 to 28 days depending on cohort, over 4 cycles
Trial Site Locations
Total: 6 locations
1
St Vincent's Public Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
2
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia, 2031
Actively Recruiting
3
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
4
Souther Oncology Clinical Research Unit (SOCRU)
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
5
Cabrini Health
Malvern, Victoria, Australia, 3144
Actively Recruiting
6
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
S
Shinam Garg
C
Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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