Actively Recruiting
Phase 1 Study of MT-302 Drug in Adults With Advanced or Metastatic Epithelial Cancers
Led by Myeloid Therapeutics · Updated on 2024-01-18
48
Participants Needed
6
Research Sites
52 weeks
Total Duration
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
Research Team
S
Shinam Garg
C
Clinical Operations
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