NCT05969041

Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Myeloid Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study has 4 Cohorts. Each Cohort has 4 Cycles. For Cohorts 1-3, the dosing regimen will be every 14 days for 3 doses, followed by administration once every 28 days for three doses. For Cohort 4, the dosing regimen will be modified. Participants will receive one dose of MT-302 every week for 3 doses, followed by administration once every 28 days for three additional doses. A Safety Review Committee (SRC) will provide oversight for this study. The primary responsibility of the SRC is to safeguard study participants by reviewing and assessing the clinical safety data being collected during the conduct of the study.

Conditions

• Epithelial Tumors, Malignant

Interventions

Type	Name	Description
DRUG	MT-302 (A)	MT-302 is an investigational drug

Timeline

• Start date: 2023-08-02
• Primary completion: 2027-08-31
• Completion: 2028-08-31
• First posted: 2023-08-01
• Last updated: 2024-01-18

Locations

6 sites across 1 country: Australia