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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
MT-302 is an investigational drug
St Vincent's Public Hospital Sydney
Darlinghurst, New South Wales, Australia
RECRUITINGScientia Clinical Research Ltd
Randwick, New South Wales, Australia
RECRUITINGWestmead Hospital
Westmead, New South Wales, Australia
To evaluate the safety and tolerability of MT-302 through incidence of Adverse Events
Adverse Events will be graded according to the NCI-CTCAE, version 5.0
Time frame: Up to Week 20
To establish the maximum tolerated dose (MTD)
based on dose limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D)
Time frame: Up to Week 20
To further characterize the safety of MT-302 through incidence of Adverse Events
Adverse Events will be graded according to the NCI-CTCAE, version 5.0
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter: Plasma concentrations
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter: Area under curve (AUC0-last, AUC 0-∞)
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter: Time of maximum observed plasma concentration (tmax)
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter: Apparent terminal Half-life (t1/2)
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter: Plasma Clearance (CL)
Time frame: Up to Week 20
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Souther Oncology Clinical Research Unit (SOCRU)
Bedford Park, South Australia, Australia
RECRUITINGCabrini Health
Malvern, Victoria, Australia
RECRUITINGLinear Clinical Research Ltd
Nedlands, Western Australia, Australia
RECRUITINGTo assess the pharmacokinetics (PK) of MT-302
PK parameter: Volume of Distribution (Vd)
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter:Mean residence time (MRT)
Time frame: Up to Week 20
To assess the pharmacokinetics (PK) of MT-302
PK parameter: terminal rate constant ( λz)
Time frame: Up to Week 20
Determine rate of ICANS
For grading of potential immune effector cell-associated neurotoxicity syndrome (ICANS), use of the 10-point immune effector cell-associated encephalopathy (ICE) screening tool
Time frame: Up to Week 20
Determine rate of Grade 3-5 CRS
ASCO CRS Grading
Time frame: Up to Week 20