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Study 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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-08-02
Primary completion: 2027-08-31
Study completion finish: 2028-08-31
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05969041
Intervention or treatment
DRUG: MT-302 (A)
Conditions
- • Epithelial Tumors, Malignant
Find a site
Closest Location:
Scientia Clinical Research Ltd
Research sites nearby
Select from list below to view details:
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
St Vincent's Public Hospital Sydney
Darlinghurst, New South Wales, Australia
Souther Oncology Clinical Research Unit (SOCRU)
Bedford Park, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: A (MT-302)
| DRUG: MT-302 (A)
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 | Up to Week 20 |
To establish the maximum tolerated dose (MTD) | based on dose limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D) | Up to Week 20 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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 | Up to Week 20 |
To assess the pharmacokinetics (PK) of MT-302 | PK parameter: Plasma concentrations | Up to Week 20 |
To assess the pharmacokinetics (PK) of MT-302 | PK parameter: Area under curve (AUC0-last, AUC 0-∞) | Up to Week 20 |
To assess the pharmacokinetics (PK) of MT-302 | PK parameter: Time of maximum observed plasma concentration (tmax) | Up to Week 20 |
To assess the pharmacokinetics (PK) of MT-302 | PK parameter: Apparent terminal Half-life (t1/2) | Up to Week 20 |
To assess the pharmacokinetics (PK) of MT-302 | PK parameter: Plasma Clearance (CL) | Up to Week 20 |
To assess the pharmacokinetics (PK) of MT-302 | PK parameter: Volume of Distribution (Vd) | Up to Week 20 |
To assess the pharmacokinetics (PK) of MT-302 | PK parameter:Mean residence time (MRT) | Up to Week 20 |
To assess the pharmacokinetics (PK) of MT-302 | PK parameter: terminal rate constant ( λz) | 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 | Up to Week 20 |
Determine rate of Grade 3-5 CRS | ASCO CRS Grading | Up to Week 20 |
Frequently Asked Questions
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