Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05496686
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2022-08-09
Brief Title:
Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma
Sponsor:
Modulation Therapeutics Inc
Organization:
Modulation Therapeutics Inc
Study Overview
Official Title:
First in Human Phase I Study of 225Actinium-MTI-201 225Ac-MTI-201 in Metastatic Uveal Melanoma
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary aim of the study is to establish the maximum-tolerated dose MTD of 225Ac-MTI-201 in participants with metastatic uveal melanoma The secondary aims are to describe the pharmacokinetics of 225Ac-MTI-201 and the toxic effects of 225Ac-MTI-201 in participants with metastatic uveal melanoma
Detailed Description:
This study will enroll patients with metastatic uveal melanoma that have failed at least one form of therapy from a single academic medical center in the United States All participants will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures A continual reassessment method CRM design will be used for this clinical trial The study proposes single patient cohorts with dose escalation starting at 47 microCi of 225Ac-MTI-201 after each cohort in the absence of safety concerns 2-fold increases for doses and lower dose increases between higher doses Dose Limiting Toxicities will be assessed using the CTCAE version 50 criteria
The participants who meet the eligibility requirements will be administered a single intravenous dose of 225Ac-MTI-201 After study treatment the study participants will stay overnight at the study center undergo study procedures ie vital signs physical exam multiple blood and urine sample collections and will be scheduled to return to the clinic at 48 hours and for additional appointments weekly clinic visits the first month and on Week 9 for health status assessments including physical exams complete blood chemistry and EKG Tumor measurements every 8 weeks in first year post-injection extended to 12 weeks in year 2 every 16 weeks in year 3 and 24 weeks in years 4 and 5 The clinic visits will involve seeing a study doctor plus radiological tests such as MRI andor CT scans to see how the metastatic uveal melanoma has responded to the study drug The protocol and informed consent documents have been reviewed and approved by the hospital human subjects review board and the study will be performed in accordance with the Declaration of Helsinki
The participants who meet the eligibility requirements will be administered a single intravenous dose of 225Ac-MTI-201 After study treatment the study participants will stay overnight at the study center undergo study procedures ie vital signs physical exam multiple blood and urine sample collections and will be scheduled to return to the clinic at 48 hours and for additional appointments weekly clinic visits the first month and on Week 9 for health status assessments including physical exams complete blood chemistry and EKG Tumor measurements every 8 weeks in first year post-injection extended to 12 weeks in year 2 every 16 weeks in year 3 and 24 weeks in years 4 and 5 The clinic visits will involve seeing a study doctor plus radiological tests such as MRI andor CT scans to see how the metastatic uveal melanoma has responded to the study drug The protocol and informed consent documents have been reviewed and approved by the hospital human subjects review board and the study will be performed in accordance with the Declaration of Helsinki
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MTI201-IA | OTHER | Modulation Therapeutics Inc | None |