Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 4.7 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 5.0 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 (i.e. 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 and/or 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05496686
Study type	Interventional
Source	Modulation Therapeutics, Inc.
Contact	Mark L McLaughlin, PhD
Phone	813-784-0033
Email	mlm@modulationtherapeutics.com
Status	Recruiting
Phase	Phase 1
Start date	July 21, 2022
Completion date	February 25, 2029

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04364230` - Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma)	Phase 1/Phase 2
Completed	`NCT03652077` - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies	Phase 1
Active, not recruiting	`NCT05542342` - Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases.	Phase 2
Completed	`NCT02849145` - Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)	N/A
Recruiting	`NCT01438658` - Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma	N/A
Not yet recruiting	`NCT00811200` - Treatment Of Radiation Retinopathy Trial	Phase 2/Phase 3
Completed	`NCT00121225` - Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma	Phase 2
Recruiting	`NCT05077280` - A Study of Concurrent Stereotactic Body Radiotherapy With Opdualag in Metastatic Uveal Melanoma	Phase 2
Completed	`NCT03297424` - A Study of PLX2853 in Advanced Malignancies.	Phase 1
Withdrawn	`NCT05482074` - Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2	Phase 2
Completed	`NCT04551352` - A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas	Phase 1
Not yet recruiting	`NCT06246149` - Adjuvant Tebentafusp in High Risk Ocular Melanoma	Phase 3
Completed	`NCT01955941` - Vascular Response to Brachytherapy Using Functional OCT
Completed	`NCT00661622` - Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF	Phase 2
Recruiting	`NCT05502900` - Adjuvant Melatonin for Uveal Melanoma	Phase 3
Active, not recruiting	`NCT03070392` - Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma	Phase 2
Recruiting	`NCT06284512` - Uveal Melanoma - Comparative Study
Recruiting	`NCT05524935` - Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma	Phase 2
Active, not recruiting	`NCT02913417` - Yttrium90, Ipilimumab, & Nivolumab for Uveal Melanoma With Liver Metastases	Phase 1/Phase 2
Not yet recruiting	`NCT06073548` - Patient Experience and Quality of Life During the Surveillance Phase of Uveal Melanoma: A Prospective Multi-method Study

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.