RecruitingPhase 1Phase 2NCT05655312

MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma

A Phase I/IIa, First-In-Human, Multi-Center, Monotherapy and Combination-Therapy With Nivolumab, Dose-Finding and Dose-Expansion Study of [212Pb]VMT01 Melanocortin-1 Receptor-Targeted, Image-Guided Alpha-Particle Therapy in Subjects With Previously Treated Unresectable or Metastatic Melanoma


Sponsor

Perspective Therapeutics

Enrollment

300 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

In this first-in human, phase I/IIa study, the safety and efficacy of \[212Pb\]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated as a monotherapy and in combination with nivolumab in subjects with unresectable and metastatic melanoma.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of targeted radiation therapy (called alpha-particle therapy) that specifically seeks out melanoma cells using a protein called MC1R found on their surface. It is being tested alone and in combination with nivolumab (an immunotherapy drug) in adults with advanced melanoma. **You may be eligible if...** - You are 18 or older - You have advanced melanoma (unresectable Stage III or Stage IV) that has come back or progressed after at least one approved treatment - Your melanoma tumors show uptake of the targeting agent on imaging scans - Your overall health and organ function meet study requirements **You may NOT be eligible if...** - You have not previously received treatment for advanced melanoma - Your tumors do not show uptake of the imaging agent used in this study - You have serious medical conditions that would make participation unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[203Pb]VMT01

\[203Pb\]VMT01 is administered intravenous (IV) as an imaging agent for SPECT/CT

DRUG[212Pb]VMT01

Subjects with positive uptake of \[203Pb\]VMT01 will receive a fixed dose of \[212Pb\]VMT01 administered IV every 8 weeks starting at Cycle 1 Day 1.

DRUGNivolumab

For all combination-therapy cohorts, 480 mg nivolumab will be administered every 4 weeks as an IV infusion.


Locations(13)

University of California Irvine

Orange, California, United States

Mayo Clinic

Jacksonville, Florida, United States

University of Miami

Miami, Florida, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

University of Iowa

Iowa City, Iowa, United States

University of Kentucky

Lexington, Kentucky, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Saint Louis University Hospital

St Louis, Missouri, United States

Washington University of St. Louis

St Louis, Missouri, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05655312


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