Clinical Trial · NCT07076550

A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma

Overview

The goal of this trial is to see if this investigational drug is safe for adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery. It will also see if this investigational drug can shrink melanoma tumors in the body. The main questions this study aims to answer are: * What are the side effects of this investigational drug? * What is the highest dose of this investigational drug that can be given safely? Participants will: * Take the investigational drug once every 6 weeks, for up to 6 times in total * Visit a doctor's office on a regular basis for checkups and tests

Sponsor

Unknown Organization

Phase

Phase 1

ClinicalTrials.gov

NCT07076550

Drug / Compound

A9-3408

Isotope(s):

Target(s):

MC1R

Ligand Class: Small Molecules

A9T-3202

Isotope(s):

Target(s):

MC1R

Ligand Class: Small Molecules

Eligibility

Inclusion

\[68Ga\]Ga-A9T-3202 uptake in at least one measurable lesion (per RECIST v1.1) on PET scan
Histologically or cytologically confirmed unresectable or metastatic melanoma with disease progression on prior standard of care therapy

Exclusion

Treatment with another investigational product shortly prior to first dose of \[225Ac\]Ac-A9-3408 with exception of anti-PD-1/PD-L1 agents.
Concurrent anticancer therapy
Previous treatment with radioactive nuclides except radioactive imaging tracers
Significant central nervous system metastatic disease