RecruitingPhase 1NCT07076550

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

A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of [225Ac]Ac-A9-3408 in Subjects With Unresectable or Metastatic Melanoma


Sponsor

Alpha-9 Oncology USA Inc.

Enrollment

50 participants

Start Date

Nov 19, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study is testing the safety, dosing, and early effectiveness of a new radioactive therapy called A9-3408 in people with advanced or metastatic melanoma (skin cancer that has spread) whose cancer has progressed after standard treatments. **You may be eligible if...** - You have been diagnosed with unresectable or metastatic melanoma confirmed by biopsy - Your cancer progressed after prior standard-of-care therapy - A specific PET scan shows uptake of a companion imaging agent in at least one measurable tumor - Your overall health and organ function are adequate - If you can become pregnant or are sexually active with someone who can become pregnant, you must use appropriate birth control **You may NOT be eligible if...** - You have not recovered from side effects of prior treatments - Your organ function does not meet the study's baseline requirements - You are pregnant 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[225Ac]Ac-A9-3408

Administered IV

DIAGNOSTIC_TEST[68Ga]Ga-A9T-3202

Administered IV


Locations(4)

Alfred Health

Melbourne, Victoria, Australia

Austin Health

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

GenesisCare Murdoch

Murdoch, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT07076550


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