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

NCT07076550 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-16

No results posted yet for this study

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

Conditions

  • Melanoma Metastatic
  • Uveal Melanoma, Metastatic
  • Mucosal Melanoma

Interventions

DRUG

[225Ac]Ac-A9-3408

Administered IV

DIAGNOSTIC_TEST

[68Ga]Ga-A9T-3202

Administered IV

Sponsors & Collaborators

  • Alpha-9 Oncology USA Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-19
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07076550 on ClinicalTrials.gov