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RECRUITING
NCT07076550
PHASE1

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

Sponsor: Alpha-9 Oncology USA Inc.

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-11-19

Completion Date

2028-01

Last Updated

2026-03-16

Healthy Volunteers

No

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