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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
Sponsor: Alpha-9 Oncology USA Inc.
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
[225Ac]Ac-A9-3408
Administered IV
[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