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

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

Trial Details

NCT ID
NCT07076550
Phase
PHASE1
Sponsor
Alpha-9 Oncology USA Inc.
Status
RECRUITING
Cancer Type
Mucosal Melanoma Melanoma
Interventions
  • [225Ac]Ac-A9-3408
  • [68Ga]Ga-A9T-3202
Locations (sample)
  • Melbourne, Victoria, Australia|-37.814,144.96332
  • Melbourne, Victoria, Australia|-37.814,144.96332
  • Murdoch, Western Australia, Australia|-32.06987,115.83757
  • Murdoch, Western Australia, Australia|-32.06987,115.83757

Key Eligibility Criteria

  • Able to provide written informed consent
  • \[68Ga\]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
  • Adequate ECOG performance status

For full eligibility, visit ClinicalTrials.gov.

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