Actively Recruiting
A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of [225Ac]Ac-A9-3408 in Subjects With Unresectable or Metastatic Melanoma
Led by Alpha-9 Oncology USA Inc. · Updated on 2026-03-16
50
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an investigational drug called [225Ac]Ac-A9-3408 in adults with melanoma that cannot be removed by surgery or has spread to other parts of the body. The study aims to find out the side effects of this drug and identify the highest safe dose. It also examines how well the drug shrinks melanoma tumors and measures how much of the drug reaches normal organs and tumors. Participants receive an intravenous injection of the investigational drug once every 6 weeks, for up to 6 doses. Before treatment, they are given a single intravenous dose of the diagnostic agent [68Ga]Ga-A9T-3202 during screening. The study includes two groups: a dose escalation phase to find the recommended dose and a dose expansion phase to further evaluate safety and effectiveness at that dose. During the trial, participants visit the doctor's office regularly for checkups, scans, and tests, including PET scans to measure drug uptake and tumor response. Researchers monitor side effects from the first treatment until the end of the study and assess tumor responses up to one year after enrollment. The study also tracks how the drug distributes in the body and its effects on organs. Total participation may last several months depending on the treatment cycles received.
CONDITIONS
Brief Title
A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent
- Uptake of [68Ga]Ga-A9T-3202 in at least one measurable lesion on PET scan
- Histologically or cytologically confirmed unresectable or metastatic melanoma with disease progression on prior standard therapy
- Adequate ECOG performance status
- Adequate baseline organ function within 14 days before first dose
- Recovered from side effects of prior anticancer therapy
- Women of childbearing potential must have a negative pregnancy test and use birth control during treatment and for 6 months after last dose
- Sexually active males with partners who are women of childbearing potential must use birth control during treatment and for 3 months after last dose
You will not qualify if you...
- Previous treatment with radioactive nuclides except imaging tracers
- Recent treatment with another investigational product except anti-PD-1/PD-L1 agents
- Concurrent anticancer therapy
- Major surgery within 4 weeks before first dose
- Second cancer within 2 years
- Active serious infection
- Known infusion reactions to investigational product components
- Serious health conditions including cardiovascular or severe infections
- Significant central nervous system metastatic disease
- Pregnant, breastfeeding, or unwilling to use birth control
- Any condition that impacts safety, protocol adherence, or ability to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including administration of a diagnostic agent
Duration - Up to approximately 36 weeks
Participants receive the investigational drug [225Ac]Ac-A9-3408 administered intravenously once every 6 weeks for up to 6 cycles.
Up to 6 visits every 6 weeks (in-person)
Trial Site Locations
Total: 4 locations
1
Alfred Health
Melbourne, Victoria, Australia, 3004
Actively Recruiting
2
Austin Health
Melbourne, Victoria, Australia, 3084
Actively Recruiting
3
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Not Yet Recruiting
4
GenesisCare Murdoch
Murdoch, Western Australia, Australia, 6150
Not Yet Recruiting
Research Team
S
Sam Vohra
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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