Actively Recruiting
A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma
Led by Alpha-9 Oncology USA Inc. · Updated on 2026-03-16
50
Participants Needed
4
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- At least one measurable lesion showing uptake of [68Ga]Ga-A9T-3202 on PET scan
- Histologically or cytologically confirmed unresectable or metastatic melanoma with disease progression after prior standard therapy
- Adequate ECOG performance status
- Adequate baseline organ function within 14 days before first treatment dose
- Recovered from side effects of prior anticancer treatments
- Women of childbearing potential must have a negative pregnancy test and agree to use birth control during treatment and for 6 months after last dose
- Sexually active males with partners who are women of childbearing potential must agree to use birth control during treatment and for 3 months after last dose
You will not qualify if you...
- Prior treatment with radioactive nuclides except imaging tracers
- Recent treatment with another investigational drug except anti-PD-1/PD-L1 agents
- Receiving other anticancer therapy concurrently
- Major surgery within 4 weeks before first treatment dose
- Diagnosis of a second cancer within the past 2 years
- Active serious infections
- Known infusion reactions to study drug components
- Other serious health conditions including cardiovascular or severe infections
- Significant metastatic disease in the central nervous system
- Pregnant, breastfeeding, or unwilling to use birth control
- Any condition that may affect safety, study compliance, or informed consent per investigator's judgment
AI-Screening
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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
CONTACT
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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