Recruiting

[225Ac]Ac-A9-3408 for Unresectable or Metastatic Melanoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

[225Ac]Ac-A9-3408

+ [68Ga]Ga-A9T-3202

DrugDiagnostic Test
Who is being recruted

Uveal Melanoma+18

+ Eye Diseases

+ Eye Neoplasms

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorAlpha-9 Oncology USA Inc.
Study ContactSam Vohra
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 19, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on evaluating a new treatment, called [225Ac]Ac-A9-3408, for people with melanoma that cannot be surgically removed or has spread to other parts of the body (metastatic melanoma). The study aims to assess how safe and tolerable this treatment is, as well as how effectively it targets and impacts both normal organs and tumors. This is especially important for those whose melanoma has worsened despite receiving therapies that target the PD-1/PD-L1 pathway, which are common treatments for this type of cancer. Participants in the study will undergo a screening process where a diagnostic substance, [68Ga]Ga-A9T-3202, is given through an IV to help assess the condition. Then, the treatment [225Ac]Ac-A9-3408 is administered through an IV every six weeks, with up to six treatment cycles in total. Throughout the study, researchers will closely monitor participants to determine the treatment's safety and its effects on both the cancer and normal body tissues. This study does not list specific risks or benefits, but as with any experimental treatment, monitoring is essential to understand its potential impacts.

Official TitleA Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of [225Ac]Ac-A9-3408 in Subjects With Unresectable or Metastatic Melanoma
NCT07076550
Principal SponsorAlpha-9 Oncology USA Inc.
Study ContactSam Vohra
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Uveal MelanomaEye DiseasesEye NeoplasmsMelanomaNeoplasm MetastasisNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeoplastic ProcessesPathologic ProcessesSkin DiseasesSkin NeoplasmsPathological Conditions, Signs and SymptomsUveal DiseasesUveal NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

Criteria

7 inclusion criteria required to participate
Adequate ECOG performance status
Women of childbearing potential (WOCBP) must have a negative pregnancy test and follow adequate birth control method(s) during the treatment period and for at least 6 months after last dose of [225Ac]Ac-A9-3408. Sexually active males with partners who are WOCBP must agree to adequate birth control method(s) during the treatment period and for at least 3 months after last dose of [225Ac]Ac-A9-3408
Able to provide written informed consent
68Ga]Ga-A9T-3202 uptake in at least one measurable lesion (per RECIST v1.1) on PET scan
Show More Criteria
11 exclusion criteria prevent from participating
Concurrent anticancer therapy
Treatment with another investigational product shortly prior to first dose of [225Ac]Ac-A9-3408 with exception of anti-PD-1/PD-L1 agents
Known infusion reactions to components of the investigational product
Major surgery within 4 weeks of first dose of investigational product
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants enrolled in Dose Escalation will receive a single dose of the investigational diagnostic agent \[68Ga\]Ga-A9T-3202 during screening, and receive the investigational treatment \[225Ac\]Ac-A9-3408 once every 6 weeks, for up to 6 total cycles.

Group II

Experimental
Participants enrolled in Dose Expansion will receive a single dose of the investigational diagnostic agent \[68Ga\]Ga-A9T-3202 during screening, and receive the investigational treatment \[225Ac\]Ac-A9-3408 once every 6 weeks, for up to 6 total cycles.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

Alfred Health

Melbourne, AustraliaOpen Alfred Health in Google Maps
Recruiting

Austin Health

Melbourne, Australia
Recruiting soon

Fiona Stanley Hospital

Murdoch, Australia
Recruiting soon

GenesisCare Murdoch

Murdoch, Australia
Recruiting
4 Study Centers