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Radioactive drug targets Hard-to-Treat melanoma in early trial

NCT ID NCT07076550

Disease control Sponsor: Alpha-9 Oncology USA Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This early-stage trial tests a radioactive drug called [225Ac]Ac-A9-3408 in 50 adults with melanoma that has spread or can't be removed by surgery. The main goals are to find a safe dose and check for side effects. Participants receive the drug every 6 weeks for up to 6 doses, and doctors will also see if tumors shrink.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A radioactive drug called [225Ac]Ac-A9-3408 given by IV
What this could lead to
If it works, this could point toward a new treatment option for advanced melanoma that has spread or cannot be removed by surgery.
What could go wrong
This is an early Phase 1 trial with only 50 people, so safety and effectiveness are not yet known. The drug is radioactive and may cause side effects; it is not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

5 people

The number who actually took part.

Started

Nov 2025

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 * Adequate baseline organ function within 14 days of first dose of investigational product * Recovered from side effects of prior anticancer therapy * 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 Exclusion Criteria: * Previous treatment with radioactive nuclides except radioactive imaging tracers * Treatment with another investigational product shortly prior to first dose of \[225Ac\]Ac-A9-3408 with exception of anti-PD-1/PD-L1 agents. * Concurrent anticancer therapy * Major surgery within 4 weeks of first dose of investigational product * Second malignancy within 2 years * Active, clinically serious infection * Known infusion reactions to components of the investigational product * Other clinically serious health conditions including cardiovascular and or severe infectious diseases * Significant central nervous system metastatic disease * Pregnant, breastfeeding or unwilling to practice adequate birth control method(s) * Any condition per the opinion of the investigator that would impact the safety of the subject, protocol adherence or ability to provide informed consent

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma metastatic melanoma mucosal melanoma Neoplasm Metastasis uveal melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma metastatic Mucosal melanoma Uveal melanoma, metastatic

Contacts and locations

Locations

  • Alfred Health

    Melbourne, Victoria, 3004, Australia

  • Austin Health

    Melbourne, Victoria, 3084, Australia

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • GenesisCare Murdoch

    Murdoch, Western Australia, 6150, Australia

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