Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT07076550

Recruiting

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

Interventional

Phase 1

Fiona Stanley Hospital

Sponsor: Alpha-9 Oncology

Last Updated: March 16, 2026

Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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

Show Detailed Description

Treatment Category

Radiopharmaceuticals, Diagnostic Test

Required Mutations

None

Trial Started

November 19, 2025

Last Updated by Sponsor

March 16, 2026

Estimated Completion

January 1, 2028

Contact Study

Name:Sam Vohra

Email:sam@avionmedical.com.au

Phone:+61 300 131 548

Eligibility

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

Do you think this trial is incorrectly appearing?

Design Details

AllocationNon-Randomized

Intervention ModelSequential Assignment

MaskingNone (Open Label)

Number to Enroll50

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: 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.

Interventions:

[225Ac]Ac-A9-3408
[68Ga]Ga-A9T-3202

Outcome Measures

Primary Outcome Measures

Determine max tolerated dose and recommended Phase 2 DoseFirst 28 days following first study treatment

Rate of DLTs per dose level/cohort

Incidence of treatment-related adverse eventsFrom first study treatment until end of treatment

Rate and severity of suspected treatment-related adverse events, change from baseline laboratory values and change from baseline vital signs as graded by CTCAE version 5.0

Secondary Outcome Measures

Evaluate the preliminary efficacy of [225Ac]Ac-A9-3408 by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)Up to 1 year from enrollment

Percent of patients who achieve an overall response (ORR), defined as the percent of patients who achieve a complete response (CR) or partial response (PR) by RECIST v1.1

Evaluate biodistribution and normal organ dosimetry of [225Ac]Ac-A9-3408Up to 7 days following each cycle (42 days)

Absorbed radiation dose estimates (Gy) in normal organs for [225Ac]Ac-A9-3408

Bookmark trial

Share Trial

Download Trial

Do you think this trial is incorrectly appearing?

Report Trial

Download Trial

Trial Sites

This study has 4 trial sites

Fiona Stanley Hospital

Murdoch, Western Australia, AU

Name:Dr. Zeyad Al-Ogaili

Email:zeyad.al-ogaili@health.wa.gov.au

Phone:+61426824336

Not yet recruiting

Murdoch, Western Australia, 6150 AU

Fiona Stanley Hospital

Recruiting

Melbourne, Victoria, 3084 AU

Austin Health

Recruiting

Melbourne, Victoria, 3004 AU

Alfred Health

Not yet recruiting

Murdoch, Western Australia, 6150 AU

GenesisCare Murdoch

Loading Maps...