NCT07076550

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

A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of [225Ac]Ac-A9-3408 in Subjects With Unresectable or Metastatic Melanoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Alpha-9 Oncology USA Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a multicenter, open-label Phase 1-1b study of \[225Ac\]Ac-A9-3408 in subjects with unresectable or metastatic melanoma. The primary aim of the Phase 1 portion of the study is to evaluate the safety and tolerability as well as the normal organ and tumor dosimetry of \[225Ac\]Ac-A9-3408 and to select a recommended Phase 2 dose (RP2D). The aim of Phase 1b will be to evaluate the safety, efficacy, and normal organ and tumor dosimetry of \[225Ac\]Ac-A9-3408 administered at the RP2D in subjects with unresectable or metastatic cutaneous melanoma who had confirmed disease progression while receiving an anti-PD-1/PD-L1-containing regimen. The interventional diagnostic \[68Ga\]Ga-A9T-3202 will be administered intravenously (IV) once during screening. The interventional drug \[225Ac\]Ac-A9-3408 will be administered intravenously (IV) once every 6 weeks, for a total of up to 6 cycles.

Conditions

• Melanoma Metastatic
• Uveal Melanoma, Metastatic
• Mucosal Melanoma

Interventions

Type	Name	Description
DRUG	[225Ac]Ac-A9-3408	Administered IV
DIAGNOSTIC_TEST	[68Ga]Ga-A9T-3202	Administered IV

Timeline

• Start date: 2025-11-19
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-07-22
• Last updated: 2026-03-16

Locations

4 sites across 1 country: Australia