Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT07076550
Brief 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.
Study:
NCT07076550
Study Brief:
Protocol Section:
NCT07076550