Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-28 @ 5:08 AM
Study NCT ID:
NCT07076550
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma
Sponsor:
Alpha-9 Oncology USA Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: