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Tests treatment safety and results for Melanoma Metastatic
Official title A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma
ClinicalTrials.gov ID: NCT07076550
What this study is testing
What is [225Ac]Ac-A9-3408?
[225Ac]Ac-A9-3408 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for melanoma metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
- Murdoch, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia; Murdoch, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.