Trial purpose
Cancer treatment
Tumor type
Skin
Age
18+
Clinical summary
Summary
The goal of this trial is to see if the investigational drug called [225Ac]Ac-A9-3408 is safe for adults with melanoma that has spread to other parts of the body (metastatic) or cannot be removed with surgery (unresectable). It will also see if the drug can shrink melanoma tumours in the body. The main questions this study aims to answer are:
- What are the side effects of the investigational drug?
- What is the highest dose of this 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
You may be eligible if you have unresectable and metastatic cutaneous melanoma and have disease progression while receiving an anti-PD-1/PD-L1-containing regimen.
Conditions
This trial is treating people with metastatic or unresectable melanoma
Eligibility
Inclusion
- 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
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Alpha-9 Oncology USA Inc.
Scientific 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
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