A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlpha-9 Oncology USA Inc.
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- [225Ac]Ac-A9-3408
- [68Ga]Ga-A9T-3202
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov