A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma
NCT ID: NCT07076550
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2025-11-19
2028-01-31
Brief Summary
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* 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
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1 Dose Escalation
Participants enrolled in Dose Escalation will receive a single dose of the investigational diagnostic agent \[68Ga\]Ga-A9T-3202 during screening, and receive the investigational treatment \[225Ac\]Ac-A9-3408 once every 6 weeks, for up to 6 total cycles.
[225Ac]Ac-A9-3408
Administered IV
[68Ga]Ga-A9T-3202
Administered IV
Phase 1B Dose Expansion
Participants enrolled in Dose Expansion will receive a single dose of the investigational diagnostic agent \[68Ga\]Ga-A9T-3202 during screening, and receive the investigational treatment \[225Ac\]Ac-A9-3408 once every 6 weeks, for up to 6 total cycles.
[225Ac]Ac-A9-3408
Administered IV
[68Ga]Ga-A9T-3202
Administered IV
Interventions
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[225Ac]Ac-A9-3408
Administered IV
[68Ga]Ga-A9T-3202
Administered IV
Eligibility Criteria
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Inclusion Criteria
* \[68Ga\]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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Alpha-9 Oncology USA Inc.
INDUSTRY
Responsible Party
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Locations
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Alfred Health
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
GenesisCare Murdoch
Murdoch, Western Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Dr. Malaka Ameratunga
Role: primary
Dr. Zeyad Al-Ogaili
Role: primary
Prof Joe Cardaci
Role: primary
Other Identifiers
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A9-3408-01
Identifier Type: -
Identifier Source: org_study_id