Phase 1-1b test of A9-3408 for unresectable or metastatic melanoma
A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of [225Ac]Ac-A9-3408 in Subjects With Unresectable or Metastatic Melanoma
This trial tests an experimental radiopharmaceutical called A9-3408 given every 6 weeks to see if it is safe and can shrink tumors in adults with unresectable or metastatic melanoma who have progressed on prior therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alpha-9 Oncology USA Inc. Industry-sponsored |
| Locations | 4 sites (Melbourne, Victoria and 3 other locations) |
| Trial ID | NCT07076550 on ClinicalTrials.gov |
What this trial studies
This open-label, multicenter Phase 1–1b trial gives an actinium-225–labeled radiopharmaceutical (A9-3408) intravenously once every 6 weeks for up to six cycles to adults with unresectable or metastatic melanoma. A Ga-68 diagnostic PET tracer is administered during screening to confirm uptake in at least one measurable lesion before dosing. The Phase 1 portion uses dose-escalation and organ/tumor dosimetry to define safety, tolerability, and a recommended Phase 2 dose; Phase 1b treats an expansion cohort at that dose in patients with prior progression on anti–PD-1/PD-L1 therapy. Regular clinic visits include safety labs, imaging, and dosimetry assessments to monitor side effects and tumor response.
Who should consider this trial
Good fit: Adults with unresectable or metastatic melanoma that shows uptake on the required Ga-68 PET scan, who have measurable disease and prior progression on standard treatments including anti–PD-1/PD-L1 therapy, are the intended candidates.
Not a fit: Patients without tracer uptake on Ga-68 PET, those previously treated with therapeutic radioactive nuclides, or those with inadequate organ function or poor performance status are unlikely to benefit from this investigational treatment.
Why it matters
Potential benefit: If successful, this targeted alpha therapy could shrink tumors and offer a new treatment option for patients whose melanoma has progressed after standard therapies.
How similar studies have performed: Targeted radiopharmaceuticals and alpha-emitter therapies have shown promising signals in early-phase trials for some cancers, but this specific actinium-225 A9-3408 agent is novel and not yet proven in melanoma.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. 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: * 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
Where this trial is running
Melbourne, Victoria and 3 other locations
- Alfred Health — Melbourne, Victoria, Australia (Recruiting)
- Austin Health — Melbourne, Victoria, Australia (Recruiting)
- Fiona Stanley Hospital — Murdoch, Western Australia, Australia (Not_yet_recruiting)
- GenesisCare Murdoch — Murdoch, Western Australia, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Sam Vohra
- Email: sam@avionmedical.com.au
- Phone: +61 300 131 548
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.