Melanoma MetastaticPhase 1NCT07076550
A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma
A Phase 1 study testing [225Ac]Ac-A9-3408 and [68Ga]Ga-A9T-3202 in people with Melanoma Metastatic and Uveal Melanoma, Metastatic, run by Alpha-9 Oncology USA Inc. at 4 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Metastatic, Uveal Melanoma, Metastatic, Mucosal Melanoma
- What is being tested?
- [225Ac]Ac-A9-3408 and [68Ga]Ga-A9T-3202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 4 sitesAustralia
- Study dates
- 19 Nov 2025to 9 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Alfred Health
Melbourne, Victoria, 3004
Austin Health
Melbourne, Victoria, 3084
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
GenesisCare Murdoch
Murdoch, Western Australia, 6150
About this study
Official 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
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
Read the detailed description
This is a multicenter, open-label Phase 1-1b study of [225Ac]Ac-A9-3408 in subjects with unresectable or metastatic melanoma.
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.
- Being tested
- [225Ac]Ac-A9-3408, [68Ga]Ga-A9T-3202
- Keywords
- Metastatic Melanoma, Melanoma, Radiopharmaceuticals, Theranostic
- Medical subject headings
- Uveal Melanoma, Neoplasm Metastasis, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[225Ac]Ac-A9-3408Drug
Administered IV
[68Ga]Ga-A9T-3202Diagnostic test
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | 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. Receives: Drug: [225Ac]Ac-A9-3408; Diagnostic Test: [68Ga]Ga-A9T-3202 |
| Phase 1B Dose Expansion | Experimental | 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. Receives: Drug: [225Ac]Ac-A9-3408; Diagnostic Test: [68Ga]Ga-A9T-3202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine max tolerated dose and recommended Phase 2 Dose
Rate of DLTs per dose level/cohort
Measured: First 28 days following first study treatment
Incidence of treatment-related adverse events
Rate and severity of suspected treatment-related adverse events, change from baseline laboratory values and change from baseline vital signs as graded by CTCAE version 5.0
Measured: From first study treatment until end of treatment
Secondary outcomes (2)
Evaluate the preliminary efficacy of [225Ac]Ac-A9-3408 by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Percent of patients who achieve an overall response (ORR), defined as the percent of patients who achieve a complete response (CR) or partial response (PR) by RECIST v1.1
Measured: Up to 1 year from enrollment
Evaluate biodistribution and normal organ dosimetry of [225Ac]Ac-A9-3408
Absorbed radiation dose estimates (Gy) in normal organs for [225Ac]Ac-A9-3408
Measured: Up to 7 days following each cycle (42 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start19 Nov 2025
- Primary completion9 Jul 2026
- Study completion9 Jul 2026
Why it stopped: Due to a strategic decision to re-prioritize the sponsor's existing portfolio.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpha-9 Oncology USA Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076550
- Sponsor's protocol ID
- A9-3408-01
- Status last verified
- Aug 2026
- First submitted
- 27 Jun 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07076550
- Acronym / sponsor ID
- A9-3408-01
- Keywords
- Metastatic Melanoma, Melanoma, Radiopharmaceuticals, Theranostic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a strategic decision to re-prioritize the sponsor's existing portfolio.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Alpha-9 Oncology USA Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 9 Jul 2026 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a multicenter, open-label Phase 1-1b study of [225Ac]Ac-A9-3408 in subjects with unresectable or metastatic melanoma.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | Drug: [225Ac]Ac-A9-3408, Diagnostic Test: [68Ga]Ga-A9T-3202Participants 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. |
| Phase 1B Dose Expansion | Experimental | Drug: [225Ac]Ac-A9-3408, Diagnostic Test: [68Ga]Ga-A9T-3202Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [225Ac]Ac-A9-3408Administered IV | Drug | Phase 1 Dose Escalation, Phase 1B Dose Expansion |
| [68Ga]Ga-A9T-3202Administered IV | Diagnostic test | Phase 1 Dose Escalation, Phase 1B Dose Expansion |
Primary outcome
Determine max tolerated dose and recommended Phase 2 Dose
Time frame: First 28 days following first study treatment
Rate of DLTs per dose level/cohort
Incidence of treatment-related adverse events
Time frame: From first study treatment until end of treatment
Rate and severity of suspected treatment-related adverse events, change from baseline laboratory values and change from baseline vital signs as graded by CTCAE version 5.0
2 secondary outcomes
Evaluate the preliminary efficacy of [225Ac]Ac-A9-3408 by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Up to 1 year from enrollment
Evaluate biodistribution and normal organ dosimetry of [225Ac]Ac-A9-3408
Time frame: Up to 7 days following each cycle (42 days)
Results and safety
The study was stopped early (reason given: Due to a strategic decision to re-prioritize the sponsor's existing portfolio.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Melanoma Metastatic
Active, not recruitingPhase 3
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
Active, not recruitingPhase 2/3
A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
Stage III Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [225Ac]Ac-A9-3408 and [68Ga]Ga-A9T-3202 in people with Melanoma Metastatic and Uveal Melanoma, Metastatic, run by Alpha-9 Oncology USA Inc. at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to a strategic decision to re-prioritize the sponsor's existing portfolio.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine max tolerated dose and recommended Phase 2 Dose (time frame: First 28 days following first study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.