Approval Probability
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ML Risk
Also known as [225Ac]Ac-A9-3408
Ac-A9-3408 · 1 trial · 3 indications
Rate of DLTs per dose level/cohort
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
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| [225Ac]Ac-A9-3408 | DRUG | Administered IV |
| [68Ga]Ga-A9T-3202 | DIAGNOSTIC_TEST | Administered IV |
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 * Ad...
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Ac-A9-3408 is an investigational small molecule being developed for the treatment of metastatic melanoma, including uveal melanoma and mucosal melanoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Ac-A9-3408 is a radiopharmaceutical that incorporates the radioisotope actinium-225. It is designed to deliver targeted radiation to cancer cells, though its specific molecular target has not been disclosed.
Ac-A9-3408 is being developed by BrainsWay Ltd., a company traded on the stock exchange under the ticker BWAY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with metastatic melanoma.
Ac-A9-3408 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is recruiting participants to assess safety, efficacy, and dosimetry.
Ac-A9-3408 is being studied in a Phase 1-1b clinical trial with the identifier NCT07076550. This trial is recruiting 50 participants in Australia and is evaluating the drug in patients with metastatic melanoma, including uveal and mucosal melanoma. The study is currently recruiting.
Yes, Ac-A9-3408 is also known as [225Ac]Ac-A9-3408. Both names refer to the same investigational drug, which incorporates the radioactive isotope actinium-225. This alternative name is used in scientific and clinical contexts to specify the radiolabeled form of the compound.