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Also known as [225Ac]Ac-AKY-2519 (therapeutic)
Ac-AKY-2519 · 1 trial · 5 indications
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE and the number of patients experiencing an SAE will be reported. Up to 30 days following last administration of \[225Ac\]Ac-AKY-2519
Dose-limiting toxicities (DLTs) is defined as any predefined AE occurring during the DLT observation period, except those that are clearly and incontrovertibly due to extraneous circumstances. The number of patients who experience a DLT will be reported separately for each cohort and by dose level within each cohort.
| Arm | Type | Description |
|---|---|---|
| [225Ac]Ac-AKY-2519 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| [225Ac]Ac-AKY-2519 (therapeutic) | DRUG | \[225Ac\]Ac-AKY-2519 Injection |
| [64Cu]Cu-AKY-2519 (imaging) | DRUG | \[64Cu\]Cu-AKY-2519 Injection |
Inclusion Criteria: * Age ≥ 18 years * Histologic or cytologic confirmation of prostatic adenocarcinoma * ECOG Performance Status of 0 or 1 * Adequate end-organ function * Ability to give informed consent and comply with study requirements * Patients with CNS metastases are eligible if they have re...
Ac-AKY-2519 is an investigational small molecule being developed for the treatment of castration resistant metastatic prostate cancer, also known as mCRPC. It is currently in Phase 1 clinical development and has not been approved by the FDA.
Ac-AKY-2519 targets B7-H3, a protein that is expressed on the surface of many cancer cells. By targeting B7-H3, the drug is designed to deliver a therapeutic payload to cancer cells, potentially inhibiting tumor growth.
Ac-AKY-2519 is being developed by Aktis Oncology, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol AKTS.
Ac-AKY-2519 is in Phase 1 clinical development. It is an investigational drug and has not yet received FDA approval. The ongoing Phase 1 trial is recruiting patients with metastatic castration-resistant prostate cancer.
Ac-AKY-2519 is being studied in a Phase 1 clinical trial with the identifier NCT07581184. This trial is recruiting patients with metastatic castration-resistant prostate cancer and is being conducted in the United States.
Yes, Ac-AKY-2519 is also known as [225Ac]Ac-AKY-2519, which refers to the therapeutic form of the drug. This alternative name is used in clinical trial documentation to specify the radiolabeled version being tested.