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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 (mCRPC). It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with metastatic castration-resistant prostate cancer.
Ac-AKY-2519 targets B7H3, a protein that is expressed in certain cancers. The drug is designed to deliver a radioactive payload, actinium-225, to B7H3-expressing tumor cells. This targeted approach is being evaluated in a Phase 1 clinical trial for metastatic castration-resistant prostate cancer.
Ac-AKY-2519 is being developed by Aktis Oncology, Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol AKTS. Aktis Oncology is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of Ac-AKY-2519 in patients with metastatic castration-resistant prostate cancer.
Ac-AKY-2519 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients with metastatic castration-resistant prostate cancer to assess the drug's safety, tolerability, and preliminary efficacy.
Ac-AKY-2519 is being studied in a Phase 1 clinical trial with the identifier NCT07581184. The trial, titled 'A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer,' is currently recruiting participants in the United States. The study aims to enroll 138 male patients aged 18 years and older.
Yes, Ac-AKY-2519 is the same as [225Ac]Ac-AKY-2519. The latter name specifies the therapeutic form of the drug, which includes the radioactive isotope actinium-225. This radiolabeled version is the active therapeutic agent being evaluated in clinical trials for metastatic castration-resistant prostate cancer.