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Also known as [225Ac]Ac-AKY-2519 (therapeutic)
Ac-AKY-2519 · 2 trials · 14 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.
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
Part 2: Objective Response Rate (ORR) • Objective response rate is defined as the percentage of patients who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator based on RECIST v1.1. Up to 30 days following last administration of \[225Ac\]Ac-AKY-2519
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 locally advanced or metastatic NSCLC, ES-SCLC, HNSCC, ESCC, CRC or prostatic adenocarcinoma * Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1 * ECOG Performance Status of 0 or 1 * Ad...
Ac-AKY-2519 is an investigational small molecule therapeutic developed by Aktis Oncology for B7-H3 expressing solid tumors. It is being studied in Phase 1 clinical trials in castration resistant metastatic prostate cancer and non-small cell lung cancer, and it has not been approved by the FDA.
Ac-AKY-2519 targets B7-H3, a protein expressed on a range of solid tumors. By binding B7-H3, the agent is designed to deliver its therapeutic payload to B7-H3 expressing cancer cells. Its clinical program enrolls patients whose tumors express B7-H3.
Ac-AKY-2519 is being studied for castration resistant metastatic prostate cancer and non-small cell lung cancer. Its Phase 1 trials also list extensive stage small cell lung cancer, head and neck squamous cell carcinoma, esophageal cancer, and colorectal cancer among the conditions under investigation.
Ac-AKY-2519 is developed by Aktis Oncology, Inc., which trades under the ticker AKTS. The company is running the Phase 1 program for the asset in the United States.
Ac-AKY-2519 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program consists of two recruiting Phase 1 studies, one in B7-H3 expressing solid tumors and one in metastatic castration-resistant prostate cancer.
Ac-AKY-2519 is being evaluated in two recruiting Phase 1 trials. NCT07887971 studies [225Ac]Ac-AKY-2519 in patients with B7-H3 expressing solid tumors, with planned enrollment of 152. NCT07581184 studies it in metastatic castration-resistant prostate cancer, with planned enrollment of 138 men.
Yes. [225Ac]Ac-AKY-2519 is the therapeutic form of Ac-AKY-2519, and the two names refer to the same Aktis Oncology asset. The bracketed designation appears in the trial titles for the Phase 1 studies in B7-H3 expressing solid tumors and metastatic castration-resistant prostate cancer.