Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [225Ac]Ac-AKY-1189 (therapeutic)
Ac-AKY-1189 · 1 trial · 7 indications
• 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 in Part 1, will be reported by dose level.
• 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 in Part 1 will be reported.
• 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 1.1, by tumor types.
| Arm | Type | Description |
|---|---|---|
| [225Ac]Ac-AKY-1189 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| [225Ac]Ac-AKY-1189 (therapeutic) | DRUG | \[225Ac\]Ac-AKY-1189 Injection |
| [64Cu]Cu-AKY-1189 (imaging) | DRUG | \[64Cu\]Cu-AKY-1189 Injection |
Inclusion Criteria: * Histologic or cytologic confirmation of locally advance or metastatic disease * Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1 * ECOG Performance Status of 0 or 1 * Adequate end-organ function * Ability to give informed consent and comply...
Ac-AKY-1189 is an investigational small molecule being developed for the treatment of urothelial carcinoma of the bladder. It is also being studied in other solid tumors including triple negative breast cancer, hormone receptor positive breast adenocarcinoma, non-small cell lung cancer, cervical adenocarcinoma, colorectal adenocarcinoma, and head and neck cancer.
Ac-AKY-1189 targets Nectin-4, a cell surface protein. It is an actinium-225 labeled radiopharmaceutical designed to deliver targeted radiation to Nectin-4 expressing tumor cells. The therapeutic form is referred to as [225Ac]Ac-AKY-1189.
Ac-AKY-1189 is being developed by Aktis Oncology, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol AKTS.
Ac-AKY-1189 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Fast Track designation from the FDA for its development program.
Ac-AKY-1189 is being evaluated in a Phase 1 clinical trial with the identifier NCT07020117. This trial is recruiting participants with solid tumors, including urothelial carcinoma of the bladder, and is being conducted in the United States with a planned enrollment of 150 patients.
Yes, Ac-AKY-1189 and [225Ac]Ac-AKY-1189 refer to the same drug. The therapeutic form is designated as [225Ac]Ac-AKY-1189, indicating that it is labeled with the radioisotope actinium-225.