AKTS
Aktis Oncology, Inc.[225Ac]Ac-AKY-1189 modulates Not specified in filing - actinium-225 alpha-emitting radiopharmaceutical to treat Multiple solid tumors including urothelial carcinoma, triple-negative breast cancer, HR+ breast adenocarcinoma, NSCLC, cervical adenocarcinoma, colorectal adenocarcinoma, and head and neck cancer.
moa:Alpha-emitting radiopharmaceutical using actinium-225 (a potent radionuclide) for targeted tumor irradiation; accompanied by [64Cu]Cu-AKY-1189 as a companion diagnostic for patient selection
Phase 1 non-randomized, single-arm dose-escalation study enrolling 150 patients across multiple solid tumor types; includes both therapeutic agent [225Ac]Ac-AKY-1189 and companion imaging agent [64Cu]Cu-AKY-1189; Part 1 focuses on DLTs and ORR, Part 2 focuses on adverse events
primary endpoint:Part 1: Number of Patients with Dose-Limiting Toxicities (DLTs) from enrollment through end of Cycle 1 (28-day cycles)
Not stated in provided filing data
- SEC filing content is extremely minimal (only contains '6') - insufficient corporate disclosure
- Target antigen not specified - unknown what molecule AKY-1189 binds to
- No stated mechanism of action details beyond being an alpha emitter
- No differentiation claims provided in available data
- Companion diagnostic mentioned but selection criteria not defined
- Very broad indication scope (7 different tumor types) in Phase 1 suggests exploratory/unfocused development strategy
- Not explicitly stated in filing - standard oncology trial risks assumed (toxicity, lack of efficacy)
- 2027-12Primary completion date