Clinical TrialMay 4, 2026, 04:08 PM
Aktis Oncology Initiates Phase 1b Trial for AKY-2519 in mCRPC
AI Summary
Aktis Oncology, Inc. announced the initiation of a Phase 1b clinical trial for AKY-2519, a B7-H3 targeted radiopharmaceutical, in patients with metastatic castration-resistant prostate cancer (mCRPC). This is part of a two-trial development strategy, which includes a second Phase 1b basket trial for other B7-H3 expressing solid tumors planned for the second half of 2026. Preliminary data from the mCRPC trial are expected in 2027, aiming to evaluate AKY-2519 broadly and efficiently generate indication-relevant data.
Key Highlights
- Aktis Oncology initiated a Phase 1b clinical trial for AKY-2519 in metastatic castration-resistant prostate cancer (mCRPC).
- The mCRPC trial will enroll both PLUVICTO®-naïve and -experienced patients across three dose levels.
- A second Phase 1b basket trial for lung, colorectal, and other high B7-H3 expressing solid tumors is planned for H2 2026.
- Preliminary data from the mCRPC trial are expected in 2027.
- AKY-2519 is a B7-H3 targeted miniprotein radioconjugate, the second miniprotein Aktis has advanced to the clinic.
- Aktis' lead program, AKY-1189, targeting Nectin-4, is also in Phase 1b, with preliminary data anticipated in Q1 2027.
- Aktis will host a conference call on May 5, 2026, to discuss the AKY-2519 clinical development strategy.
Price Impact
More from AKTS