Aktis Oncology posts presentation outlining AKY-2519 Phase 1b clinical development strategy

Aktis Oncology, Inc.

Aktis Oncology, Inc.

AKTS

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  • Aktis outlined a two-trial Phase 1b plan for AKY-2519, a B7-H3-targeted miniprotein radioconjugate, starting with a dedicated metastatic castration-resistant prostate cancer study.
  • mCRPC Phase 1b has been initiated, with dose escalation using a BOIN design and expansion cohorts planned for PLUVICTO-naive patients plus PLUVICTO-experienced patients.
  • Entry requires tumor uptake on imaging with [64Cu]Cu-AKY-2519, positioning trial to compare B7-H3 expression with PSMA expression.
  • Imaging and dosimetry datasets are slated for presentation at ASCO 2026, with preliminary mCRPC Phase 1b data expected in 2027.
  • Basket Phase 1b in B7-H3-expressing lung, colorectal, and other solid tumors is expected to start in 2H’26.


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