Prostate Cancer; AB001 (PSMA-targeted Alpha Radioligand Therapy)

ARTBIO, Inc.; first patient dosed on 25 Nov 2025 under a Phase 1 trial for metastatic castration-resistant prostate cancer (mCRPC).

Trial cleared by FDA after IND approval.

AB001 is a PSMA-targeted radioligand therapy (RLT) labelled with alpha emitter Lead-212 (Pb-212).

Radioligand therapies deliver radioactive particles directly to tumour cells that express the target (PSMA), enabling high-energy DNA damage; alpha particles cause double-stranded DNA breaks in tumour cells, while their short tissue range helps spare healthy tissue.

Preclinical and Phase 0 data suggested AB001 could have better tumour targeting, higher damage efficiency and lower off-target toxicity compared to older therapies.

For mCRPC patients; often resistant to conventional therapies; this could represent a new therapeutic pathway, potentially improving outcomes and offering hope where options are limited.

Safety, tolerability, optimal dose escalation, biodistribution and initial signals of efficacy.