Status: Recruiting
Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).
This is a prospective, open-label, dose-escalation and randomized dose optimization and expansion study. The Phase Ib portion of the study aims to determine the safety and tolerability of escalating doses of \[212Pb\]Pb-ADVC001 administered every 6, 4, 2 or 1 week(s) and establish the recommended phase 2 doses (RP2D). The Phase 2a expansion aims to assess the efficacy and safety of \[212Pb\]Pb-ADVC001 at the RP2 doses in 3 participant groups.
Participants needed: 100
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: MaleType: InterventionalSponsor: AdvanCell Pty LimitedUpdated: Feb 20, 2026Locations: 3
Eligibility criteria
Documented metastatic adenocarcinoma of the prostate, confirmed by histopatholog... [+9]
Has received prior systemic radioligand therapy with the exception of prior radi... [+6]