Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).
Recruiting now · Phase 1/Phase 2
Conditions studied: Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT05720130
- Run by
- AdvanCell Pty Limited
- People needed
- 100
- Starts
- 2023-03-15
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-02-20
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Royal Brisbane & Women's Hospital — Brisbane, Queensland, Australia (enrolling)
- Princess Alexandra Hospital — Brisbane, Queensland, Australia (enrolling)
- Gold Coast University Hospital — Southport, Queensland, Australia (enrolling)
Full record on ClinicalTrials.gov
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