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.

Trial Details

NCT ID
NCT05720130
Phase
PHASE1 / PHASE2
Sponsor
AdvanCell Pty Limited
Status
RECRUITING
Cancer Type
Hormone-Sensitive Prostate Cancer
Interventions
  • [²¹²Pb]Pb-ADVC001 (Phase 1b)
  • [²¹²Pb]Pb-ADVC001 (Phase 2a)
Locations (sample)
  • Brisbane, Queensland, Australia|-27.46794,153.02809
  • Brisbane, Queensland, Australia|-27.46794,153.02809
  • Southport, Queensland, Australia|-27.96724,153.39796

Key Eligibility Criteria

  • Documented metastatic adenocarcinoma of the prostate, confirmed by histopathology.
  • Progressive metastatic prostate cancer demonstrated by at least one of the following:
  • Increase in PSA greater than 25% and \> 2 ng/mL above nadir, confirmed by progression at two timepoints at least three weeks apart
  • Progressive disease or new lesion(s) (relative to previous imaging) in the viscera or lymph nodes as per the Response Evaluation Criteria in Solid …

For full eligibility, visit ClinicalTrials.gov.

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