Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).
Recruiting
Phase 1
Phase 2
Interventional Study
Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Metastatic Hormone Sensitive Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- AdvanCell Pty Limited · Industry
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About This Trial
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-ADV…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Documented metastatic adenocarcinoma of the prostate, confirmed by histopathology.
* Progressive metastatic prostate cancer demonstrated by at least one of the following:
1. Increase in PSA greater than 25% and \> 2 ng/mL above nadir, confirmed by progression at two tim…
Contacts