Actively Recruiting
Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).
Led by AdvanCell Pty Limited · Updated on 2026-02-20
100
Participants Needed
3
Research Sites
324 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented metastatic adenocarcinoma of the prostate confirmed by histopathology
- Progressive metastatic prostate cancer shown by increased PSA or new lesions on imaging
- For Phase 1b: metastatic castration-resistant prostate cancer with prior ARPi and taxane chemotherapy exposure (unless contraindicated or declined)
- For Phase 2a Group 1: metastatic hormone-sensitive prostate cancer with sub-optimal PSA response despite ADT and ARPi, no disease progression
- For Phase 2a Group 2: progressive metastatic castration-resistant prostate cancer, post at least one ARPi, 177Lu-PSMA-naive, no prior chemotherapy for CRPC
- For Phase 2a Group 3: progressive metastatic castration-resistant prostate cancer with prior 177Lu-PSMA and ARPi exposure
- PSMA-positive disease confirmed by specific PET/CT imaging criteria
- ECOG Performance Status 0 or 1
- Adequate blood, kidney, and liver function
You will not qualify if you...
- Prior systemic radioligand therapy except prior radium-223; prior 177Lu-PSMA required for Phase 2a Group 3
- Systemic anti-cancer or radiation therapy within 4 weeks before first dose or investigational agent within 4 weeks before first dose
- Other malignancies within 3 years except those with negligible metastasis risk
- Known central nervous system metastases or symptoms/signs of spinal cord compression unless stable off steroids for 4 weeks
- Diffuse bone marrow involvement defined as superscan on bone scintigraphy
- Serious active or subclinical infection, angina, severe heart failure (NYHA III or IV), prolonged QT interval, or other serious illness impairing participation
- Known BRCA1 or BRCA2 gene alterations eligible for PARP inhibitor therapy according to standard care
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Royal Brisbane & Women's Hospital
Brisbane, Queensland, Australia, 4029
Actively Recruiting
2
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Actively Recruiting
3
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Actively Recruiting
Research Team
A
Anna Karmann
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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