AdvanCell Advances Prostate Cancer Therapy with Phase 2 Trial of 212Pb-ADVC001
BRISBANE, Australia & BOSTON – February 24, 2026 – AdvanCell, a clinical-stage radiopharmaceutical company, announced the design of a Phase 2 trial for ADVC001, an investigational Lead-212-based therapy targeting prostate-specific membrane antigen (PSMA) in metastatic prostate cancer. The trial’s design will be presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2026) in San Francisco, CA.1
Novel Dosing Strategy for Improved Outcomes
The TheraPb Phase 2 trial is an open-label, randomized expansion study designed to optimize dosing strategies across three patient groups: those with metastatic hormone-sensitive prostate cancer (mHSPC), castration-resistant prostate cancer (mCRPC) before chemotherapy, and mCRPC after 177Lu-PSMA radioligand therapy.2 This innovative approach builds upon promising Phase 1b results, which demonstrated encouraging safety and anti-tumor activity.
Promising Phase 1b Results
In the Phase 1b dose escalation, 80% of patients achieved a 50% reduction in prostate-specific antigen (PSA50). A 100% objective response rate (ORR) was observed in patients with measurable lesions, including two complete responses (CRs). Importantly, no dose-limiting toxicities or treatment-related serious adverse events were reported.1 ADVC001 also exhibited favorable pharmacokinetic properties, including rapid tumor uptake, fast renal clearance, and low exposure to normal organs.1
Adaptive Dosing and Extended Treatment
The Phase 2 trial incorporates a novel dosing strategy that includes more frequent initial treatment, leveraging the 10.6-hour half-life of Lead-212, and adjusts treatment based on individual patient responses.2 Participants will be randomized to receive either 160 or 200 MBq of ADVC001, with up to four initial doses. Additional doses may be administered as maintenance therapy, potentially totaling up to 12 doses, with treatment pauses based on individual response.2
Expert Perspectives
“This approach is the first in the next generation of radioligand therapy trials that goes beyond standard dosing strategies in order to improve patient outcomes,” said Thomas Hope, MD, Vice Chair Clinical Operations and Strategy, Department of Radiology and Biomedical Imaging, University of California San Francisco.2
Michael J. Morris, MD, Prostate Cancer Section Head, Genitourinary Oncology, Memorial Sloan Kettering Cancer Center, commented, “ADVC001 is a promising alpha PSMA-directed theranostic treatment…The study examines the merits of a treatment intensification strategy, adaptive dosing, and application across multiple clinical settings.”2
Trial Details and Presentation
The TheraPb Phase 2 trial (NCT05720130) is currently open at clinical sites in Australia, with plans to expand to the United States.2 Results will be presented in a ‘Trials in Progress’ poster at ASCO GU 2026.
- Presentation Title: Phase 2 Expansion Study of 212Pb-ADVC001 in Metastatic Prostate Cancer: The TheraPb Trial
- Presenter: Professor Aaron Hansen, Princess Alexandra Hospital, Brisbane, Australia
- Abstract Number: TPS280, Board N16
- Date and Time: February 26, 2026 – 11:30 AM – 12:45 PM and 5:45 PM – 6:45 PM Pacific Time
About 212Pb-ADVC001
212Pb-ADVC001 is a patented PSMA-targeting radioligand utilizing Lead-212, an alpha-emitting radionuclide designed to deliver targeted radiation to kill prostate cancer cells while minimizing toxicity.2
For more information, visit www.advancell.com.au.