AdvanCell to Present Promising Clinical Trial Results of ADVC001, a Novel Lead-212-based PSMA-targeted Alpha Therapy for Prostate Cancer, at ESMO 2025

13.10.2025 01:31:00 CEST | Business Wire | Press Release

AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, announces a presentation at the European Society for Medical Oncology (ESMO) Congress, taking place in Berlin, Germany, from October 17-21, 2025.

The presentation will feature promising results from the Phase 1b dose escalation of the Phase 1/2 TheraPb study, evaluating ADVC001, a Lead-212-based PSMA-targeted alpha therapy, in metastatic castration-resistant prostate cancer (mCRPC).

This will be the first presentation of clinical data from a 212Pb-PSMA therapy at a major oncology conference – an important milestone in advancing targeted alpha therapies for prostate cancer and a clear demonstration of AdvanCell’s leadership in radioligand therapy. The abstract presents a favorable safety profile for 212Pb-ADVC001 and promising anti-tumor activity, underscoring the potential of 212Pb-ADVC001 to enhance therapeutic options for patients with metastatic prostate cancer.

The abstract is available online on the ESMO website (link), and features data as of a May 9, 2025 cut-off. The poster to be presented at ESMO will include updated safety and efficacy data and additional treatment cohorts.

Details of the abstract and presentation:

Results from the Phase 1b Dose Escalation of 212Pb-ADVC001 in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC): The TheraPb Trial

Presenter: Aaron Hansen, MD, BSc, MBBS, FRACP, Princess Alexandra Hospital, Brisbane, Australia
Presentation Number: 2388P
Session: Prostate Cancer Poster Session
Session Time/ Place: Saturday, October 18 / 12:00-12:45 PM CET / Hall 25
Poster Display Time: 9:00 AM – 5:00 PM CET

About the TheraPb trial

The TheraPb trial (NCT05720130) is a prospective, open-label Phase 1/2 dose-escalation and expansion study designed to determine the safety and tolerability of escalating doses of 212Pb-ADVC001 administered every 6, 4, 2 or 1 week(s) during the dose-finding Phase 1b. The Phase 2 expansion will assess the efficacy and safety of 212Pb-ADVC001 at the recommended Phase 2 doses across three indications. The trial incorporates randomization and dose optimization elements to rigorously evaluate optimal dosing strategies of 212Pb-ADVC001 in PSMA-positive mCRPC and in hormone-sensitive prostate cancer (mHSPC).

About 212Pb-ADVC001

212Pb-ADVC001 is a novel, proprietary and patented small molecule PSMA-targeting radioligand with optimized physicochemical properties labelled with 212Pb, an alpha-emitting payload (radionuclide) with a high dose rate, short half-life (10.6 hours) and simple decay scheme. 212Pb-ADVC001 is designed to deliver radiation at a cellular level to more effectively kill prostate cancer cells while minimizing toxicity.

About AdvanCell

AdvanCell is a vertically integrated, clinical-stage radiopharmaceutical company dedicated to developing innovative cancer therapies that harness the power of targeted alpha-emitting radionuclides. By leveraging its proprietary Lead-212 platform, advanced and scalable manufacturing capabilities, cutting-edge science and world-class clinical development capabilities, AdvanCell aims to deliver novel treatments that improve outcomes for patients with cancer globally.

For more information, visit www.advancell.com.au and follow us on LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251013316172/en/

Contacts

Andrew Adamovich, CEO
contact@advancell.com.au

For media inquiries, please contact:
MEDiSTRAVA
Mark Swallow, Frazer Hall, Sylvie Berrebi
advancell@medistrava.com
+44 (0)20 3928 6700

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