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

via Business Wire
  • Results from the Phase 1b dose escalation of the TheraPb Phase 1/2 trial are the first clinical data for a Lead-212 (212Pb)-based-PSMA radioligand therapy
  • The abstract presents a favorable safety profile for 212Pb-ADVC001 and promising anti-tumor activity, underscoring its potential to enhance therapeutic options for patients with metastatic prostate cancer
  • The upcoming presentation at ESMO will feature updated safety and efficacy results from all seven Phase 1b treatment cohorts

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.

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