AdvanCell, a clinical-stage radiopharmaceutical company, will present groundbreaking clinical data for ADVC001, the first Lead-212-based PSMA-targeted alpha therapy, at the European Society for Medical Oncology (ESMO) Congress in Berlin from October 17-21, 2025. The presentation marks the first time clinical data from a 212Pb-PSMA therapy will be featured at a major oncology conference.
Phase 1b Trial Results Show Promise
The presentation will showcase results from the Phase 1b dose escalation portion of the TheraPb Phase 1/2 trial, evaluating ADVC001 in patients with metastatic castration-resistant prostate cancer (mCRPC). According to the abstract, ADVC001 demonstrated a favorable safety profile and promising anti-tumor activity, highlighting its potential to enhance therapeutic options for patients with metastatic prostate cancer.
The poster presentation will include updated safety and efficacy data from all seven Phase 1b treatment cohorts, with data extending beyond the May 9, 2025 cut-off date featured in the abstract. Dr. Aaron Hansen from Princess Alexandra Hospital in Brisbane, Australia, will present the findings during the Prostate Cancer Poster Session on Saturday, October 18.
Novel Lead-212 Technology Platform
ADVC001 represents a novel approach to radioligand therapy, utilizing Lead-212 (212Pb) as its alpha-emitting payload. The radionuclide features a high dose rate, short half-life of 10.6 hours, and simple decay scheme. This combination is designed to deliver radiation at the cellular level to more effectively kill prostate cancer cells while minimizing toxicity to surrounding healthy tissue.
The drug is built on AdvanCell's proprietary and patented small molecule PSMA-targeting radioligand with optimized physicochemical properties, specifically engineered for the Lead-212 platform.
Comprehensive Trial Design
The TheraPb trial (NCT05720130) is structured as a prospective, open-label Phase 1/2 dose-escalation and expansion study. The Phase 1b portion focuses on determining the safety and tolerability of escalating doses of 212Pb-ADVC001 administered at varying intervals: every 6, 4, 2, or 1 week during the dose-finding phase.
The subsequent Phase 2 expansion will assess both efficacy and safety of 212Pb-ADVC001 at recommended Phase 2 doses across three different indications. The trial incorporates randomization and dose optimization elements to rigorously evaluate optimal dosing strategies in both PSMA-positive mCRPC and hormone-sensitive prostate cancer (mHSPC).
Industry Significance
This clinical milestone represents a significant advancement in targeted alpha therapy development and demonstrates AdvanCell's leadership position in radioligand therapy. The company operates as a vertically integrated radiopharmaceutical company with proprietary Lead-212 platform capabilities, advanced manufacturing infrastructure, and clinical development expertise focused on improving outcomes for cancer patients globally.
