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- Results from the TheraPb Phase 1b dose escalation presented at ESMO 2025 show a promising therapeutic index for 212Pb-ADVC001 in patients with metastatic castration-resistant prostate cancer (mCRPC)
- No dose-limiting toxicities and no treatment-related serious adverse events observed
- Xerostomia predominantly Grade 1
- 80% PSA50 response at doses ≥ 160 MBq
- 100% objective response rate (ORR) in patients with RECIST-measurable lesions, including two complete responses (CRs)
- The data represent the first clinical trial results for a Lead-212 (212Pb)-based PSMA-targeted radioligand therapy and highlight the potential of 212Pb-ADVC001 to enhance therapeutic options for patients with prostate cancer
- Phase 2 expansion will evaluate 160 MBq and 200 MBq of 212Pb-ADVC001 using a randomized multi-dose-response design and adaptive dosing strategies to optimize clinical outcomes in three indications: mCRPC (chemo-naïve, and post-177Lu-PSMA) and hormone-sensitive prostate cancer (mHSPC)
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SYDNEY — AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, presented results from the Phase 1b dose escalation of the TheraPb Phase 1/2 clinical trial ( NCT05720130) at the European Society for Medical Oncology (ESMO) 2025 congress. The presentation featured the first clinical results of 212Pb-ADVC001, a novel Lead-212-based PSMA-targeted alpha therapy in mCRPC.
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“We are very encouraged by the completion of the treatment period of our Phase 1 trial, which has demonstrated a favorable safety profile and compelling anti-tumor activity for 212Pb-ADVC001,”
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said
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Anna Karmann, MD PhD, Chief Medical Officer of AdvanCell
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.
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“These results underscore the potential of our therapy to meaningfully impact patients’ lives and advance treatment options in metastatic prostate cancer. I want to sincerely thank the investigators, clinical teams, and most importantly the patients and their families, whose commitment has made this important milestone possible.”
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“The TheraPb Phase 1 trial of 212Pb-ADVC001 marks a pivotal step forward in the evolution of PSMA-targeted radioligand therapy
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,” said
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Aaron Hansen, MD, Principal Investigator at Princess Alexandra Hospital
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. “
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We’ve observed a compelling therapeutic index, including marked reductions in tumor volume and PSA, alongside a promising safety and dosimetry profile. The ability to administer alpha therapy easily and efficiently in an outpatient setting is a major clinical advantage. I am excited about the potential of 212Pb-ADVC001 to redefine treatment for patients with prostate cancer.
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”
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Oliver Sartor, MD, Director of the Transformational Prostate Cancer Research Center at East Jefferson General Hospital
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, remarked, “
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The results from this Phase 1 trial demonstrate a strong efficacy signal combined with an excellent safety profile. This is an extremely promising step forward in delivering targeted alpha therapy to patients with prostate cancer
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.”
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The abstract submitted to ESMO was based on a data cut-off as of May 9, 2025. The presentation at ESMO includes updated safety and efficacy data from all seven treatment cohorts as of an October 2, 2025 cut-off.
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The TheraPb Phase 1b dose escalation study enrolled 22 patients with mCRPC. Escalating doses of 60–200 MBq of 212Pb-ADVC001 were administered at prespecified schedules every 6, 4, 2 and 1 week(s) for up to six cycles. After cohort 1, six subsequent treatment cohorts were enrolled within ten months.
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TheraPb Phase 1b dose escalation results as of October 2, 2025 cut-off:
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Encouraging safety and tolerability
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- No dose-limiting toxicities, treatment-related serious adverse events or treatment-related adverse events leading to dose modification or treatment discontinuation
- Xerostomia predominantly Grade 1, with evidence of reversibility
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Promising anti-tumor activity
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- 80% PSA50 biochemical response at therapeutic doses ≥ 160 MBq
- 100% ORR in patients with RECIST-measurable lesions, including two CRs
- PSA, imaging and clinical responses within weeks of treatment start
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Favorable dosimetry and kinetics
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- Low normal-organ radiation exposure that supports a dosing strategy beyond six cycles and enhanced dose intensity
- Fast clearance and no relevant metabolic breakdown
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The data represent the first clinical trial results of a 212Pb-based PSMA therapy. The findings support the further development of 212Pb-ADVC001 and may offer a new reference point in the treatment landscape for metastatic prostate cancer, both within and beyond the PSMA-targeted class.
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Phase 2 expansion will evaluate 160 MBq and 200 MBq of 212Pb-ADVC001 using a randomized multi-dose-response design and adaptive dosing strategies to optimize clinical outcomes in three indications: mCRPC (chemo-naïve, and post-177Lu-PSMA) and mHSPC.
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The poster presentation is available on AdvanCell’s website at: AdvanCell ESMO 2025 Poster xxx
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About the TheraPb trial
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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 utilizes a randomized dose-response design and dose optimization elements to rigorously evaluate optimal dosing strategies of 212Pb-ADVC001 in PSMA-positive mCRPC and mHSPC.
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About 212Pb-ADVC001
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212Pb-ADVC001 is a proprietary and patented PSMA-targeting radioligand with optimized physicochemical properties and 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.
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