AdvanCell Unveils Innovative Phase 2 Design for ADVC001 in Metastatic Prostate Cancer
Why are new treatment options for metastatic prostate cancer crucial? AdvanCell, a clinical-stage radiopharmaceutical company, is addressing this urgent need with its innovative targeted alpha therapy, ADVC001. Based in Australia, AdvanCell is dedicated to developing advanced cancer treatments that leverage the power of targeted alpha-emitting radionuclides.
AdvanCell has announced the novel Phase 2 design of the ongoing TheraPb clinical trial of ADVC001 in metastatic prostate cancer. The study, which will be showcased at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2026) in San Francisco, CA, incorporates dose optimization strategies to improve patient outcomes. “The Phase 2 TheraPb trial employs a novel dosing strategy that incorporates more frequent up-front treatment leveraging the half-life of Lead-212, as well as taking into account patient-specific responses,” commented Thomas Hope, MD, Vice Chair Clinical Operations and Strategy, Department of Radiology and Biomedical Imaging, University of California San Francisco.
Key Insights at a Glance
- Phase 2 Design: The TheraPb Phase 2 is an open-label, randomized expansion study incorporating dose optimization strategies.
- Safety and Efficacy: At the recommended Phase 2 dose, 80% of patients achieved a 50% reduction in PSA50, and a 100% overall response rate was observed.
- Dosing Strategy: The trial employs a novel dosing strategy that includes up to 4 doses during a dose-intense induction and up to 12 doses in total.
- Clinical Sites: The TheraPb Phase 2 trial is open at clinical sites in Australia, with planned expansion to the United States.
The Urgency of Advanced Prostate Cancer Treatment
Advanced prostate cancer remains a significant challenge, with limited treatment options and high unmet medical needs. AdvanCell is addressing this gap by developing ADVC001, a PSMA-targeted alpha therapy that has shown promising results in Phase 1b trials. The innovative dosing strategy in the Phase 2 trial aims to optimize treatment efficacy while minimizing toxicity. Just as a skilled surgeon must balance precision and speed, AdvanCell is meticulously refining its dosing protocols to maximize patient outcomes. The next step is the presentation of the Phase 2 design at ASCO GU 2026, which will provide critical insights into the future of this promising therapy.
AdvanCell’s Strategic Approach to Clinical Development
AdvanCell is committed to advancing the treatment landscape for metastatic prostate cancer with its novel PSMA-targeted alpha therapy, ADVC001. The TheraPb Phase 2 trial is designed to evaluate the efficacy and safety of ADVC001 in three distinct prostate cancer populations: metastatic hormone-sensitive (mHSPC), castration-resistant (mCRPC) pre-chemotherapy, and mCRPC post-177Lu-PSMA. “ADVC001 is a promising alpha PSMA-directed theranostic treatment that uses an innovative payload of Lead-212,” commented Michael J. Morris, MD, Prostate Cancer Section Head, Genitourinary Oncology, Memorial Sloan Kettering Cancer Center.
The trial’s innovative design, which includes dose optimization and adaptive dosing, is intended to facilitate efficient development and improve patient outcomes. AdvanCell will continue to evaluate extended treatment in participants who demonstrate ongoing benefit, ensuring a comprehensive approach to clinical development.
Future Outlook
The TheraPb Phase 2 trial represents a significant step forward in the development of targeted alpha therapies for metastatic prostate cancer. Just as a gardener carefully tends to a plant to ensure its growth, AdvanCell is meticulously refining its treatment protocols to maximize the potential of ADVC001. The trial’s innovative design and promising Phase 1b results suggest a robust foundation for further clinical advancement. The presentation at ASCO GU 2026 will provide valuable insights into the future of this therapy, with the trial expected to expand to additional sites in the United States.
Conclusion
The announcement of the TheraPb Phase 2 trial underscores AdvanCell‘s commitment to developing innovative treatments for advanced prostate cancer. By leveraging the unique properties of Lead-212 and employing a novel dosing strategy, AdvanCell is poised to make a significant impact on patient outcomes. Join the conversation in the comments below.
About 212Pb-ADVC001
212Pb-ADVC001 (ADVC001) is a proprietary and patented PSMA-targeting radioligand with optimized physicochemical properties and labelled with Lead-212 (212Pb), an alpha-emitting payload (radionuclide) with a high dose rate, 10.6-hour half-life and simple decay scheme. ADVC001 is designed to deliver radiation at a cellular level to effectively kill prostate cancer cells while minimizing toxicity.
About the TheraPb trial
The TheraPb trial (NCT05720130) is a prospective, open-label Phase 1/2 dose escalation and expansion study evaluating ADVC001 in metastatic prostate cancer. The completed Phase 1b dose escalation assessed the safety and tolerability of escalating doses of ADVC001 administered every 6, 4, 2 or 1 week(s) (see press release). The Phase 2 expansion is assessing the efficacy and safety of ADVC001 at two dose levels. The trial utilizes a randomized dose-response design and dose optimization elements to evaluate ADVC001 in PSMA-positive mCRPC and in mHSPC.
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 and world-class clinical development capabilities, AdvanCell aims to deliver novel treatments that improve outcomes for patients with cancer globally.
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