— The study employs a response-driven dosing strategy and expanded treatment across three prostate cancer populations, supported by positive Phase 1b clinical, pharmacokinetic, and dosimetric results —

Australia, Brisbane, Boston–BUSINESS WIRE–

Advancel, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, today announced a new Phase 2 design for its ongoing TheraPb clinical trial of ADVC001 in metastatic prostate cancer. ADVC001 is an investigational alpha therapy targeting lead-212-based prostate-specific membrane antigen (PSMA). The study design will be presented in the “Trials in Progress” poster at the American Society of Clinical Oncology Urinary Tract Cancer Symposium (ASCO GU 2026), to be held this week in San Francisco, California.

TheraPb Phase 2 is an open-label, randomized expansion study incorporating a dose optimization strategy in three groups of patients: metastatic hormone-sensitive (mHSPC) and castration-resistant prostate cancer (mCRPC). The innovative design of this study Phase 1b dose escalation resultsThis showed the promising safety and promising antitumor activity of ADVC001. At the recommended phase 2 dose, 80% of patients achieved a 50% reduction in prostate-specific antigen (PSA50), and a 100% overall response rate was observed in patients with evaluable tumors, while no dose-limiting toxicities or toxicity-related treatment discontinuations or dose changes were observed. ADVC001 showed rapid and high tumor uptake, rapid renal clearance, and low normal organ radiation exposure.

“The Phase 2 TheraPb trial employs a new dosing strategy that takes advantage of lead-212’s half-life and incorporates more frequent pretreatment to account for patient-specific responses.” “We are thrilled to be partnering with the Department of Radiology and Biomedical Imaging at the University of California, San Francisco,” said Thomas Hope, MD, associate director of clinical operations and strategy, Department of Radiology and Biomedical Imaging.. “This approach is the first in a next generation of radioligand therapy trials that go beyond standard dosing strategies to improve patient outcomes.”

“ADVC001 is a promising alpha PSMA-directed therapy using an innovative payload of lead-212.” Commented Michael J. Morris, M.D., Chief of the Division of Genitourinary Oncology and Prostate Cancer at Memorial Sloan Kettering Cancer Center.. “This study examines the benefits of treatment intensification strategies, adaptive dosing, and application across multiple clinical settings, with the support of a novel study design aimed at facilitating efficient development.”

“TheraPb Phase 2 incorporates a dose optimization strategy designed to improve patient outcomes in three distinct prostate cancer populations across a disease continuum with high unmet medical need.” “AdvanCell’s Chief Medical Officer, Anna Kallman, M.D., said:. “To maximize clinical benefit and minimize toxicity, we are investigating new dosing regimens aimed at optimizing the timing and duration of treatment. Driven by the positive safety and tolerability results of ADVC001 in Phase 1b, this study also includes evaluation of long-term treatment in participants who showed sustained benefit.”

The TheraPb Phase 2 expansion is designed to optimize development opportunities for ADVC001. Participants with mHSPC (suboptimal responders), mCRPC (pre-chemotherapy), and mCRPC (post-177Lu-PSMA) will be randomized to either 160MBq or 200MBq of ADVC001 and receive up to four doses of ADVC001 during dose-intensive induction. Additional doses may be administered as maintenance therapy for a total of up to 12 doses, and treatment may be paused (“treatment holidays”) based on individual response.

TheraPb Phase 2 Study (NCT05720130) has opened at a clinical site in Australia, with expansion to other sites in the United States planned.

Ongoing clinical trial poster at ASCO GU 2026

• Presentation title: Phase 2 expansion study of 212Pb-ADVC001 in metastatic prostate cancer: TheraPb trial
• Presenter: Professor Aaron Hansen, Princess Alexandra Hospital, Brisbane, Australia
• Summary number: TPS280, board N16
• session: Ongoing Clinical Trials Poster Session A: Prostate Cancer
• Date and time: February 26th – 11:30am – 12:45pm and 5:45pm – 6:45pm PT

This presentation is available on the AdvanCell website. www.advancell.com.au/presentations-publications.

About 212Pb-ADVC001

212Pb-ADVC001 (ADVC001) is a unique patented PSMA targeting radioligand labeled with lead-212 (212Pb), an alpha-emitting payload (radionuclide) with optimized physicochemical properties, high dose rate, 10.6 hour half-life, and simple decay scheme. ADVC001 is designed to deliver radiation at the cellular level, effectively killing prostate cancer cells with minimal toxicity.

About TheraPb test

TheraPb test (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 evaluated the safety and tolerability of escalating doses of ADVC001 administered every 6, 4, 2, or 1 week (See press release). The Phase 2 expansion is evaluating the efficacy and safety of ADVC001 at two dose levels. This study utilizes a randomized dose-response design and dose optimization elements to evaluate ADVC001 in PSMA-positive mCRPC and mHSPC.

About Advancel

AdvanCell is a vertically integrated, clinical-stage radiopharmaceutical company dedicated to developing innovative cancer treatments 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 new treatments that improve outcomes for cancer patients worldwide. For more information, please visit: www.advancell.com.au and follow us linkedin.

MSK Disclosure: Dr. Morris has financial interests related to AdvanCell.

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