AdvanCell’s 212Pb-ADVC001 demonstrates encouraging safety and compelling anti-tumor activity in Phase 1b in prostate cancer
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)
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.
“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," said Anna Karmann, MD PhD, Chief Medical Officer of AdvanCell. “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.”
“The TheraPb Phase 1 trial of 212Pb-ADVC001 marks a pivotal step forward in the evolution of PSMA-targeted radioligand therapy,” said Aaron Hansen, MD, Principal Investigator at Princess Alexandra Hospital. “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.”
Oliver Sartor, MD, Director of the Transformational Prostate Cancer Research Center at East Jefferson General Hospital, remarked, “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.”
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.
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.
TheraPb Phase 1b dose escalation results as of October 2, 2025 cut-off:
Encouraging safety and tolerability
- 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
Promising anti-tumor activity
- 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
Favorable dosimetry and kinetics
- Low normal-organ radiation exposure that supports a dosing strategy beyond six cycles and enhanced dose intensity
- Fast clearance and no relevant metabolic breakdown
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.
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.
The poster presentation is available on AdvanCell’s website at: AdvanCell ESMO 2025 Poster
xxx
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 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.
About 212Pb-ADVC001
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.
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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20251020332206/en/
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Impartner Expands European Infrastructure to Accelerate Growth and Customer Support Across EMEA21.10.2025 10:00:00 CEST | Press release
Investment in European infrastructure strengthens Impartner’s EMEA operations and commitment to data security and regional growth Impartner, the leading provider of Partner Relationship Management (PRM) solutions, today announced the expansion of its European infrastructure with a new Azure-based data centre in the Netherlands. This milestone reflects Impartner’s accelerating success across the EMEA region and its commitment to providing customers with the highest levels of security, compliance, performance and support. “Our EMEA business continues to grow rapidly as companies across the region look to Impartner to scale their partner ecosystems,” said Curtis Brinkerhoff, CRO of Impartner. “Expanding our infrastructure within Europe, in close collaboration with Microsoft, ensures we are not only meeting strict EU data residency and privacy standards, but also strengthening performance and responsiveness for our customers across all industries.” By hosting in Microsoft’s Netherlands Azu
NTT DATA Strengthens Global Insurance Leadership with Acquisition of Alchemy Technology Services21.10.2025 10:00:00 CEST | Press release
NTT DATA, a global leader in AI, digital business and technology services, today announced the acquisition of Alchemy Technology Services, a specialist insurance technology consultancy. The move reinforces NTT DATA’s commitment to transforming the global insurance ecosystem, addressing current and emerging challenges around agility, modernization and scalability. In addition to its strong consultancy and Guidewire credentials, Alchemy brings deep expertise in the specialty insurance market, particularly in supporting complex and regulated environments, such as the London Market, the largest (re)insurance subscription market globally. This will further strengthen NTT DATA’s ability to serve niche and high-value segments across the global insurance landscape. A shared vision for insurance innovation This acquisition marks a significant milestone in NTT DATA’s strategy to lead the digital reinvention of the insurance sector - a market set to reach $230.7 billion in IT spend this year. Bui
INNIO Secures Largest Order in Company History with VoltaGrid Delivering Power Generation for One of the World’s Largest Data Centers21.10.2025 09:01:00 CEST | Press release
INNIO to supply 2.3 gigawatts (GW) of power infrastructure, comprising 92 power packs of 25 megawatts (MW) each. Partnership with VoltaGrid drives the expansion of AI data centers through fast, flexible, and sustainable energy solutions. Collaboration enables VoltaGrid to seamlessly combine its power pack units with its large-scale portable data center power made up of INNIO’s units. INNIO Group today announced the largest order by power delivery in its history: a groundbreaking 2.3 GW power infrastructure project featuring 92 power packs, each delivering 25 MW of output. The initiative with VoltaGrid strengthens INNIO’s position as a key energy solutions provider for the rapidly expanding U.S. data center sector. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251021503080/en/ INNIO Secures Largest Order in Company History (c) INNIO “This landmark order underscores the strength of INNIO’s technology and our ability to power
P.I. Works Celebrates 20 Years of Shaping the Telecom Industry21.10.2025 09:00:00 CEST | Press release
Empowering Operators Worldwide Through Innovation, Automation, and Solutions for Two Decades P.I. Works, the leading independent provider of AI-driven mobile network automation, optimization, and assurance solutions, proudly celebrates its 20th anniversary. This milestone marks two decades of driving telecom innovation and enabling mobile operators to deliver superior network performance, operational efficiency, and customer experience worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251021105217/en/ P.I. Works Celebrates 20 Year Anniversary From Network Optimization to AI-Driven Automation Founded in 2005, as mobile data traffic surged with the rise of 3G, P.I. Works introduced intelligent solutions to help operators plan, manage, and optimize their networks more efficiently. Over the years, the company pioneered Self-Organizing Network (SON) capabilities, establishing the foundation for large-scale automation and
The Coca-Cola Company and Gutsche Family Investments Agree to Sell Controlling Interest in Coca-Cola Beverages Africa to Coca-Cola HBC AG21.10.2025 08:00:00 CEST | Press release
The Coca-Cola Company and Gutsche Family Investments have agreed to sell a 75% controlling interest in Coca-Cola Beverages Africa Pty. Ltd. to Coca-Cola HBC AG, the companies announced today. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251020939952/en/ CCBA is the largest Coca-Cola bottler in Africa. It operates in 14 countries on the continent and accounts for about 40% of all Coca-Cola product volume sold across Africa. Coca-Cola HBC is one of the largest Coca-Cola bottlers in the world, with operations in 29 countries across Europe and Africa, including Nigeria and Egypt. Coca-Cola will sell 41.52% out of its 66.52% stake in CCBA to Coca-Cola HBC, and Coca-Cola HBC is acquiring 33.48% of CCBA that is held by GFI. In total, the transaction values 100% of CCBA at an equity value of US$3.4 billion. The transactions are targeted to close by the end of 2026. Coca-Cola and Coca-Cola HBC have also agreed to a separate option
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom