212 Pb-ADVC001 / AdvanCell Isotopes - LARVOL DELTA

AdvanCell Initiates Phase 2 Expansion Trial of ADVC001, a Novel Targeted Alpha Therapy for Prostate Cancer (Businesswire) - "The Phase 2 expansion will evaluate 160 MBq and 200 MBq doses of ADVC001 using a randomized, multi-dose-response design and adaptive dosing strategies to optimize clinical outcomes across three indications: metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC)....Enrollment for the TheraPb Phase 2 expansion is expected to commence initially at clinical sites in Australia, with planned expansion to sites in the United States in 2026....AdvanCell plans to present additional details on the TheraPb Phase 2 expansion trial design at a major oncology conference in the first half of 2026."

Clinical protocol • Trial status • Castration-Resistant Prostate Cancer • Hormone Sensitive Prostate Cancer

AdvanCell to Present Promising Clinical Trial Results of ADVC001, a Novel Lead-212-based PSMA-targeted Alpha Therapy for Prostate Cancer, at ESMO 2025 (Businesswire) - "The presentation will feature promising results from the Phase 1b dose escalation of the Phase 1/2 TheraPb study, evaluating ADVC001, a Lead-212-based PSMA-targeted alpha therapy, in metastatic castration-resistant prostate cancer (mCRPC)....The abstract presents a favorable safety profile for 212Pb-ADVC001 and promising anti-tumor activity, underscoring the potential of 212Pb-ADVC001 to enhance therapeutic options for patients with metastatic prostate cancer."

P1 data • Castration-Resistant Prostate Cancer

AdvanCell’s 212Pb-ADVC001 demonstrates encouraging safety and compelling anti-tumor activity in Phase 1b in prostate cancer (GlobeNewswire) - "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; 80% PSA50 biochemical response at therapeutic doses ≥ 160 MBq"

P1 data • Castration-Resistant Prostate Cancer

Deep Longitudinal Immunophenotyping of Immune Cells in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with 212 Pb-based PSMA-Targeted Alpha Therapy (EANM 2025) - P1/2 | "To measure immunogenic response to TAT we have designed and validated a full-spectrum flow cytometry panel for the detection of immune cell populations in blood samples from patients with metastatic castration-resistant prostate cancer (mCRPC) who received the PSMA-TAT, 212 Pb-ADVC001, as part of the Phase I/II TheraPb study (NCT05720130)...The panel has potential to provide valuable insights into the adaptive immune response in subjects treated with TAT. The presented approach may also be beneficial in predicting response and optimising dosing schedules, enabling biomarker driven adaptive dosing regimens."

Clinical • Immune cell • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD4 • CD8

Results from the phase Ib dose escalation of 212Pb-ADVC001 in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC): The theraPb trial (ESMO 2025) - P1/2 | "Table: 2388P Exposure and PSA responses in the 120 MBq, 160 MBq and 200 MBq Cohorts at cut-off Parameter ≥120 MBq Cohorts n = 12 pts Previous systemic therapy regimens (excluding ADT and 1st generation AR antagonists) 1 or 2: 6 pts (50%) ≥3: 6 pts (50%) 212 Pb-ADVC001 cycles administered, by cohort *treatment complete, 6 cycles/pt ‡treatment ongoing, up to 6 cycles/pt Cohort 2a, 120 MBq Q4W: 18 (3 pts)* Cohort 3a, 160 MBq Q4W: 18 (3 pts)* Cohort 4a, 200 MBq Q4W: 10 (3 pts)‡ Cohort 3b, 160 MBq Q2W: 12 (3 pts)‡ Premature treatment discontinuation or dose modification 0 pts Best PSA response (decrease from baseline) n pts (%) PSA ≥50% 9 (75%) PSA ≥80% 5 (42%) PSA ≥90% 3 (25%) Conclusions 212 Pb-ADVC001 has a favourable safety profile with promising anti-tumour activity at doses of 120–200 MBq. Updated safety and efficacy data, including Q2W cohorts, will be presented at the meeting and will inform the RP2D for the planned phase 2a."

Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Radiation Safety with 212 Pb-Based Therapeutics from Clinical Experience with 212 Pb-ADVC001 (TheraPb): Dose to Staff and Members of the Public (EANM 2025) - No abstract available

Clinical

Adaptive Design and Dose Optimization in a Phase Ib/IIa Dose Escalation and Expansion Study of 212 Pb-ADVC001 in Metastatic Castration-Resistant Prostate Cancer (mCRPC): TheraPb - Phase I/II Study (EANM 2025) - No abstract available

Metastases • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Preclinical Evaluation of [212Pb]Pb-ADVC001: A Prostate-Specific Membrane Antigen-Targeted α-Therapy for Prostate Cancer. (PubMed, J Nucl Med) - "All treatments were well tolerated. The preclinical results support the clinical development of 212Pb-ADVC001 as a targeted α-therapy for the treatment of patients with PC."

Journal • Preclinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

Uncovering the mechanisms of action of 177Lu- and 212Pb- based PSMA radioligand therapies (AACR 2025) - "Introduction: 177Lu-PSMA-617 is the first FDA-approved targeted radioligand therapy (RLT), and in clinical trials, significantly prolonged survival and improved quality of life in patients with metastatic castration resistant prostate cancer (mCRPC). Comparison studies of 177Lu- and 212Pb-PSMA treatment on PC cells showed a higher efficacy of 212Pb-PSMA in vitro and in vivo supporting the clinical application of 212Pb-PSMA for mCRPC. Mechanistic studies furthered the understanding of PC radiobiology and cellular responses to beta- and alpha-RLT with the identification of a cell cycle arrest in PC specifically induced by 212Pb-PSMA."

Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Preclinical evaluation of a novel 212Pb-based, PSMA-targeted radioligand, 212Pb-ADVC001, for prostate cancer treatment (AACR 2025) - P1/2 | "Preclinical data demonstrated the potential of 212Pb-ADVC001 for the treatment of patients with PSMA+ prostate cancer. Transcriptomic and proteomic analyses indicate multiple mechanisms of action collectively resulting in effective cancer therapy."

Preclinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase Ib/IIa dose escalation and expansion study of [212Pb]Pb-ADVC001 in metastatic castration-resistant prostate cancer: TheraPb–phase I/II study. (ASCO-GU 2025) - P1/2 | "The radioligand therapy 177Lu-PSMA-617, which uses a beta-emitting isotope linked to a PSMA-targeting small molecule, has shown a median survival advantage in mCRPC of four months, underpinning the critical need for more effective treatments. If data from Phase 1b demonstrates multiple dosing regimens are reasonably equivalent in terms of safety, tolerability and anti-tumor activity, the Phase 2a expansion study may include adaptive randomization to identify an optimized dose and schedule. The trial is currently enrolling at two clinical sites in Australia."

Metastases • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Novel 212Pb-PSMA Targeted Alpha Therapy for the Treatment of Metastatic Castration-Resistant Prostate Cancer (EANM 2024) - P1/2 | "Preclinical pharmacokinetic, biodistribution and efficacy data demonstrate the potential of 212Pb-PSMA for the treatment of mCRPC. In vivo, improved efficacy with more durable responses is observed with 212Pb-ADVC001 compared to 177Lu-PSMA I&T suggesting that 212Pb-ADVC001 has the potential to not only limit toxicities associated with conventional PSMA-targeted radiopharmaceuticals, but also to improve treatment of mCRPC."

Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

212Pb SPECT/CT Clinical Imaging for Routine Biodistribution and Dosimetry of Targeted Alpha Therapy (EANM 2024) - "We have developed a SPECT/CT acquisition protocol for routine biodistribution and dosimetry imaging in patients with metastatic castration resistant prostate cancer (mCRPC) following the administration of a novel PSMA-targeted-therapy, [212Pb] Pb-ADVC001... 212Pb SPECT/CT imaging allows confirmation of TAT biodistribution and permits TAT dose estimates, assuming no progeny redistribution."

Clinical • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Castration Resistant Prostate Cancer (TheraPb - Phase I/II Study). (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: AdvanCell Isotopes Pty Limited | N=18 ➔ 100 | Trial completion date: Jun 2024 ➔ Dec 2029 | Trial primary completion date: Jun 2024 ➔ Dec 2027

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Development of a Novel 212Pb-based Targeted Alpha Therapy for metastatic Castration-Resistant Prostate Cancer (SNMMI 2024) - P1/2 | "212Pb-ADVC001 shows great promise as a novel TAT for mCRPC. 212Pb SPECT/CT imaging provides post-infusion TAT biodistribution and can be used for high quality dosimetry analysis enabling optimal 212Pb-TAT development and delivery. Poster Award Candidate: Poster Award Candidate"

Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

AdvanCell Announces First Patient Dosed in Phase I/II TheraPb Clinical Trial of 212Pb-ADVC001 in Metastatic Prostate Cancer (Businesswire) - "AdvanCell...announced the first patient was treated with 212Pb-ADVC001, a Targeted Alpha Therapy in development for the treatment of PSMA-positive metastatic Castration-Resistant Prostate Cancer (mCRPC)....The Phase I/II trial of 212Pb-ADVC001 is a multicentre, open-label study evaluating safety and efficacy in patients with PSMA-positive mCRPC."

Trial status • Prostate Cancer

An early phase clinical trial to measure the safe dose of a new alpha-radiopharmaceutical for the treatment of advanced prostate cancer (ANZCTR) - P1/2 | N=18 | Recruiting | Sponsor: AdvanCell Isotopes Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Dose Escalation and Efficacy Study of 212Pb-ADVC001 in Patients With Metastatic Castration Resistant Prostate Cancer. (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: AdvanCell Isotopes Pty Limited | Trial completion date: Mar 2024 ➔ Jun 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Dose Escalation and Efficacy Study of 212Pb-ADVC001 in Patients With Metastatic Castration Resistant Prostate Cancer. (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: AdvanCell Isotopes Pty Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Dose Escalation and Efficacy Study of 212Pb-ADVC001 in Patients With Metastatic Castration Resistant Prostate Cancer. (clinicaltrials.gov) - P1/2 | N=18 | Not yet recruiting | Sponsor: AdvanCell Isotopes Pty Limited

Metastases • New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

AdvanCell Closes A$18M Series B Funding Led by Morningside (Businesswire) - "AdvanCell...announced today the closing of an A$18 million Series B financing round led by Morningside....Series B financing will accelerate growth and advance lead clinical program 212Pb-ADVC001 a best-in-class treatment for metastatic prostate cancer, expand manufacturing platform footprint and progress internal and partnership programs."

Financing • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor