AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, today announced updated ADVC001 Phase 1 results. The data come from the TheraPb Phase 1 clinical trial (NCT05720130). ADVC001 is an investigational Lead-212 PSMA-targeted alpha therapy. The trial enrolled patients with mAPMR prostate cancer, formerly referred to as mCRPC. The company presented the findings at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.
The study tested escalating doses of 60–200 MBq ADVC001. Investigators administered the therapy at pre-specified intervals of every 6, 4, 2 or 1 week(s) for up to 6 cycles. As a result, the team could select the RP2D for both dose and schedule. Moreover, the Madrid update adds 12 months of safety and efficacy follow-up. It builds on the initial results reported at ESMO 2025.
Christopher Sweeney, MBBS, Director of the South Australian immunoGENomics Cancer Institute, commented on the findings.
“The longer follow-up data presented at ESMO underscore the potential for ADVC001 to deliver durable clinical benefit while maintaining a favorable safety profile,” said Christopher Sweeney, MBBS, Director of the South Australian immunoGENomics Cancer Institute. “These findings support further clinical development of this targeted alpha therapy to address the significant unmet needs of patients with metastatic prostate cancer.”
ADVC001 Delivers Strong Response Rates at the RP2D
The analysis of ADVC001 Phase 1 covers 22 patients across seven dose-schedule cohorts. Median follow-up reached 14.1 months at the 5 October 2026 data cut-off (open database). Overall, patients tolerated the treatment well. Most of them completed all 6 planned doses per protocol.
At the RP2D of 160 and 200 MBq, the PSA50 response rate reached 80%. In addition, these responses matched decreases in PSMA avid tumor volume on PSMA PET. Furthermore, blinded independent central review (BICR) confirmed a 100% ORR (5/5 confirmed responses) in patients with RECIST-measurable target lesions. Median rPFS reached 11.2 months at the RP2D as of data cut-off.
Principal Investigator Aaron R. Hansen, MBBS, of Princess Alexandra Hospital also weighed in on the updated data.
“The updated Phase 1 results from the TheraPb trial demonstrate a favorable safety and tolerability profile for ADVC001, with no new safety signals emerging after an additional 12 months of follow-up,” said Aaron R. Hansen, MBBS, Principal Investigator at Princess Alexandra Hospital. “Encouraging and sustained anti-tumor activity was observed at the RP2D. These findings support the continued Phase 2 evaluation of ADVC001, incorporating an optimized induction and maintenance dosing strategy aimed at enhancing the depth and durability of clinical benefit for patients with metastatic prostate cancer.”
Meanwhile, after ADVC001 Phase 1, Phase 2 enrollment is ongoing. The study evaluates the RP2D of 160 MBq and 200 MBq in mAPMS and mAPMR prostate cancer. It also applies a novel induction, maintenance and response-adapted ADVC001 dosing strategy. This approach allows up to 12 doses. Its aim is to enhance and prolong clinical benefit.
Anna Karmann, MD PhD, Chief Medical Officer at AdvanCell, thanked everyone involved in the study.
“We thank the patients and their families, investigators, site staff, and collaborators for their commitment, partnership and contributions to this study,” said Anna Karmann, MD PhD, Chief Medical Officer, AdvanCell. “These data support the continued development of ADVC001 as a potential treatment option for men with prostate cancer, and we look forward to further evaluating its therapeutic potential in ongoing and future studies.”
Overall, ADVC001 continues to show a favorable safety profile and signs of sustained anti-tumor activity. The updated findings reinforce its promising therapeutic profile. They also support further investigation and dosage optimization.
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News Source: Businesswire.com
