AdvanCell reports updated Phase 1 results for ADVC001, showing an 80% PSA50 response rate and 11.2-month median radiographic progression-free survival in prostate cancer.
Written By: Kalyani Boharapi,
M.Pharm (RA)
Reviewed By: Pharmacally Editorial Team
AdvanCell, a radiopharmaceutical company headquartered in Andover, Massachusetts, US, develops Lead-212-based targeted alpha therapies for cancer. The company has reported updated Phase 1 results for ADVC001, an investigational Lead-212 (²¹²Pb)-based prostate-specific membrane antigen (PSMA)-targeted alpha therapy for metastatic prostate cancer, showing encouraging antitumour activity and no new safety signals in patients with metastatic androgen pathway modulation-resistant (mAPMR) disease. At the selected recommended Phase 2 doses (RP2Ds) of 160 and 200 MBq, ADVC001 achieved an 80% prostate-specific antigen (PSA50) response rate and a 100% objective response rate among patients with RECIST-measurable target lesions.
The updated findings from the TheraPb trial (NCT05720130) were presented at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain. The analysis included a median follow-up of 14.1 months, with an additional 12 months of safety and efficacy follow-up compared with the results reported at ESMO 2025. Median radiographic progression-free survival (rPFS) at the selected RP2Ds was 11.2 months as of the October 5, 2026, data cutoff.
Phase 1 Results Show Antitumor Activity at Selected Doses
The Phase 1 analysis included 22 patients enrolled across seven dose-schedule cohorts. Patients received ADVC001 at activities ranging from 60 to 200 MBq, administered at intervals of one, two, four or six weeks, for up to six treatment cycles.
At the selected RP2Ds of 160 and 200 MBq, 80% of patients achieved a PSA50 response, defined as a reduction in PSA levels of at least 50% from baseline. These biochemical responses corresponded with decreases in PSMA-avid tumour volume on PSMA positron emission tomography (PET) imaging.
Among patients with RECIST-measurable target lesions, five of five achieved confirmed objective responses, according to blinded independent central review (BICR). Although this result represents a notable early efficacy signal, the response-evaluable population was small and should not be interpreted as evidence of a similarly high response rate across all patients with metastatic prostate cancer.
The median rPFS of 11.2 months provides an additional measure of disease-control activity. However, the reported results do not establish an overall survival benefit or demonstrate superiority over existing treatments. Further evaluation in larger patient populations is needed to determine the consistency and clinical significance of these findings.
Extended Follow-Up Reports No New Safety Signals
AdvanCell reported that ADVC001 maintained a favourable safety and tolerability profile, with no new safety signals emerging during the additional follow-up. Most patients had completed all six planned treatment doses according to the study protocol.
The absence of new safety signals is encouraging as development progresses, but it does not establish that the treatment is free from clinically significant toxicity. The company’s announcement does not provide a detailed breakdown of adverse events or updated event-specific incidence rates, limiting an independent assessment of the full safety profile from this update alone.
Lead-212-Based Therapy Targets PSMA-Expressing Tumours
ADVC001 is a proprietary, patented radiopharmaceutical designed to target PSMA, a protein expressed in many prostate cancer cells, and deliver radiation to tumour tissue. Its Lead-212 payload is an alpha-emitting radionuclide with a reported half-life of approximately 10.6 hours.
The approach aims to deliver radiation at the cellular level while limiting exposure to healthy tissues. Whether this targeting strategy translates into a favourable overall benefit-risk profile will depend on the efficacy and safety results observed across further clinical development.
Phase 2 Expansion to Evaluate Dosing Strategies
AdvanCell is continuing Phase 2 expansion of the TheraPb trial to evaluate the selected 160 and 200 MBq dose levels in patients with mAPMR and metastatic androgen pathway modulation-sensitive (mAPMS) prostate cancer.
The programme incorporates induction, maintenance and response-adapted dosing, with treatment planned for up to 12 doses. This strategy is intended to optimise treatment intensity and duration according to patient response. Its ability to improve the depth or durability of clinical benefit remains to be established.
The updated Phase 1 findings support continued investigation of ADVC001, particularly given the observed PSA responses, confirmed tumour responses and reported rPFS. Nevertheless, the small study population and limited response-evaluable subgroup make confirmation in the ongoing Phase 2 programme essential before the treatment’s clinical role can be determined.
Reference
AdvanCell. AdvanCell Presents Updated Phase 1 Results on ADVC001 at ESMO 2026 with Encouraging Long-term Data. October 23, 2026.
Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb – Phase I/II Study), ClinicalTrials.gov ID NCT05720130
About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.