Dosing begins in trial of alpha radioligand therapy for mCRPC

The first patients have been dosed in the phase 1 ARTISAN trial (NCT07214961), evaluating the alpha radioligand therapy (ART) AB001 for metastatic castration-resistant prostate cancer (mCRPC), ARTBIO announced in a news release.¹

According to the company, AB001 is “an ART consisting of a prostate-specific membrane antigen (PSMA)-targeted small molecule radiolabeled with ²¹²Pb.”

"AB001 PSMA-targeted radioligand therapy has the potential to reshape the treatment landscape for patients with metastatic castration-resistant prostate cancer who urgently need additional pathways forward,” noted principal investigator Brandon Mancini, MD, MBA, FACRO, Medical Director of BAMF Health, in the news release.¹

The ARTISAN trial includes both ¹⁷⁷Lu-PSMA naïve and ¹⁷⁷Lu-PSMA experienced cohorts, which will each undergo a dose escalation phase to identify a recommended dose level and treatment schedule as well as a dose expansion phase to further assess the safety and anti-tumor activity of AB001. In the dose escalation phase, AB001 will be administered at a starting dose of 100 MBq Pb212.

In total, the open-label trial plans to enroll approximately 80 patients across multiple clinical trial sites in the US.² ARTBIO has plans to expand enrollment to sites outside of the US in the second half of 2026.

To be eligible for inclusion, patients need to have an ECOG Performance Score of 0 to 2 and adequate bone marrow, renal, and hepatic function. Participants must also have had prior treatment with at least 1 novel androgen receptor pathway inhibitor, prior orchiectomy and/or ongoing androgen deprivation therapy, and prior treatment with at least 1 taxane regimen or considered appropriate to delay taxane therapy.

The primary outcome measure for the study is to determine the safety and tolerability profile of AB001, as assessed through the incidence and severity of treatment-emergent adverse events. In the dose escalation portion, the primary end points are to determine the recommended dose level and schedule of AB001 for dose expansion. The study will also assess the biodistribution, body clearance, and pharmacokinetics of AB001.

"The ARTBIO team is excited to continue to advance AB001 as our lead clinical asset for patients with and without prior Lu177-PSMA targeted therapy," said Margaret Yu, Chief Medical Officer of ARTBIO, in the news release.¹ "We are proud to collaborate with team members at BAMF Health and United Theranostics and are especially grateful to the patients who have enrolled in this study."

Primary completion of the ARTISAN trial is expected in November 2027.

REFERENCES

1. ARTBIO announces dosing of two cohorts with AB001 in ARTISAN, a phase 1 alpha radioligand therapy clinical trial for metastatic castration resistant prostate cancer. News release. ARTBIO. January 12, 2026. Accessed January 12, 2026. https://www.prnewswire.com/news-releases/artbio-announces-dosing-of-two-cohorts-with-ab001-in-artisan-a-phase-1-alpha-radioligand-therapy-clinical-trial-for-metastatic-castration-resistant-prostate-cancer-302657972.html

2. Study of alpha radioligand therapy AB001 in patients with metastatic castration resistant prostate cancer (mCRPC) (ARTISAN). ClinicalTrials.gov. Last updated December 22, 2025. Accessed January 12, 2026. https://www.clinicaltrials.gov/study/NCT07214961