NCT07214961

Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biodistribution and Antitumour Activity of the Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: ARTBIO Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1 study will evaluate the safety, tolerability, and preliminary effectiveness of AB001, an alpha-emitting radioligand targeting prostate-specific membrane antigen (PSMA), in patients with advanced prostate cancer who are either 177Lu-PSMA naïve or experienced. The study includes dose escalation to identify a recommended dose and dose expansion to further assess safety and anti-tumour activity. Primary objectives are to characterize the safety profile and determine the optimal dose and schedule for future studies

Conditions

• Prostate Cancer (CRPC)
• Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
DRUG	AB001	Pb-212 PSMA targeted alpha radioligand therapy

Timeline

• Start date: 2025-11-03
• Primary completion: 2027-11-03
• Completion: 2028-11-03
• First posted: 2025-10-09
• Last updated: 2026-04-07

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study