177Lu-HTK03170 in mCRPC With PSMA Positive Disease

Summary

This study will determine the safe initial injected activity of the radioligand therapy 177Lu-HTK03170 for the measurement of dosimetry and initiation of treatment in subjects with PSMA-positive, metastatic castrate resistant prostate cancer, (mCRPC). Subjects will receive treatment which will be escalated between cycles and personalized based on dosimetry calculations and imaging. In addition, antitumour activity will be measured by radiographic response, and further assessments of the treatment will be measured by CT imaging, ctDNA/ctRNA, PSA, PSMA PET/CT, and quality of life questionnaires. Subjects will be followed for 2 years or until they have progression and are switched to another systemic treatment.

Timeline

Start

2024-01-01

Primary completion

2026-12-01

Completion

2027-05-01

Publications

• Harsini S, Soleimani M, Wilson D, Uribe C, Saprunoff H, Bloise I, Benard F. A Phase I/II Study of [177Lu]Lu-HTK03170 with Personalized Dosimetry in Patients with Metastatic Castration-Resistant Prostate Cancer: Clinical Trial Protocol. J Nucl Med. 2025 Jul 1;66(7):1061-1067. doi: 10.2967/jnumed.124.269064.

Drugs

Indications