NCT05413850

Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection

An Open-label, Multicentre, Integrated Phase 1 & 2 Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Anti-tumour Activity of Lutetium (177Lu) rhPSMA-10.1 Injection in Men With Metastatic Castrate-resistant Prostate Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Blue Earth Therapeutics Ltd · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.

Detailed description

This is an interventional, open-label, integrated Phase 1 \& 2 study to assess the safety, tolerability, radiation dosing regimen and anti-tumour activity of Lutetium (177Lu) rhPSMA-10.1 (IMP) in men with metastatic castrate-resistant prostate cancer (mCRPC). The study will consist of 2 parts: a non-randomised Phase 1 part, with safety, dose-finding, and dosimetry components, and a randomised Phase 2 part, with efficacy and safety assessments, and testing dosing regimens selected following analysis of the safety and dosimetry data in Phase 1. Both phases will include subjects with prostate-specific membrane antigen (PSMA)-positive mCRPC, which has progressed following prior therapy. Phase 1 will include a post-chemotherapy mCRPC cohort of subjects who have experienced disease progression on or after at least 1 novel androgen axis drug (NAAD) (e.g. abiraterone, enzalutamide) and at least 1 course (but no more than 2 courses) of taxane-based chemotherapy. Phase 2 will include subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide, apalutamide, darolutamide) but have not received previous taxane-based chemotherapy for the treatment of mCRPC.

Conditions

• Prostate Cancer
• Metastatic Castration-resistant Prostate Cancer
• mCRPC
• Urogenital Neoplasms
• Prostatic Neoplasms
• Prostatic Diseases

Interventions

Type	Name	Description
DRUG	Lutetium (177Lu) rhPSMA-10.1 Injection	Therapeutic cycles of 177Lu-rhPSMA-10.1
DIAGNOSTIC_TEST	18F-rhPSMA-7.3 injection (in phase 1 only)	18F-rhPSMA-7.3 (in phase 1 only) at an administered activity of 296 MBq (8 mCi) for PET/CT scan to ascertain whether the subject has PSMA-positive disease.

Timeline

• Start date: 2022-07-20
• Primary completion: 2026-08-27
• Completion: 2028-03-31
• First posted: 2022-06-10
• Last updated: 2026-04-13

Locations

23 sites across 5 countries: United States, Belgium, Germany, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study