NCT04886986

Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Male
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I dose-escalation study of 225Ac-J591 administered together with 177Lu-PSMA small molecule. Both drugs are designed to deliver radiation to prostate cancer cells; they are known as radionuclide conjugates (radiation linked to antibodies/molecules that recognize prostate cancer cells). This phase of the study (phase I) will determine the highest dose of the study intervention that can be safely given.

Detailed description

This clinical trial is for men with progressive metastatic castration-resistant prostate cancer (mCRPC). The two primary objectives of this trial are to determine the highest dose of 225Ac-J591 and 177Lu-PSMA-small molecule that can be administered together (also known as maximum tolerated dose) with the recommended phase II dose and to determine the effectiveness of the drug combination. The two drugs will be co-administered every 8 weeks, for 2 cycles.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	225Ac-J591	30 - 40 KBq/kg (dose-escalation) every 8 weeks, for up to 2 cycles. Administered together with 177Lu-PSMA-617. Intravenous administration.
DRUG	177Lu-PSMA-617	6.8 - 7.4 GBq received every 8 weeks, for up to 2 cycles. Administered together with 225Ac-J591. Intravenous administration.
DRUG	68Ga-PSMA-11	\[185 ±74 MBq or 5 ±2 mCi\] intravenous during screening, 12 weeks, 24 weeks. Imaging agent for PSMA PET/CT.
DRUG	177Lu-PSMA-I&T	6.8 GBq received every 8 weeks, up to 2 cycles. Administered together with 225Ac-J591. Intravenous administration.

Timeline

• Start date: 2021-06-30
• Primary completion: 2027-12-01
• Completion: 2029-12-01
• First posted: 2021-05-14
• Last updated: 2026-03-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study