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Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC

NCT04506567 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-17

No results posted yet for this study

Summary

The purpose of the initial (phase I) portion of this study is to find a dose level and administration schedule of the study drug, 225Ac-J591, that can be given without severe side effects. The purpose of the second (phase II) portion of the study is to determine the proportion of those with PSMA-positive tumors with \>50% PSA decline following 225Ac-J591 treatment in two regimens.

Conditions

Interventions

DRUG

Fractionated dose of 225Ac-J591

Single cycle of fractionated dose of 225Ac-J591

DIAGNOSTIC_TEST

68Ga-PSMA-HBED-CC injection

68Ga-PSMA-HBED-CC PET/CT before and after treatment

DRUG

Multiple single doses of 225Ac-J591

Single dose of 225Ac-J591 every 6 weeks up to 4 cycles

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Joseph R Osborne, MD · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2025-06-01
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04506567 on ClinicalTrials.gov