Who is sponsoring NCT04506567?

NCT04506567 is sponsored by Weill Medical College of Cornell University.

What condition does NCT04506567 study?

NCT04506567 studies Prostate Cancer.

What drugs are being tested in NCT04506567?

Interventions: Fractionated dose of 225Ac-J591, 68Ga-PSMA-HBED-CC injection, Multiple single doses of 225Ac-J591.

What is the status of NCT04506567?

NCT04506567 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2026-02-12 · How we verify

Phase I/II Dose-escalation Study of Fractionated and Multiple Dose 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer

NCT04506567 Phase 1/Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Weill Medical College of Cornell University
Phase	Phase 1/Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	60
Start date	2020-08-18
Completion	2026-06

Conditions

Prostate Cancer

Interventions

Fractionated dose of 225Ac-J591
68Ga-PSMA-HBED-CC injection
Multiple single doses of 225Ac-J591

Primary outcomes

Number of participants with dose limiting toxicity (DLT) — Collected from Day 1 through 6 months
DLTs will be measured by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Cumulative maximum tolerated dose (MTD) — Collected from Day 1 through 6 months
The dose that produces an "acceptable" level of toxicity or that, if exceeded, would put subjects at "unacceptable" risk for toxicity. MTD is defined as the dose level at which no more than two patients out of six experienced dose-limiting toxicity (DLT).
Recommended phase II dose (RP2D) of 225Ac-J591 in fractionated dose and multiple dose regimens both pre- and post-treatment with 177Lu-PSMA-RL — Collected from Day 1 through 6 months
Proportion of participants with PSMA-positive tumors with >50% PSA decline following 225Ac-J591 in two regimens both pre- and post- treatment with 177Lu-PSMA-RL — Collected from Day 1 through 6 months
Proportion of participants achieving greater than 50% PSA decline (relative to baseline/pre-treatment PSA). Response may occur at any time following treatment initiation and prior to going off study or initiation of new therapy.

Countries

United States