Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC

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

• Prostate Cancer

Interventions

DRUG

Multiple Dose of 225Ac-J591 at 45 KBq/kg

Multiple dose of 45 KBq/kg

DRUG

Multiple Dose of 225Ac-J591 at 55 KBq/kg

Multiple dose of 55 KBq/kg in dose-escalation regimen

DRUG

Multiple Dose of 225Ac-J591 at 65 KBq/kg

Multiple dose of 65 KBq/kg in dose-escalation regimen

DRUG

Fractionated Dose of 225Ac-J591 at 45 KBq/kg

Fractionated dose of 45 KBq/kg in dose-escalation regimen

DRUG

Fractionated Dose of 225Ac-J591 at 55 KBq/kg

Fractionated dose of 55 KBq/kg in dose-escalation regimen

DRUG

Fractionated Dose of 225Ac-J591 at 60 KBq/kg

Fractionated dose of 60 KBq/kg in dose-escalation and dose-expansion regimens

DRUG

Fractionated Dose of 225Ac-J591 at 65 KBq/kg

Fractionated dose of 65 KBq/kg in dose-escalation regimen

DRUG

Fractionated Dose of 225Ac-J591 at 45 KBq/kg (Prior 177Lu-PSMA-RL)

Fractionated dose of 45 KBq/kg for cohort of participants previously treated with 177Lu-PSMA-RL

DRUG

Fractionated Dose of 225Ac-J591 at 50 KBq/kg (Prior 177Lu-PSMA-RL)

Fractionated dose of 50 KBq/kg for cohort of participants previously treated with 177Lu-PSMA-RL

DIAGNOSTIC_TEST

68Ga-PSMA-HBED-CC injection

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

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

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations