Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04506567

Run by

Weill Medical College of Cornell University

People needed

60

Starts

2020-08-18

Expected to finish

2026-06-01

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older, up to 99. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of prostate
• Documented progressive metastatic CRPC based on Prostate Cancer Working
• Group 3 (PCWG3) criteria, which includes at least one of the following criteria:
• PSA progression
• Objective radiographic progression in soft tissue
• New bone lesions
• Have serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy
• Have previously been treated with at least one of the following in any disease state:
• Androgen receptor signaling inhibitor (such as enzalutamide)
• CYP 17 inhibitor (such as abiraterone acetate)
• Have previously received taxane chemotherapy (in any disease state), been determined to be ineligible for taxane chemotherapy by their physician, or refused taxane chemotherapy.
• Age > 18 years
• Patients must have normal organ and marrow function as defined below:
• Absolute neutrophil count >2,000 cells/mm3
• Hemoglobin ≥9 g/dL
• Platelet count >150,000 x 109/uL
• Serum creatinine <1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault
• Serum total bilirubin <1.5 x ULN (unless due to Gilbert's Syndrome in which case direct bilirubin must be normal)
• Serum AST and ALT <3 x ULN in absence of liver metastases; < 5x ULN if due to liver metastases (in both circumstances bilirubin must meet entry criteria)
• ECOG performance status of 0-2
• Ability to understand and the willingness to sign a written informed consent document
• For patients enrolled in the post-177Lu-PSMA-RL cohorts, must have previously received either 177Lu-PSMA-617 or 177Lu-PSMA-I\&T

You may not qualify if…

• Implantation of investigational medical device ≤4 weeks of Treatment Visit 1 (Day 1) or current enrollment in oncologic investigational drug or device study
• Use of investigational drugs ≤4 weeks or <5 half-lives of Cycle 1, Day 1 or current enrollment in investigational oncology drug or device study
• Prior systemic beta-emitting bone-seeking radioisotopes (e.g. samarium-153, strontium-89)
• For patients enrolled in the post-177Lu-PSMA-RL cohorts: prior radium-223
• Untreated hydronephrosis
• Known active brain metastases or leptomeningeal disease
• History of deep vein thrombosis and/or pulmonary embolus within 1 month of C1D1
• Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
• Radiation therapy for treatment of PC ≤4 weeks of Day 1 Cycle 1
• Chemotherapy for treatment of PC ≤4 weeks of Day 1 Cycle 1
• Patients on stable dose of bisphosphonates or denosumab, which have been started no less than 4 weeks prior to treatment start, may continue on this medication, however patients are not allowed to initiate bisphosphonate/Denosumab therapy during the DLT-assessment period of the study
• Having partners of childbearing potential and not willing to use a method of birth control deemed acceptable by the principle investigator and chairperson during the study and for 1 month after last study drug administration
• Currently active other malignancy other than non-melanoma skin cancer. Patients are considered not to have "currently active" malignancy if they have completed any necessary therapy and are considered by their physician to be at less than 30% risk of relapse
• Known history of myelodysplastic syndrome
• Bone scan with confluent lesions and lack of urinary tracer consistent with a "superscan" as determined by the investigator

Where it is running

• Brooklyn Methodist Hospital - New York Presbyterian — Brooklyn, New York, United States
• Weill Cornell Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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