TheranosticTrials.org

Clinical Trial · NCT03276572

Phase I Trial of 225Ac-J591 in Patients With mCRPC

Overview

This is an open-label, single-center Phase I dose escalation study designed to determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) of 225Ac-J591 in a single dose regimen.

Sponsor

Weill Medical College of Cornell University

Phase

Phase 1

Contacts

Scott Tagawa, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03276572

Drug / Compound

PSMA-HBED-CC

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

J591

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Antibodies

Eligibility

Inclusion

  • Have previously received taxane chemotherapy, been determined to be ineligible for taxane chemotherapy by their physician, or refused taxane chemotherapy.
  • Patients must have normal organ and marrow function as defined below:
  • Have previously been treated with at least one of the following:
  • 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)
  • Absolute neutrophil count \>2,000 cells/mm3
  • PSA progression
  • CYP 17 inhibitor (such as abiraterone acetate)
  • Serum total bilirubin \<1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal
  • ECOG performance status of 0-2
  • Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria:
  • Hemoglobin ≥9 g/dL
  • Androgen receptor signaling inhibitor (such as enzalutamide)
  • New bone lesions
  • Serum creatinine \<1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault
  • Have serum testosterone \< 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist/antagonist) if they have not undergone bilateral orchiectomy.
  • Platelet count \>150,000 x 109/microliter
  • Objective radiographic progression in soft tissue
  • Histologically or cytologically confirmed adenocarcinoma of prostate

Exclusion

  • History of deep vein thrombosis and/or pulmonary embolus within 1 month of C1D1
  • Radiation therapy for treatment of PC ≤4 weeks of Day 1 Cycle 1
  • Known history of known myelodysplastic syndrome
  • 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
  • Implantation of investigational medical device ≤4 weeks of Cycle 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
  • 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.
  • 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
  • Prior systemic beta-emitting bone-seeking radioisotopes
  • Known active brain metastases or leptomeningeal disease