TheranosticTrials.org

Clinical Trial · NCT03042468

Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC

Overview

The purpose of this study is to find the highest dose level of the study drug, 177Lu-PSMA-617 that can be given without severe side effects for advanced prostate cancer.

Sponsor

Weill Medical College of Cornell University

Phase

Phase 1/2

Contacts

Scott Tagawa, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03042468

Drug / Compound

PSMA-HBED-CC

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

PSMA-617

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Objective radiographic progression in soft tissue
  • CYP 17 inhibitor (such as abiraterone acetate)
  • Patients must have normal organ and marrow function as defined below:
  • Histologically or cytologically confirmed adenocarcinoma of prostate
  • Hemoglobin ≥9 g/dL (independent of transfusion and/or growth factors within 1 month prior to registration)
  • Serum AST and ALT \<1.5 x ULN
  • Have previously been treated with at least one of the following:
  • 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.
  • Serum creatinine \<1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault
  • ECOG performance status of 0-2
  • Absolute neutrophil count \>2,000 cells/mm3
  • PSA progression
  • Platelet count \>150,000 x 109/uL (independent of transfusion and/or growth factors within 3 months prior to randomization)
  • Serum total bilirubin \<1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal
  • Have previously received taxane chemotherapy, been determined to be ineligible for taxane chemotherapy by their physician, or refused taxane chemotherapy.
  • New bone lesions
  • Androgen receptor signaling inhibitor (such as enzalutamide)
  • Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria:

Exclusion

  • 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
  • Brain metastases or leptomeningeal disease
  • Prior systemic beta-emitting bone-seeking radioisotopes
  • 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.
  • Use of investigational drugs or implantation of investigational medical device ≤4 weeks of Cycle 1, Day 1 or current enrollment in investigational drug or device study
  • Radiation therapy for treatment of PCa ≤4 weeks of Day 1 Cycle 1
  • History of deep vein thrombosis and/or pulmonary embolus within 1 month of study entry
  • 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