TheranosticTrials.org

Clinical Trial · NCT02552394

J591 in Patients With Advanced Prostate Cancer and Unfavorable Circulating Tumor Cell Counts

Overview

This clinical trial is for men with advanced prostate cancer that may have spread to other parts of the body. Currently, once prostate cancer cells have spread from the prostate to other organs it is not treatable by surgery. The purpose of this study is to treat patients with an experimental antibody (i.e. that has not been FDA approved) called J591 that attaches itself to a special protein on cancer cells called PSMA to try to eliminate these cancer cells (called circulating tumor cells) from the circulation. In the initial phase of the study, 6 participants will receive the experimental J591 treatment. Routine blood tests, research blood tests, physical exam will be performed at each visit. Participants will also be asked to complete a questionnaire about how they are feeling. Participants will have a radiographic scan every 3 months to check the status of their disease. Participants who tolerate the treatment well may be re-treated at the same level every 3 months, and may continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

Sponsor

Weill Medical College of Cornell University

Phase

Phase 1

Contacts

Scott Tagawa, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02552394

Drug / Compound

huJ591

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

Eligibility

Inclusion

  • Bilirubin (total) \> 1.5x ULN; subjects with known Gilbert's syndrome are eligible if direct bilirubin is within normal limits
  • Subjects who have received traditional anti-androgen (i.e. bicalutamide, nilutamide, flutamide) therapy with a resulting PSA decline must continue anti-androgen therapy or demonstrate progression following discontinuation of anti-androgen therapy (not necessary for those who never responded to anti-androgen addition).
  • Life expectancy \< 6 months
  • PSA progression defined by an absolute value 2 ng/mL with an increase in PSA determined by two separate measurements taken at least one week apart and confirmed by a third, and if necessary, a fourth measurement. If the third measurement is not greater than the second measurement, then a fourth measurement must be taken; the fourth measurement must be greater than the second measurement for the subject to be eligible for enrollment in the study. Furthermore, the confirmatory PSA measurement (i.e., the third or, if applicable, fourth PSA measurement) must be 2 ng/mL and ≥ 25% above the previous nadir.
  • Subject must have progressive metastatic prostate cancer as defined as at least any one of the following:
  • Medical or surgical castration will be continued for the duration of the trial in all subjects.
  • Platelet Count \<50,000/µL
  • Serum Creatinine \> 3x ULN
  • AST or ALT \> 2.5x ULN unless secondary to liver metastasis (then AST/ALT \> 5x ULN is exclusionary provided subject meets bilirubin requirements)
  • Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment
  • CTCs ≥ 5 per 7.5ml of whole blood performed by CellSearch system within 1 month of enrollment (may be performed as part of screening).
  • Histologic/Cytologic diagnosis of prostate carcinoma
  • Hemoglobin \<8 g/dL
  • Subjects must remain on a stable hormonal therapy regimen.
  • Prior investigational therapy (medications or devices) within 4 weeks of treatment. Furthermore, other investigational anti-cancer therapy is not permitted during the treatment phase.
  • Subjects who have any measure of progression on androgen receptor signaling inhibitors (such as enzalutamide or apalutamide) or CYP17 inhibitors (such as abiraterone acetate) and wish to continue must remain on a stable regimen.
  • ECOG Performance Status \>2
  • Any serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which in the investigator's opinion might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
  • Inclusion Criteria
  • Increase in circulating tumor cell (CTC) count via CellSearch methodology in the absence of responding tumor by other criteria.
  • New lesions on bone scan
  • Subjects capable of fathering children must agree to use an effective method of contraception for the duration of the trial.Exclusion Criteria
  • Progression of disease on CT/MRI as defined by RECIST
  • Absolute Neutrophil Count \<1000/µL

Exclusion

Exclusion criteria not yet provided.