NCT02693860

Neoadjuvant J591 Treatment for Prostate Cancer

A Pilot Study of Neoadjuvant Monoclonal Antibody Humanised (hu) J591 for the Treatment of High and/or Intermediate-Risk Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

10 patients will be enrolled in the initial cohort and will receive two infusions of unlabeled huJ591 on days 1 and 14. 89Zr-J591 will be administered on day 21 (+ 1 day) and a positron emission tomography-computed tomography (PET/CT) will be performed week later on day 28 + 1 (visit 4). Approximately 2 to 3 weeks after the 2nd dose of J591, the patient will undergo radical prostatectomy with or without lymph node dissection (day 31 + 4 days). The final visit for the study will include a postoperative visit two weeks following surgery.

Detailed description

This is an open-label, single center pilot study to evaluate the efficacy of huJ591 to trigger antibody-dependent cellular cytotoxicity (ADCC) response manifested by a peri-tumoral inflammatory response with or without apoptosis of prostate cancer cells in patients diagnosed with either high or intermediate-risk prostate cancer. To participate the patients will be required to meet all eligibility criteria. Patients may not participate in other clinical trials while undergoing therapeutic treatment. The initial screening period (up to 28 days prior to start of treatment under this clinical trial) consists of visit to confirm eligibility, discuss the risks / benefits of participating in the trial and radical prostatectomy (with or without lymph node dissection), and obtain patient prostate biopsy samples for anti-prostate specific membrane antigen (PSMA) expression review. An enrolled subject's participation in the study entails approximately 6 to 7 weeks of therapy along with the additional 2 weeks time involved in recovery from a radical prostatectomy. Adverse events will be collected throughout the entirety of the study. The total duration of the patient being in the study can be around 9 to 11 weeks. Medical information/Survival information will be collected from the routine followup visits (standard of care) for up to 3 years after the surgery.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	huJ591	Antibody is derived from a hybridoma originally produced in the Weill Medical College Laboratory of Urological Oncology. Treatment with 100 mg of HuJ591 will be administered as an intravenous infusion at a concentration of 5 mg/mL and rate of \<5 mg/minute.
DRUG	89Zr-J591	Drug product is manufactured by the radiochemistry staff of Citigroup Biomedical Imaging Center (CBIC) research core facility. Radiolabeling of DFO-huJ591 with 89Zr is achieved by the addition of 89Zr-oxalate to the DFO-huJ591 in ammonium acetate buffer.

Timeline

• Start date: 2016-02-04
• Primary completion: 2017-02-10
• Completion: 2020-02-02
• First posted: 2016-02-29
• Last updated: 2020-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study