Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments 89zr- dfo-mstp2109a, 89zr dfo-mstp2109a
Phase phase 1/phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Genentech, Inc.
Start date January 2013
End date January 2017
Trial size 27 participants
Trial identifier NCT01774071, 12-178

Summary

The purpose of this study is to see if a new diagnostic research agent named 89Zr-DFO-MSTP2109A can show prostate cancer tumors on a PET scan; as well as see how long 89Zr-DFO-MSTP2109A lasts in the blood when given in small amounts. DFO-MSTP2109A is an antibody that works against STEAP1 - found on the surface of prostate cancer cells. Attached to the DFO-MSTP2109A is a radioactive material called 89ZR, which allows it to be imaged by a PET scanner. The results of this study may help researchers know whether 89Zr-DFO-MSTP2109A can be used as a diagnostic agent for finding prostate cancer that have STEAP1 on its surface with a PET scanner. The reason why identifying STEAP1 on prostate cancer cells is that new therapies are being developed to target STEAP1 prostate cancer cells.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model crossover assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
The first group of participants will include 6 participants whom will receive 10mg of 89Zr-DFO-MSTP2109A. A second group of 6 participants may receive twice the amount of antibody to determine if this results in better pictures of your tumors. Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2.
89zr- dfo-mstp2109a
If you are enrolled onto Group 1: Once you are given the diagnostic agent, the following procedures will be done: PET scans at the approximate times: 1-4 hours after the injection 24 hours after the injection (the next day, Day 2) 48-120 hours after the injection (on either Day 3, 4, or 5) 144-168 hours after the injection (on either Day 6, 7, or 8) You will also have research bloods drawn on the following times and days, Day 1: before the injection, approximately 5 minutes after, 30 minutes after, 1 hour after and 2-4 hours after the injection. At each time of your scheduled PET scan.
(Experimental)
Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2. Group 2 will include up to 15 participants whom may receive a dose of up to 20mg.
89zr dfo-mstp2109a
If you are enrolled onto Group 2: Once you are given the study drug, the following procedures will be done: You will have one PET scan done. The timing of the PET scan will be determined at the time of your enrollment (~ 3-7 days after injection). No research blood work will be drawn in Group 2

Primary Outcomes

Measure
feasibility
time frame: 2 years
safety and tolerability
time frame: 2 years
Serial blood draws will be used to estimate the pharmacokinetics (PK)
time frame: 2 years
biodistribution
time frame: 2 years

Secondary Outcomes

Measure
ability of 89Zr-DFO-MSTP2109A PET to detect sites of metastatic prostate cancer.
time frame: 2 years

Eligibility Criteria

Male participants at least 21 years old.

Inclusion Criteria: - To be included in this study, patients should be eligible for enrollment into protocol 11-016 (therapy with the DSTP3086S ADC) or meet all of the following criteria: - Patients meeting the criteria for enrollment on research protocol 11-016 to receive DSTP3086S ADC (therapeutic ADC based on MSTP2109A) will be the preferred patients for this study. Patients that are to receive DSTP3086S will not be injected with DSTP2086S until imaging with 89Zr-DFOMSTP2109A is finished, approximately 1 week. - Adult male > 21years of age - Visible lesions by either CT, bone scan or MRI consistent with metastatic disease - Metastatic progressive disease - Imaging modalities: - Bone scan: new osseous lesion and/or MRI or CT: An increase in measurable soft tissue disease or the appearance of new sites of disease. Or - PSA changes over range of value 26% - Patients with histologically confirmed prostate cancer at MSKCC - STEAP1 antigen positive tissue known from prior IHC testing or if STEAP1 status is not known archival sample will be sent to Genentech for IHC. Samples need to be positive, when feasible metastatic lesions will be tested preferentially rather than the primary. - Performance status of 60 or higher (Karnofsky scale) (Appendix A) - Ability to understand and willingness to sign a written informed consent document - PSA levels to be taken within 2 weeks of antibody administration. Exclusion Criteria: - Patients meeting any of the following exclusion criteria will not be eligible for study entry: - Previous anaphylactic reaction to human, humanized or chimeric antibody - Hematologic - Platelets <75K/mcL - ANC <1.0 K/mcL - Hepatic laboratory values - AST/ALT >2.5 x ULN - Renal laboratory values - Bilirubin >1.5 x ULN (institutional upper limits of normal) - eGFR < 30mL/min/1.73m2 - Patients with history of hypersensitivity reaction to any component of 89Zr-DFOMSTP2109A, including DFO

Additional Information

Official title A Phase I/II Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer
Principal investigator Steven Larson, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.
Location data was received from the National Cancer Institute and was last updated in October 2016.