A Phase I/II Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer

NCT01774071 Phase 1/Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	19
Start date	2013-01
Completion	2023-05-02

Conditions

• Prostate Cancer

Interventions

• 89Zr- DFO-MSTP2109A
• 89Zr DFO-MSTP2109A

Primary outcomes

• Percentage of Participants With Histologically Positive Lesions That Are Positive on Imaging — 2 years
  Antibody imaging will be considered feasible if 75% of the patients are antibody-imaging-positive. We will enroll 6 patients (cohort 1A) at the 10mg dose level for an initial decision on feasibility. If 4 or more of these patients have 20% or more of their active lesions detectable by 89Zr-DFO-MSTP2109A then we will consider the agent feasible for imaging, otherwise we will proceed to cohort 1B. If the true feasibility rate is 40%, this rule will affords more than 82% chance that cohort 1B will be opened for enrollment; this probability is less than 17% if the true feasibility is 75%.
• Number of Participants Evaluated for AEs — 2 years
  All participants will be evaluated for adverse events which will be graded for intensity on a scale of 0 to 5. Severity grades will be recorded and based on the CTCAE v4.0. Adverse events will be defined graded using CTCAE V4.0.
• Rate of Clearance of Tracer 89Zr-DFO-MSTP2109A — up to 168 hours
  Serial blood draws will be used to estimate the pharmacokinetic profile of the 10mg 89Zr-DFO-MSTP2109A in this patient population. Blood samples will be obtained in green top tube: Just prior to injection of 89Zr-DFO-MSTP2109A (baseline)Approximately 5 ± 2, 15 ± 5, 30 ± 9, 60 ± 19, and 120 to 240 minutes after injection of the tracer. One sample at the time of each subsequent day of imaging (24 + 8h, \~48-96h and \~120-168h post injection).
• Biodistribution/SUVmax — 2 years
  A PET-CT scan extending from top of skull to mid thighs will be performed to determine the biodistribution/SUVmax in bone and soft tissue

Countries

United States