Clinical trial NCT01774071: Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer
Official title: A Phase I/II Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: 89Zr-DFO-MSTP2109A
tracer
pet scan
12-178
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2013-01-23
Enrollment: 19
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Histologically Positive Lesions That Are Positive on Imaging
timeFrame: 2 years
measure: Number of Participants Evaluated for AEs
timeFrame: 2 years
measure: Rate of Clearance of Tracer 89Zr-DFO-MSTP2109A
timeFrame: up to 168 hours
measure: Biodistribution/SUVmax
timeFrame: 2 years
Secondary outcomes:
measure: Percentage of Histologically Positive Lesions That Were True Positive on PET Imaging
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Steven Larson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martiniova L, Zielinski RJ, Lin M, DePalatis L, Ravizzini GC. The Role of Radiolabeled Monoclonal Antibodies in Cancer Imaging and ADC Treatment. Cancer J. 2022 Nov-Dec 01;28(6):446-453. doi: 10.1097/PPO.0000000000000625.