Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer

NCT ID: NCT01774071

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2023-05-02

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

89Zr DFOMSTP2109A tracer Group 1

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.

Group Type: EXPERIMENTAL

89Zr- DFO-MSTP2109A

Intervention Type: DRUG

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.

89Zr-DFO-MSTP2109A tracer Group 2

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.

Group Type: EXPERIMENTAL

89Zr DFO-MSTP2109A

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: DRUG

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

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Larson, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36383907 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

12-178

Identifier Type: -

Identifier Source: org_study_id