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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 89Zr DFOMSTP2109A tracer Group 1 | 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 tracer Group 2 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 89Zr- DFO-MSTP2109A | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Histologically Positive Lesions That Are Positive on Imaging | 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%. | 2 years |
| Number of Participants Evaluated for AEs | 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. | 2 years |
| Rate of Clearance of Tracer 89Zr-DFO-MSTP2109A | 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). | up to 168 hours |
| Biodistribution/SUVmax | 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Histologically Positive Lesions That Were True Positive on PET Imaging | Ability of 89Zr-DFO-MSTP2109A PET to detect sites of metastatic prostate cancer. | 2 years |
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Inclusion Criteria:
Or
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Larson, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36383907 | Derived | 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. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 89Zr DFOMSTP2109A Tracer Group 1 - 10mg | 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:
|
| FG001 | 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. 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No participants recruited for Group 2
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Histologically Positive Lesions That Are Positive on Imaging | 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%. | Participants not enrolled into Group 2 | Posted | Number | 95% Confidence Interval | % of participants with + lesions | 2 years |
|
2 years
Participants not enrolled to Group 2
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Larson, MD | Memorial Sloan Kettering Cancer Center | 646-888-2212 | LarsonS@MSKCC.ORG |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2015 | Apr 17, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 89Zr DFO-MSTP2109A | 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 |
|
| BG001 | 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. 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. 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 | Number of Participants Evaluated for AEs | 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. | Participants not enrolled into Group 2 | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Primary | Rate of Clearance of Tracer 89Zr-DFO-MSTP2109A | 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). | Participants not enrolled to Group 2 | Posted | Median | Full Range | mL/hour | up to 168 hours |
|
|
|
| Primary | Biodistribution/SUVmax | 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 | Participants not enrolled to Group 2 | Posted | Median | Full Range | g/mL | 2 years |
|
|
|
| Secondary | Percentage of Histologically Positive Lesions That Were True Positive on PET Imaging | Ability of 89Zr-DFO-MSTP2109A PET to detect sites of metastatic prostate cancer. | Participants not enrolled in Group 2 | Posted | Number | 95% Confidence Interval | % of positive lesions | 2 years | lesions | lesions |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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. 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |