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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-04300 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 5R01MH115043-03 | U.S. NIH Grant/Contract | View source |
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Slow accrual
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| Name | Class |
|---|---|
| U.S. Army Medical Research Acquisition Activity | FED |
| National Institute of Mental Health (NIMH) | NIH |
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This phase I trial studies if positron emission tomography (PET) imaging using 11C-YJH08 can be useful for detecting certain cell receptor expression in tumor cells in patients with cancer that has spread to other parts of the body (metastatic). 11C-YJH08 is a small-molecule radiotracer that binds to receptors on cells (glucocorticoid receptor) so that they show up better on the PET scan. Systemic therapy (including enzalutamide) can cause more glucocorticoid receptors to be produced in tumor cells, which can make the tumor cells resist hormone therapies. If researchers can find a better way to detect whether glucocorticoid receptors are increasing during therapy, it may lead to more successful therapies using glucocorticoid receptor antagonists.
PRIMARY OBJECTIVES:
I. To determine the feasibility of metastatic lesion detection in enzalutamide/apalutamide-resistant metastatic castration-resistant prostate cancer (mCRPC) using 11C-YJH08 PET. (Cohort A).
II. To determine the mean percent change from baseline at the time of progression on enzalutamide or apalutamide in standardized uptake value (SUV)max-ave on paired 11C-YJH08 PET on a per-patient and per-lesion basis. (Cohorts B & C).
SECONDARY OBJECTIVES:
I. To determine the safety and determine average organ uptake of 11C-YJH08. II. To descriptively report the patterns of intra-tumoral uptake of 11C-YJH08 on whole body PET, including by site of disease, uptake by tumor type, inter-tumoral and inter-patient heterogeneity, and tumor-to-background signal.
III. To determine whether baseline uptake on 11C-YJH08 PET is associated with subsequent clinical outcomes including objective response rate, progression-free survival, and prostate specific antigen (PSA50) response. (Cohorts B & C)
EXPLORATORY OBJECTIVE:
I. To determine the association between uptake on 11C-YJH08 PET with glucocorticoid receptor (GR) expression and transcriptional signature scores on paired metastatic tumor biopsies.
OUTLINE: Participants are assigned to 1 of 3 arms.
Cohort A (Dosimetry): Participants receive 11C-YJH08 intravenously (IV) over 1-2 minutes and 10-60 minutes later, undergo either PET/magnetic resonance imaging (MRI) or PET/computed tomography (CT) over 90 minutes at baseline.
**Enrollment in Cohorts B & C will enroll after dosimetry has been established in Cohort A**
Cohort B: Participants with mCRPC receive 11C-YJH08 and undergo either PET/MRI or PET/CT at baseline and at time of progression.
Cohort C: Participants with solid tumors receive 11C-YJH08 and undergo either PET/MRI or PET/CT at baseline and at time of progression.
Participants are assessed the day of the scan for safety follow-up, and up to 24 months for non-interventional clinical outcomes. An optional metastatic tumor biopsy may be performed within 14 days of the initial scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Any Solid Tumor (Dosimetry Cohort) | Experimental | Participants with any solid tumor malignancy with evidence of one or more metastases will receive approximately 20 millicurie (mCi) of 11C-YJH08 IV over 1-2 minutes and 10-60 minutes later, undergo either PET/MRI or PET/CT over 90 minutes at baseline. |
|
| Cohort B: Metastatic CRPC | Experimental | Participants with metastatic CRPC will receive approximately 20 mCi of 11C-YJH08 IV over 1-2 minutes and 10-60 minutes later, undergo either PET/MRI or PET/CT over 90 minutes at baseline and optional repeat scan at the time of progression. |
|
| Cohort C: Solid Tumor Malignancy | Experimental | Participants with any solid tumor malignancies other than prostate adenocarcinoma with one or more metastases on conventional imaging will receive approximately 20 mCi of 11C-YJH08 IV over 1-2 minutes and 10-60 minutes later, undergo either PET/MRI or PET/CT over 90 minutes at baseline and optional repeat scan at the time of progression. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo CT imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of 11C-YJH08 PET in Metastatic Lesion Detection (Cohort A Only) | Using as a cut-off to define a positive lesion on PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the sensitivity (probability that a test will indicate recurrent disease among those with recurrent disease (True Positive / (True Positive + False Negative)) will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including computed tomography or magnetic resonance imaging of the chest/abdomen/pelvis. | Up to day 1 follow-up |
| Median Percent Change From Baseline in Standardized Uptake Value (SUV)Max (Cohort B and C Only) | The median percent change from baseline, and range of SUVmax (across all metastatic lesions per patient) will be descriptively reported using mediastinal blood pool and normal organ as background uptake values. | Up to 24 months |
| Median Percent Change From Baseline at the Time of Progression in Standardized Uptake Value (SUV)Max-ave (Cohort B and C Only) | The median percent change from baseline, and range of SUVmax-ave (in each study cohort) will be descriptively reported using mediastinal blood pool and normal organ as background uptake values. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Reported Treatment-emergent Adverse Events | The frequency and severity of adverse events following 11C-YJH08 injection will be descriptively reported, using NCI Common Terminology Criteria for Adverse Events Version 5.0 criteria. | Up to day 1 after injection |
| Median Intra-tumoral Uptake |
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Inclusion Criteria:
Disease characteristics by cohort, as defined by:
The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Age 18 years or older at the time of study entry.
Adequate organ function, as defined by:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rahul Aggarwal, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
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Only 2 participants were enrolled to Cohort A. The study was closed for slow accrual before enrollment in Cohort B or Cohort C could begin
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Any Solid Tumor (Dosimetry Cohort) | Participants with any solid tumor malignancy with evidence of one or more metastases will receive approximately 20 millicurie (mCi) of 11C-YJH08 IV over 1-2 minutes and 10-60 minutes later, undergo either Positron Emission Tomography (PET)/MRI or PET/CT over 90 minutes at baseline. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Apr 24, 2024 |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI |
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| Positron Emission Tomography | Procedure | Undergo PET imaging |
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| 11C-YJH08 | Drug | Given IV |
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| Optional Tumor Biopsy | Procedure | Optional procedure to obtain tumor tissue |
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The median and range for intra-tumoral SUVmax within metastatic lesions will be descriptively reported to asses for intra-tumoral heterogeneity and differences in uptake by site of disease. |
| Up to 24 months |
| Association Between Baseline Uptake on 11C-YJH08 PET With Prostate Specific Antigen (PSA50) Response (Cohort B Only ) | The association between baseline and percent change from baseline in SUVmax-ave with the cohort will be dichotomized above and below the median will be compared to the PSA response rate using Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria | Up to 24 months |
| Association Between Baseline Uptake on 11C-YJH08 PET and Objective Response Rate (Cohort B & C Only) | The association between baseline and percent change from baseline in SUVmax-ave with the cohort will be dichotomized above and below the median will be compared to the objective response rate (in subset of measurable tumors by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1) | Up to 24 months |
| Association Between Baseline Uptake on 11C-YJH08 PET and Clinical Benefit Rate (Cohort B & C Only) | The association between baseline and percent change from baseline in SUVmax-ave with the cohort will be dichotomized above and below the median will be compared to the clinical benefit rate (in subset of measurable tumors by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1) | Up to 24 months |
| Median Progression-free Survival by Cohort (Cohort B & C Only) | The association between baseline and percent change from baseline in SUVmax-ave with the cohort will be dichotomized above and below the median and median progression-free survival will be reported by group. | Up to 24 months |
| Cohort B: Metastatic CRPC |
Participants with metastatic castrate resistant prostate cancer (CRPC) will receive approximately 20 mCi of 11C-YJH08 IV over 1-2 minutes and 10-60 minutes later, undergo either PET/MRI or PET/CT over 90 minutes at baseline and optional repeat scan at the time of progression. |
| FG002 | Cohort C: Solid Tumor Malignancy | Participants with any solid tumor malignancies other than prostate adenocarcinoma with one or more metastases on conventional imaging will receive approximately 20 mCi of 11C-YJH08 IV over 1-2 minutes and 10-60 minutes later, undergo either PET/MRI or PET/CT over 90 minutes at baseline and optional repeat scan at the time of progression. |
| COMPLETED |
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| NOT COMPLETED |
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The study closed before Cohorts B and C could be opened for enrollment
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Any Solid Tumor (Dosimetry Cohort) | Participants with any solid tumor malignancy with evidence of one or more metastases will receive approximately 20 millicurie (mCi) of 11C-YJH08 IV over 1-2 minutes and 10-60 minutes later, undergo either PET/MRI or PET/CT over 90 minutes at baseline. |
| BG001 | Cohort B: Metastatic CRPC | Participants with metastatic CRPC will receive approximately 20 mCi of 11C-YJH08 IV over 1-2 minutes and 10-60 minutes later, undergo either PET/MRI or PET/CT over 90 minutes at baseline and optional repeat scan at the time of progression. |
| BG002 | Cohort C: Solid Tumor Malignancy | Participants with any solid tumor malignancies other than prostate adenocarcinoma with one or more metastases on conventional imaging will receive approximately 20 mCi of 11C-YJH08 IV over 1-2 minutes and 10-60 minutes later, undergo either PET/MRI or PET/CT over 90 minutes at baseline and optional repeat scan at the time of progression. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Sensitivity of 11C-YJH08 PET in Metastatic Lesion Detection (Cohort A Only) | Using as a cut-off to define a positive lesion on PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the sensitivity (probability that a test will indicate recurrent disease among those with recurrent disease (True Positive / (True Positive + False Negative)) will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including computed tomography or magnetic resonance imaging of the chest/abdomen/pelvis. | Data not collected. Per the pre-specified statistical analysis plan outlined in the study protocol, a sample size of approximately 6 patients for Cohort A is required to collect sufficient data to ensure adequate organ dosimetry and determination of the optimal uptake time following administration of 11C-YJH08. | Posted | Up to day 1 follow-up |
|
| ||||||||||||||||||||
| Primary | Median Percent Change From Baseline in Standardized Uptake Value (SUV)Max (Cohort B and C Only) | The median percent change from baseline, and range of SUVmax (across all metastatic lesions per patient) will be descriptively reported using mediastinal blood pool and normal organ as background uptake values. | No participants were enrolled in Cohort B or C. | Posted | Up to 24 months |
|
| ||||||||||||||||||||
| Primary | Median Percent Change From Baseline at the Time of Progression in Standardized Uptake Value (SUV)Max-ave (Cohort B and C Only) | The median percent change from baseline, and range of SUVmax-ave (in each study cohort) will be descriptively reported using mediastinal blood pool and normal organ as background uptake values. | No participants were enrolled in Cohort B or C | Posted | Up to 24 months |
|
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| Secondary | Number of Participants With Reported Treatment-emergent Adverse Events | The frequency and severity of adverse events following 11C-YJH08 injection will be descriptively reported, using NCI Common Terminology Criteria for Adverse Events Version 5.0 criteria. | No participants were enrolled in Cohort B or C | Posted | Count of Participants | Participants | Up to day 1 after injection |
| |||||||||||||||||||
| Secondary | Median Intra-tumoral Uptake | The median and range for intra-tumoral SUVmax within metastatic lesions will be descriptively reported to asses for intra-tumoral heterogeneity and differences in uptake by site of disease. | Data not collected. Per the pre-specified statistical analysis plan outlined in the study protocol, a sample size of approximately 6 patients for Cohort A is required to collect sufficient data to ensure adequate organ dosimetry and determination of the optimal uptake time following administration of 11C-YJH08. | Posted | Up to 24 months |
| |||||||||||||||||||||
| Secondary | Association Between Baseline Uptake on 11C-YJH08 PET With Prostate Specific Antigen (PSA50) Response (Cohort B Only ) | The association between baseline and percent change from baseline in SUVmax-ave with the cohort will be dichotomized above and below the median will be compared to the PSA response rate using Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria | No participants were enrolled in Cohort B | Posted | Up to 24 months |
|
| ||||||||||||||||||||
| Secondary | Association Between Baseline Uptake on 11C-YJH08 PET and Objective Response Rate (Cohort B & C Only) | The association between baseline and percent change from baseline in SUVmax-ave with the cohort will be dichotomized above and below the median will be compared to the objective response rate (in subset of measurable tumors by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1) | No participants were enrolled in Cohort B or C | Posted | Up to 24 months |
|
| ||||||||||||||||||||
| Secondary | Association Between Baseline Uptake on 11C-YJH08 PET and Clinical Benefit Rate (Cohort B & C Only) | The association between baseline and percent change from baseline in SUVmax-ave with the cohort will be dichotomized above and below the median will be compared to the clinical benefit rate (in subset of measurable tumors by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1) | No participants were enrolled in Cohorts B or C | Posted | Up to 24 months |
|
| ||||||||||||||||||||
| Secondary | Median Progression-free Survival by Cohort (Cohort B & C Only) | The association between baseline and percent change from baseline in SUVmax-ave with the cohort will be dichotomized above and below the median and median progression-free survival will be reported by group. | No participants were enrolled in Cohort B or C | Posted | Up to 24 months |
|
|
Up to 2 days
The study closed to slow accrual before Cohorts B or C could be opened for enrollment.
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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 | Cohort A: Any Solid Tumor (Dosimetry Cohort) | Participants with any solid tumor malignancy with evidence of one or more metastases will receive approximately 20 millicurie (mCi) of 11C-YJH08 IV over 1-2 minutes and 10-60 minutes later, undergo either PET/MRI or PET/CT over 90 minutes at baseline. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | Cohort B: Metastatic CRPC | Participants with metastatic CRPC will receive approximately 20 mCi of 11C-YJH08 IV over 1-2 minutes and 10-60 minutes later, undergo either PET/MRI or PET/CT over 90 minutes at baseline and optional repeat scan at the time of progression. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Cohort C: Solid Tumor Malignancy | Participants with any solid tumor malignancies other than prostate adenocarcinoma with one or more metastases on conventional imaging will receive approximately 20 mCi of 11C-YJH08 IV over 1-2 minutes and 10-60 minutes later, undergo either PET/MRI or PET/CT over 90 minutes at baseline and optional repeat scan at the time of progression. | 0 | 0 | 0 | 0 | 0 | 0 |
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Study closed earlier than expected due to slow accrual
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rahul Aggarwal, MD | University of California, San Francisco | (415) 353-7171 | rahul.aggarwal@ucsf.edu |
| Mar 21, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 13, 2024 | Mar 21, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D011849 | Radioactive Tracers |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D011868 | Radioisotopes |
| D007554 | Isotopes |
| D007287 | Inorganic Chemicals |
| D007202 | Indicators and Reagents |
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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| Participants |
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