Trial Outcomes & Findings for 11C-YJH08 PET Imaging for Detection of Glucocorticoid Receptor Expression (NCT NCT04927663)
NCT ID: NCT04927663
Last Updated: 2025-05-20
Results Overview
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.
TERMINATED
PHASE1
2 participants
Up to day 1 follow-up
2025-05-20
Participant Flow
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
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
11C-YJH08 PET Imaging for Detection of Glucocorticoid Receptor Expression
Baseline characteristics by cohort
| Measure |
Cohort A: Any Solid Tumor (Dosimetry Cohort)
n=2 Participants
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
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
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.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
70-79 years
|
1 Participants
n=99 Participants
|
—
|
—
|
1 Participants
n=7 Participants
|
|
Age, Customized
80-89 years
|
1 Participants
n=99 Participants
|
—
|
—
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
—
|
—
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
—
|
—
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
—
|
—
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
—
|
—
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
—
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
—
|
—
|
2 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to day 1 follow-upPopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: No participants were enrolled in Cohort B or C.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: No participants were enrolled in Cohort B or C
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to day 1 after injectionPopulation: No participants were enrolled in Cohort B or C
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.
Outcome measures
| Measure |
Cohort A: Any Solid Tumor (Dosimetry Cohort)
n=2 Participants
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 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.
|
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.
|
|---|---|---|---|
|
Number of Participants With Reported Treatment-emergent Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: No participants were enrolled in Cohort B
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: No participants were enrolled in Cohort B or C
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: No participants were enrolled in Cohorts B or C
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: No participants were enrolled in Cohort B or C
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.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A: Any Solid Tumor (Dosimetry Cohort)
Cohort B: Metastatic CRPC
Cohort C: Solid Tumor Malignancy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rahul Aggarwal, MD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place