11C-YJH08 PET Imaging for Detection of Glucocorticoid Receptor Expression
Status
RECRUITING
Phase
PHASE1
Age
≥ 18 Years
Enrollments
26Conditions
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Solid Tumor, Adult, Solid Tumor, Metastatic Castration-resistant Prostate CancerDrugs
11C-YJH08Summary
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.
Detailed Description
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Khadija Siddiqua
- 310-794-7329
- [email protected]
Principal Investigator
- Rahul Aggarwal, MD
Eligibility Criteria
Inclusion Criteria:
1. Disease characteristics by cohort, as defined by:
* COHORT A: Histologically confirmed metastatic solid tumor malignancy.
* COHORT B: Metastatic castration-resistant prostate cancer with progression on systemic therapies by PCWG3.
* COHORT C: Metastatic advanced solid tumor malignancy other than prostate adenocarcinoma with at least one metastasis on conventional imaging.
2. The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Age 18 years or older at the time of study entry.
5. Adequate organ function, as defined by:
1. Serum creatinine =< 1.5 x upper limit of normal (ULN) OR estimated creatinine clearance > 50 ml/min
2. Total bilirubin =< 1.5 x ULN
3. Hemoglobin >= 8.0 g/dL
4. Platelet count >= 50,000/microliter
5. Absolute neutrophil count >= 1000/microliter
Exclusion Criteria:
1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
2. Concurrent treatment with any dose of systemic glucocorticoids within 7 days prior to cycle 1 day 1 (C1D1).
3. History of adrenal insufficiency requiring use of systemic glucocorticoid replacement.
4. History of Cushing's disease or Cushing's syndrome.
5. Any condition that, in the opinion of the principal investigator, would impair the patient's ability to comply with study procedures.
6. Contra-indication to MRI (e.g. pacemaker placement, severe claustrophobia) (applicable only for patients scheduled for PET/MRI).
Study Plan
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.
PROCEDURE:
Computed TomographyDescription:
Undergo CT imagingPROCEDURE:
Magnetic Resonance ImagingDescription:
Undergo MRIPROCEDURE:
Positron Emission TomographyDescription:
Undergo PET imagingDRUG:
11C-YJH08Description:
Given IVPROCEDURE:
Optional Tumor BiopsyDescription:
Optional procedure to obtain tumor tissue
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.
PROCEDURE:
Computed TomographyDescription:
Undergo CT imagingPROCEDURE:
Magnetic Resonance ImagingDescription:
Undergo MRIPROCEDURE:
Positron Emission TomographyDescription:
Undergo PET imagingDRUG:
11C-YJH08Description:
Given IVPROCEDURE:
Optional Tumor BiopsyDescription:
Optional procedure to obtain tumor tissue
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.
PROCEDURE:
Computed TomographyDescription:
Undergo CT imagingPROCEDURE:
Magnetic Resonance ImagingDescription:
Undergo MRIPROCEDURE:
Positron Emission TomographyDescription:
Undergo PET imagingDRUG:
11C-YJH08Description:
Given IVPROCEDURE:
Optional Tumor BiopsyDescription:
Optional procedure to obtain tumor tissue
Outcome Measures
Primary Outcome Measures
Sensitivity of 11C-YJH08 PET in metastatic lesion detection (Cohort A only)
Median percent change from baseline in standardized uptake value (SUV)max (Cohort B and C only)
Median percent change from baseline at the time of progression in standardized uptake value (SUV)max-ave (Cohort B and C only)
Secondary Outcome Measures
Number of participants with reported treatment-emergent adverse events
Median intra-tumoral uptake
Association between baseline uptake on 11C-YJH08 PET with prostate specific antigen (PSA50) response (Cohort B only )
Association between baseline uptake on 11C-YJH08 PET and objective response rate (Cohort B & C only)
Association between baseline uptake on 11C-YJH08 PET and clinical benefit rate (Cohort B & C only)
Median progression-free survival by cohort (Cohort B & C only)
Timeline
Last Updated
May 29, 2024Start Date
June 16, 2021Today
January 16, 2025Completion Date ( Estimated )
October 31, 2025
Sponsors of this trial
Lead Sponsor
Rahul AggarwalCollaborating Sponsors
U.S. Army Medical Research Acquisition Activity, National Institute of Mental Health (NIMH)
RECRUITING 
21 - 64 Years