11C-YJH08 PET Imaging for Detection of Glucocorticoid Receptor Expression

NCT04927663 | Terminated Phase 1 Results DMC FDA Drug

• 3 other identifiers: 20926NCI-2021-043005R01MH115043-03
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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 Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• Number of Participants With Reported Treatment-emergent Adverse Events

  Up to day 1 after injection

• Median Intra-tumoral Uptake

  Up to 24 months

• Association Between Baseline Uptake on 11C-YJH08 PET With Prostate Specific Antigen (PSA50) Response (Cohort B Only )

  Up to 24 months

• Association Between Baseline Uptake on 11C-YJH08 PET and Objective Response Rate (Cohort B & C Only)

  Up to 24 months

• Association Between Baseline Uptake on 11C-YJH08 PET and Clinical Benefit Rate (Cohort B & C Only)

  Up to 24 months

Study Arms (3)

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 Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Drug: 11C-YJH08; Procedure: Optional Tumor Biopsy

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 Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Drug: 11C-YJH08; Procedure: Optional Tumor Biopsy

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 Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Drug: 11C-YJH08; Procedure: Optional Tumor Biopsy

Interventions

Computed Tomography PROCEDURE

Undergo CT imaging

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan

Cohort A: Any Solid Tumor (Dosimetry Cohort); Cohort B: Metastatic CRPC; Cohort C: Solid Tumor Malignancy

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Cohort A: Any Solid Tumor (Dosimetry Cohort); Cohort B: Metastatic CRPC; Cohort C: Solid Tumor Malignancy

Positron Emission Tomography PROCEDURE

Undergo PET imaging

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Cohort A: Any Solid Tumor (Dosimetry Cohort); Cohort B: Metastatic CRPC; Cohort C: Solid Tumor Malignancy

11C-YJH08 DRUG

Given IV

Also known as: Radioactive Tag, Radioactive Tracer, Radioactive Label

Cohort A: Any Solid Tumor (Dosimetry Cohort); Cohort B: Metastatic CRPC; Cohort C: Solid Tumor Malignancy

Optional Tumor Biopsy PROCEDURE

Optional procedure to obtain tumor tissue

Also known as: Tumor Biopsy

Cohort A: Any Solid Tumor (Dosimetry Cohort); Cohort B: Metastatic CRPC; Cohort C: Solid Tumor Malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Prostate Specific Antigen Working Group 3 (PSAWG3).
• COHORT C: Metastatic advanced solid tumor malignancy other than prostate adenocarcinoma with at least one metastasis on conventional imaging.
• 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:
• Serum creatinine =\< 1.5 x upper limit of normal (ULN) OR estimated creatinine clearance \> 50 ml/min
• Total bilirubin =\< 1.5 x ULN
• Hemoglobin \>= 8.0 g/dL
• Platelet count \>= 50,000/microliter
• Absolute neutrophil count \>= 1000/microliter

You may not qualify if:

• Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
• Concurrent treatment with any dose of systemic glucocorticoids within 7 days prior to cycle 1 day 1 (C1D1).
• History of adrenal insufficiency requiring use of systemic glucocorticoid replacement.
• History of Cushing's disease or Cushing's syndrome.
• Any condition that, in the opinion of the principal investigator, would impair the patient's ability to comply with study procedures.
• Contra-indication to MRI (e.g. pacemaker placement, severe claustrophobia) (applicable only for patients scheduled for PET/MRI).

Sponsors & Collaborators

• Rahul Aggarwal: lead
• U.S. Army Medical Research Acquisition Activity: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Radioactive Tracers

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Radioisotopes; Isotopes; Inorganic Chemicals; Indicators and Reagents; Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses

Limitations and Caveats

Study closed earlier than expected due to slow accrual

Results Point of Contact

• Title: Dr. Rahul Aggarwal, MD
• Organization: University of California, San Francisco

rahul.aggarwal@ucsf.edu

(415) 353-7171

Study Officials

• Rahul Aggarwal, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: August 10, 2021
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)