Clinical trial · Interventional
11C-YJH08 PET Imaging for Detection of Glucocorticoid Receptor Expression
A First-in-Human, Phase I PET Imaging Study of 11C-YJH08, a Selective Glucocorticoid Receptor-Targeting Agent, in Patients With Advanced Solid Tumor Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-Resistant Prostate Carcinoma | Castration-Resistant Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
| Stage IVA Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 11C-YJH08 | Drug | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Optional Tumor Biopsy | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A: Any Solid Tumor (Dosimetry Cohort)
- description
- 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.
- interventionNames
- Procedure: Computed Tomography
- Procedure: Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
- Drug: 11C-YJH08
- Procedure: Optional Tumor Biopsy
- type
- EXPERIMENTAL
- label
- Cohort B: Metastatic CRPC
- description
- 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.
- interventionNames
- Procedure: Computed Tomography
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 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. 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).
References
Publications (0)
Data not yet available