Clinical Trials Directory

Trials / Terminated

TerminatedNCT04927663

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

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
2 (actual)
Sponsor
Rahul Aggarwal · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREComputed TomographyUndergo CT imaging
PROCEDUREMagnetic Resonance ImagingUndergo MRI
PROCEDUREPositron Emission TomographyUndergo PET imaging
DRUG11C-YJH08Given IV
PROCEDUREOptional Tumor BiopsyOptional procedure to obtain tumor tissue

Timeline

Start date
2021-08-10
Primary completion
2025-02-28
Completion
2025-02-28
First posted
2021-06-16
Last updated
2025-05-20
Results posted
2025-05-20

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04927663. Inclusion in this directory is not an endorsement.