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
Phase: PHASE1
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
Sponsor: Rahul Aggarwal

Proprietary and Confidential
The information in this document is considered privileged and confidential, and may not be disclosed to others except 
to the extent necessary to obtain Institutional Review Board approval and informed consent, or as required by federal 
and state laws.  Persons to whom this information is disclosed should be informed that this information is privileged 
and confidential and that it should not be further disclosed.
A First-in-Human, Phase 1 PET imaging Study of 11C-
YJH08, a Selective Glucocorticoid Receptor-Targeting 
Agent, in Patients with Advanced Solid Tumor 
Malignancies
Protocol Number:  CC# 20926
Investigational Medicinal Product: 11C-YJH08
Version Number: 5.5
Version Date: 04/24/2024
IND Number: 155010
NCT Number: NCT04927663
Principal Investigator 
Rahul Aggarwal, MD 
University of California, San Francisco
 
Co-Principal Investigators 
Spencer Behr, MD
Statistician
Li Zhang, Ph.D.
Revision History
Version 1.0 
11/15/2019
Version 2.0
01/11/2020
Version 3.0
02/07/2020
Version 4.0
03/09/2020
Version 5.0
04/02/2021
Version 5.1
11/30/2021
Version 5.2
02/17/2022
Version 5.3
05/24/2023
Version 5.4
01/24/2024
Version 5.5
04/24/2024

UCSF Helen Diller Family Comprehensive Cancer Center
Version date: 04/24/2024
Protocol CC#: 20926
Phase I – 11C-YJH08
Page 2 of 39
Protocol Signature Page
1.
I agree to follow this protocol version as approved by the UCSF Protocol Review Committee 
(PRC), Institutional Review Board (IRB), and Data and Safety Monitoring Committee 
(DSMC). 
2.
I will conduct the study in accordance with Good Clinical Practices (ICH-GCP) and the 
applicable IRB, ethical, federal, state, and local regulatory requirements. 
3.
I certify that I, and the study staff, have received the required training to conduct this 
research protocol. 
4.
I agree to maintain adequate and accurate records in accordance with IRB policies, federal, 
state and local laws and regulations.
UCSF Principal Investigator 
Printed Name
Signature
Date

UCSF Helen Diller Family Comprehensive Cancer Center
Version date: 04/24/2024
Protocol CC#: 20926
Phase I – 11C-YJH08
Page 3 of 39
Abstract
Title
A First-in-Human, Phase 1 PET imaging Study of 11C-YJH08, a 
Selective Glucocorticoid Receptor-Targeting Agent, in Patients with 
Advanced Solid Tumor Malignancies 
Study Description
This is a first-in-human phase 1 imaging study of 11C-YJH08 PET 
in patients with advanced solid tumor malignancies, with a 
particular focus on enzalutamide/apalutamide-resistant mCRPC.  
Phase of Study
Phase 1
Investigational 
Medicinal 
Product
11C-YJH08 at a dose of up to 20 mCi will be administered. It will be 
injected intravenously. For cohort A (n = 6), dosimetry calculation 
will be performed by obtaining whole body (vertex to thighs) PET 
images up to five time points during 0-90 minutes post injections.  
For cohort B and C (n=10 each), one time point will be obtained 
based on the results of cohort A.  
Study 
population
Approximately 26 patients total will be enrolled in one of two 
following cohorts: 
Cohort A (N = 6 patients): Patients with any solid tumor malignancy 
with evidence of one or metastases on conventional imaging.  
Cohort B (N = 10 patients): Patients with metastatic CRPC will 
undergo 11C-YJH08 PET at the time of progression by PCWG3 
criteria on systemic therapies (e.g. enzalutamide, apalutamide or 
darolutamide). 
Cohort C (N = 10 patients): Patients with any solid tumor 
malignancies other than prostate adenocarcinoma with one or 
more metastases on conventional imaging. Enrollment in Cohort B 
and C will be conducted after completion of enrollment in Cohort A. 
Rationale for 
Study
The proposed patient studies represent the first-ever cancer patient 
imaging studies with 11C-YJH08 PET. The patient population for 
Cohort A is designed to determine the dosimetry of the imaging 
agent, and will enroll any solid tumor malignancy. The patient 
population for Cohort B is designed to enrich for GR-overexpressing 
tumors, by selecting mCRPC patients at the time of progression by 
PCWG criteria on systemic therapies. And Cohort C is designed to 
include patients with any solid tumor malignancies other than 
prostate adenocarcinoma with one or more metastases on 
conventional imaging. Successful completion of the dosimetry cohort 
(Cohort A) will provide the necessary preliminary data to support 
subsequent enrollment in Cohort B and C. 
Primary Objectives
1.
Cohort A: To determine the feasibility of metastatic lesion 
detection in using 11C-YJH08 PET.  
2.
Cohort B and C: To determine the mean percent change from 
baseline at the time of progression on systemic therapy in 
SUVmax-ave on paired 11C-YJH08 PET on a per-patient and per-
lesion basis. 

UCSF Helen Diller Family Comprehensive Cancer Center
Version date: 04/24/2024
Protocol CC#: 20926
Phase I – 11C-YJH08
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Secondary 
Objectives
1.
To determine the safety and determine average organ uptake 
of 11C-YJH08.
2.
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. 
3.
Cohort B and C: To determine whether baseline uptake on 
11C-YJH08 PET is associated with subsequent clinical 
outcomes including objective response rate, progression-free 
survival, and PSA50 response.
Exploratory 
Objective
To determine the association between uptake on 11C-YJH08 PET 
with GR expression and transcriptional signature scores on paired 
metastatic tumor biopsies. 
Sample size
Approximately 26 patients with various solid tumor malignancies 
will be enrolled in the two cohorts as outlined above. 
Duration of study
Approximately 18-24 months from date of first patient enrolled. 
Safety 
Assessments
Safety monitoring will include adverse event assessment during 
Screening, 60 minutes (+/- 15 min), and 2 hours (+/- 30 min) and 
24 hours (+/- 4 hours) following 11C-YJH08 injection. 
Study Schema

UCSF Helen Diller Family Comprehensive Cancer Center
Version date: 04/24/2024
Protocol CC#: 20926
Phase I – 11C-YJH08
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List of Abbreviations
AE
adverse event
ALP
alkaline phosphatase
ALT
alanine aminotransferase
AST
aspartate aminotransferase
BUN
blood urea nitrogen
CBC
complete blood cell (count)
CNS
central nervous system
CR
complete response
CRF
case report form
CT
computerized tomography
CTCAE
Common Terminology Criteria for Adverse Events
CTMS
Clinical Trial Management System
DFS
disease-free survival
DLT
dose limiting toxicity
DSMC
Data and Safety Monitoring Committee
DSMP
Data and Safety Monitoring Plan
ECG/EKG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
FDA
Food and Drug Administration
FDG
Fluorodeoxyglucose
FLC
free light chain
GCP
Good Clinical Practice
GFR
glomerular filtration rate
HBeAg
hepatitis B “e” antigen
HBV
hepatitis B virus
HCV
hepatitis C virus
HDFCCC
Helen Diller Family Comprehensive Cancer Center
HIPAA
Health Insurance Portability and Accountability Act
HIV
human immunodeficiency virus
ICF
informed consent form
ICH
International Conference on Harmonization
IDS
Investigational Drug Services (UCSF)
IND
investigational new drug application
IP
investigational product
IRB
Institutional Review Board

UCSF Helen Diller Family Comprehensive Cancer Center
Version date: 04/24/2024
Protocol CC#: 20926
Phase I – 11C-YJH08
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List of Abbreviations
IV
intravenous
LDH
lactate dehydrogenase
MRI
magnetic resonance imaging
MTD
maximum tolerated dose
NCI
National Cancer Institute
ORR
overall response rate
PD
disease progression
PK
pharmacokinetics
PO
Per os (by mouth, orally)
PR
partial response
PRC
Protocol Review Committee (UCSF)
SD
stable disease
SGOT
serum glutamic oxaloacetic transaminase
SGPT
serum glutamic pyruvic transaminase

UCSF Helen Diller Family Comprehensive Cancer Center
Version date: 04/24/2024
Protocol CC#: 20926
Phase I – 11C-YJH08
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Table of Contents
Protocol Signature Page........................................................................................2
Abstract..................................................................................................................3
List of Abbreviations ..............................................................................................5
1
Introduction ...................................................................................................10
1.1
Background and Rationale ......................................................................10
1.2
Pre-Clinical Data......................................................................................11
1.3
Overall Study Rationale...........................................................................13
2
Study Objectives and Hypotheses ................................................................16
2.1
Study Hypotheses....................................................................................16
2.2
Primary Objectives...................................................................................16
2.3
Secondary Objectives..............................................................................17
2.4
Exploratory Objective...............................................................................18
3
Study Design.................................................................................................18
3.1
Characteristics.........................................................................................18
3.2
Number of Subjects .................................................................................18
3.3
Eligibility Criteria ......................................................................................18
3.3.1
Inclusion Criteria ..........................................................................................19
3.3.2
Exclusion Criteria..........................................................................................19
3.4
Study Timeline.........................................................................................20
3.4.1
Primary Completion .....................................................................................20
3.4.2
Study Termination........................................................................................20
4
Investigational Medicinal Product..................................................................20
5
Study Procedures and Schedules of Events.................................................20
5.1
Participant Registration............................................................................20
5.2
Schedule of Procedures and Assessments.............................................20
5.2.1
Screening Assessments ................................................................................20
5.2.2
Day 1, Baseline 11C-YJH08 PET......................................................................21
5.2.3
OPTIONAL 11C-YJH08 PET at Progression (Cohorts B and C).........................22
Supportive Care................................................................................................24
6
Reporting and Documentation of Results .....................................................24
6.1
Evaluation of Safety.................................................................................24
6.2
Definitions of Adverse Events..................................................................24

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Phase I – 11C-YJH08
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Table of Contents
6.2.1
Adverse Event ..............................................................................................24
6.2.2
Adverse Reaction .........................................................................................24
6.2.3
Suspected Adverse Reaction........................................................................24
6.2.4
Unexpected..................................................................................................24
6.2.5
Serious..........................................................................................................25
6.2.6
Serious..........................................................................................................25
6.3
Recording of an Adverse Event...............................................................25
6.4
Follow-up of Adverse Events...................................................................26
6.5
Adverse Events Monitoring......................................................................26
6.6
Expedited Reporting ................................................................................27
6.6.1
Reporting to the Data and Safety Monitoring Committee...........................27
6.6.2
Reporting to UCSF Institutional Review Board.............................................27
6.6.3
Expedited Reporting to the Food and Drug Administration ........................27
7
Statistical Analysis ........................................................................................28
7.1
Imaging Analysis......................................................................................28
7.2
Determination of Sample Size .................................................................28
7.3
Subject Characteristics............................................................................28
7.4
Replacement Policy.................................................................................28
7.5
Accrual estimates ....................................................................................29
7.6
Interim Analysis .......................................................................................29
7.7
Analytic Plan............................................................................................29
7.7.1
Analysis Population......................................................................................29
7.7.2
Primary Analysis...........................................................................................29
7.7.3
Analysis of Secondary and Exploratory Endpoints.......................................29
8
Study Management.......................................................................................30
8.1
Pre-study Documentation ........................................................................30
8.2
Institutional Review Board Approval........................................................30
8.3
Informed Consent ....................................................................................30
8.4
Changes in the Protocol ..........................................................................31
8.5
Handling and Documentation of Clinical Supplies...................................31
8.6
Case Report Forms (CRFs).....................................................................31
8.7
Oversight and Monitoring Plan ................................................................31

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Phase I – 11C-YJH08
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Table of Contents
8.8
Record Keeping and Record Retention...................................................32
9
References....................................................................................................33
Appendix 1 Performance Status Criteria.............................................................35
Appendix 2 Data and Safety Monitoring Plan for a Non-therapeutic Institutional 
Trial
36

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Version date: 04/24/2024
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Phase I – 11C-YJH08
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1
Introduction
1.1Background and Rationale
With the widespread clinical implementation of potent and selective inhibitors of the androgen 
receptor for the treatment of CRPC, there is now an urgent unmet need to define and overcome 
mechanisms of resistance to these therapies. The landscape of resistance mechanisms to 
therapies like the AR antagonist Enz is highly complex, with several molecularly discrete 
mechanisms defined in preclinical models, and no clear understanding as to their relative 
incidence in patients.  Moreover, biological screening to identify which mechanism(s) may have 
arisen in a given patient is not routine clinical practice, which complicates the development of 
well-organized clinical studies with experimental therapeutics to determine which resistance 
pathways are treatable. 
Appreciating these concerns, several years ago we began developing small molecule 
radiotracers for PET to identify Enz resistant CRPC lesions that express GR.  Our interest in this 
area stemmed from early preclinical reports showing that GR overexpression in human prostate 
cancer xenografts was a spontaneous response to chronic Enz treatment, and GR 
transcriptional activity overcame the antitumor effects of Enz therapy in vitro and in vivo (Figure 
1A).  Since this milestone, numerous manuscripts from other labs have disclosed biological 
findings supportive and consistent with these data.  Moreover, preclinical studies have shown 
that dual AR/GR antagonists, or selective GR antagonists paired with Enz have antitumor 
activity (Figure 1B). Collectively, these data strongly support a role for GR expression and 
biology in resistance to anti-androgen therapy, and three ongoing clinical trials are testing the 
therapeutic potential of overcoming treatment resistant CRPC with GR antagonists more 
systematically (CORT125281: NCT03437941; ORIC-101: NCT03928314; RU486: 
NCT02012296).
With the current enthusiasm for GR as a drug target, the timing is ideal to conduct human 
imaging studies to determine if GR expression in mCRPC can be visualized on PET.  Achieving 
Figure 1. GR signaling as a mechanism of resistance to standard of care therapies for mCRPC that target 
AR. A. A schema showing how GR overexpression by CRPC cells can bypass the effects of Enz. For example, 
GR in complex with cortisol can bind to androgen response elements to induce transcription. Moreover, 
activation of E3 ligases like AMFR can lead to ubiquitin-mediated suppression of 11-HSD2, which in turn 
increases cortisol within CRPC cells. B. Structures of three GR antagonists currently in clinical trials to test if 
GR suppression can extend overall survival in patients with mCRPC and other cancers.  The structure of YJH08, 
the radiotracer we developed to measure GR expression in cells with PET, is also shown.  The methyl group 
colored in red shows the site of radiolabeling with carbon-11.  

UCSF Helen Diller Family Comprehensive Cancer Center
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Protocol CC#: 20926
Phase I – 11C-YJH08
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this goal would empower the community with a crucial companion diagnostic for (1) 
prospectively identifying patients whose tumors express GR to evade Enz (and therefore may 
be likely to respond to a GR antagonist), and (2) studying the PD effects of GR antagonists 
holistically to identify dosing strategies that maximize antitumor effects while minimizing on-
target, off tissue effects.
Our studies identified a small molecule radiotracer, termed 11C-YJH08 that specifically 
binds to GR in rodent models, and has excellent pharmacokinetic properties (Figure 1B). 
1.2Pre-Clinical Data
Our first-generation radiotracers targeting GR were derivatives of potent and GR-selective 
corticosteroids.  We made two molecules, termed 18F-GR01 and 18F-GR02, which were both 
potent and selective for GR in vitro (Figure 2A).  18F-GR01 was quickly abandoned due to 
metabolic instability in vivo.  While 18F-GR02 was highly stable in vivo, and specifically bound to 
GR in normal and prostate cancer tissue, the uptake of 18F-GR02 was very low in prostate 
cancer tumors compared to virtually all normal tissues, including clinically relevant tissues like 
the bone (Figure 2B).  After publishing our findings in Oncotarget, we began developing 
second-generation radiotracers that we expected would have better pharmacokinetics and 
tissue exposure. 
Figure 2. First-generation radiotracers developed during 
the FY14 IDA were suboptimal for prostate cancer 
detection. A. Two steroid-based radiotracers, GR01 and 
GR02 were potent and selective for GR. However, GR01 was 
unstable in vivo. B. While 18F-GR02 was stable, and the tracer 
bound GR in tumors, the uptake in prostate cancer was 
significantly lower than normal tissues and equivalent to 
bone.

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Phase I – 11C-YJH08
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After a focused medicinal chemistry screen, we discovered YJH08, a non-steroidal GR 
modulator with high affinity for GR (Kd ~ 0.4 nM) and at least 100-fold lower affinity for nuclear 
hormone receptors in the same family (Table 1).
To prepare 11C-YJH08, the phenol 1 was 
alkylated with 11C-methyl iodide 
(produced by the UCSF cyclotron and 
radiopharmacy) using chemistry that is 
applicable to GMP radiotracer 
synthesis11.  The decay corrected yield 
was ~52% and the radiochemical purity 
was >99% (Figure 3).  The specific 
activity was calculated to be 880 
Ci/mmol.  Parenthetically, we were also 
able to prepare 18F-YJH08.  While the 
yield was sufficiently high for animal and 
human studies (~12%), and fluorine-18 is more widely available than carbon-11, we opted to 
pursue 11C-YJH08 for further studies given that the radiochemistry was more adaptable to 
clinical translation.
To characterize the biodistribution of 11C-
YJH08 in vivo, we first conducted a dynamic 
PET scan over 60 min in immunocompetent 
male C57Bl6/J mice. Region of interest 
analysis was applied to generate time activity 
curves, which showed that the radiotracer 
rapidly cleared from serum, as expected.  
We also observed radiotracer uptake in 
normal tissues known to harbor high GR 
expression.  For instance, radiotracer uptake 
in the brain was very high (~2% ID/cc), and 
~100 fold higher than what was observed for 
18F-GR02. Moreover, we observed high 
uptake in supraspinal brown adipose tissue 
(~4% ID/cc), a tissue in which GR expression 
is understood to control seminal processes 
like thermogenesis. Radiotracer uptake in the bone was low (<0.5% ID/cc), suggesting the 
radiotracer could be useful for detecting osseous mCRPC.  Although radiotracer uptake in the 
liver was high, liver is not a common site of metastasis for mCRPC adenocarcinoma.
Table 1. In vitro affinity data show that YJH08 is a potent 
and selective ligand for GR. These data were collected in 
cells overexpressing the indicated full-length nuclear 
hormone receptor using a ligand displacement assay. 
Reference ligands were dexamethasone, DHT, progesterone, 
estradiol, and eplerenone.
Liga nd
GRα
AR
P R ERα
MR
Re fere nce
2.03 ×10
-
9
4.96 ×1 0
-
1
0
6.27 ×1 0
-
1
0
6.94 ×1 0
-
9
1. 4
YJH08 4 01 ×102 20 ×1 05 55×1 01 90 ×1 02
K
d
(M)
Figure 3. Radiosynthesis of 11C-YJH08. A schema 
showing the conditions for the methylation reaction. 
This simple radiochemistry was consistently high 
yielding, and is readily adaptable for human dose 
preparation. 

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Phase I – 11C-YJH08
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We next performed treatment studies to demonstrate that 11C-YJH08 accumulation in tissues is 
due to specific GR binding. Wild type C57Bl6/J mice were treated with the synthetic agonist 
dexamethasone via oral gavage for three days to occupy the ligand binding domain on GR, 
which in turn suppressed 11C-YJH08 uptake in nearly every normal tissue (Figure 4A).  
Moreover, 11C-YJH08 uptake in tissues was significantly higher in adrenalectomized mice 
compared to intact mice, consistent with a GR dependent mechanism of action (Figure 4B). 
Collectively, these data underscore that 11C-YJH08 binds GR in vivo, and show that 11C-YJH08 
can measure GR occupancy by endogenous or synthetic ligands. 
We next conducted a pilot study to test if 11C-YJH08 can detect a PC3 tumor in vivo.  PC3 
tumors embedded in the renal capsule took up very high levels of 11C-YJH08 (Figure 5A).  
Radiotracer uptake (~3% ID/g) was significantly higher in the tumor compared to GR rich 
tissues like the brain and lungs.  Moreover, the radiotracer uptake was significantly higher than 
what was observed in bone, further underscoring the clinical utility of the radioligand.  Lastly, 
digital autoradiography of the affected kidney was applied to define relative uptake of the 
radiotracer in the tumor and normal kidney parenchyma (Figure 5B and 5C).  The radiotracer 
uptake in the tumor was qualitatively much higher than the level observed in the kidney. These 
early data suggest that 11C-YJH08 could be a useful tool for measuring GR expression in 
mCRPC.
The rodent dosimetry was recently performed at UCSF, and the estimated effective dose to an 
adult human male (73 kg) is 0.0067 mSv/MBq (Table 2).  This value shows that the radiotracer 
is very safe, and a dose of up to 20 mCi per scan is justifiable.  Using this funding mechanism, 
we are also performing single species rodent toxicity studies with Charles River Laboratories.  
Figure 4. In vivo blocking studies reveal that 11C-YJH08 specifically binds GR in vivo. A. Biodistribution data 
collected 20 min post-injection showing the suppression of 11C-YJH08 uptake in several mouse tissues by 
dexamethasone (Dex, n = 5/arm). Dex was administered via two routes involving oral gavage of 50 mg/kg for three 
days prior to radiotracer injection or administration of a water-soluble dexamethasone-cyclodextrin (CD) complex 
via intraperitoneal injection at 10 mg/kg one hour prior to radiotracer injection. *P<0.05. At right is shown the 
blocking data observed in the brain. *P<0.01 B. The percent changes in radiotracer uptake per tissue among mice 
exposed to dexamethasone or Dex-CD versus vehicle. C. Representative CT and PET/CT images showing the 
suppression of 11C-YJH08 binding in selected organs in vivo by Dex treatment.

UCSF Helen Diller Family Comprehensive Cancer Center
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Phase I – 11C-YJH08
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The radiotracer will be synthesized to GMP standards in the UCSF radiopharmacy, a FDA 
certified PET drug manufacturer. Anticipated timeline for IND submission is first quarter of 2021.
1.3Overall Study Rationale
The proposed patient studies represent the first-ever cancer patient imaging studies with 
11C-YJH08 PET.  The patient population for Cohort A is designed to determine the dosimetry 
of the imaging agent, and will enroll any solid tumor malignancy.  The patient population for 
Cohort B is designed to enrich for GR-overexpressing tumors, by selecting mCRPC patients 
at the time of progression by PCWG criteria on systemic therapies. And Cohort C is designed 
to include patients with any solid tumor malignancies other than prostate adenocarcinoma 
with one or more metastases on conventional imaging. Successful completion of the 
feasibility portion of the study (Cohort A) will provide the necessary preliminary data to 
support subsequent enrollment in Cohort B or C.  

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Table 2.  A summary of the mouse dosimetry data for (±)-11C-YJH08.  The values were 
calculated from a 90 min dynamic PET acquisition in intact male or female C57Bl6/J mice.
Organ
Absorbed Dose (mGy/MBq) or Equivalent Dose (mSv/MBq)
Adult male (73 kg)
Adult female (60 kg)
Figure 5. 11C-YJH08 detects a GR-rich PC3 tumor in 
the renal capsule. A. Ex vivo biodistribution data showing 
that radiotracer accumulation in the PC3 tumor is higher 
than the level observed in GR-rich tissues like the brain and 
lungs. Radiotracer uptake is also higher than the level 
observed in bone, suggesting the signal to noise in the PET 
assay may be substantial enough to detect mCRPC.B. 
Digital auto-radiography overlaid with H&E show the high 
uptake of the radiotracer in the PC3 tumor compared to the 
normal kidney. C. A higher magnification field of view 
shows the colocalization of high radiotracer uptake with the 
tumor.

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Phase I – 11C-YJH08
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Adrenals
0.00533 ± 0.000748
0.00578 ± 0.000156
Brain
0.00140 ± 0.000022
0.00229 ± 0.000078
Breasts
0.00286 ± 0.000129
Esophagus
0.00831 ± 0.004249
0.00544 ± 0.000439
Eyes
0.00194 ± 0.000092
0.00223 ± 0.000061
Gallbladder Wall
0.00602 ± 0.000876
0.00459 ± 0.000041
Left colon
0.00374 ± 0.000769
0.00437 ± 0.000314
Small Intestine
0.00325 ± 0.000446
0.00325 ± 0.000114
Stomach Wall
0.01628 ± 0.005962
0.01925 ± 0.002944
Right colon
0.00367 ± 0.000548
0.00339 ± 0.000070
Rectum
0.00249 ± 0.000093
0.00280 ± 0.000087
Heart Wall
0.06753 ± 0.050725
0.02570 ± 0.005677
Kidneys
0.00714 ± 0.000174
0.00785 ± 0.001344
Liver
0.01568 ± 0.001377
0.01863 ± 0.001258
Lungs
0.01350 ± 0.011132
0.00909 ± 0.000339
Pancreas
0.00665 ± 0.002374
0.00545 ± 0.000182
Ovaries
0.00288 ± 0.000090
Prostate
0.00250 ± 0.000105
Salivary Glands
0.00226 ± 0.000156
0.00241 ± 0.000068
Red Marrow
0.00310 ± 0.000771
0.00289 ± 0.000101
Osteogenic Cells
0.00223 ± 0.000391
0.00217 ± 0.000069
Spleen
0.00378 ± 0.000828
0.00432 ± 0.000300
Testes
0.00204 ± 0.000046
Thymus
0.01004 ± 0.005999
0.00498 ± 0.000454
Thyroid
0.00355 ± 0.001070
0.00297 ± 0.000118
Urinary Bladder Wall
0.00247 ± 0.000136
0.00288 ± 0.000114
Uterus
0.00284 ± 0.000085
Total Body
0.00355 ± 0.000856
0.00366 ± 0.000121
Effective Dose (mSv/MBq)
0.00673 ± 0.002757
0.00649 ± 0.000433
2
Study Objectives and Hypotheses
2.1Study Hypotheses
1.
Cohort A: 11C-YJH08 PET will demonstrate feasibility of uptake within one or 
more metastatic lesions. 
2.
Cohort B and C: 11C-YJH08 PET will detect metastatic lesions with high 
sensitivity using conventional imaging as a reference standard. 

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Phase I – 11C-YJH08
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2.2Primary Objectives
Primary Objective
Endpoint(s)
Time Frame
1. Cohort A: To determine the feasibility of 
metastatic lesion detection in using 11C-
YJH08 PET.
Cohort A: 
Sensitivity of 
metastatic lesion 
detection in using 
11C-YJH08 PET.
2 days
2. Cohort B and C: To determine the mean 
percent change from baseline at the time 
of progression on systemic therapy in 
SUVmax-ave on paired 11C-YJH08 PET on a 
per-patient and per-lesion basis.  
Cohort B and C: 
Mean percent 
change from 
baseline at the 
time of 
progression on 
systemic therapy 
in SUVmax-ave on 
paired 11C-YJH08 
PET on a per-
patient and per-
lesion basis. 
Baseline to 
time of 
progression

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2.3Secondary Objectives
Secondary Objective
Endpoint(s)
Time Frame
1. To determine the safety and determine 
average organ uptake of 11C-YJH08.
Safety as recorded 
by CTCAE v 5.0 
criteria and organ 
dosimetry of 11C-
YJH08 PET. 
2 days
2. 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. 
Descriptive 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 
will be assessed.
2 days
3. Cohort B and C: To determine whether 
baseline uptake on 11C-YJH08 PET is 
associated with subsequent clinical 
outcomes including objective response 
rate, progression-free survival, and 
PSA50 response. 
Association 
between baseline 
uptake on 11C-
YJH08 PET with 
subsequent clinical 
outcomes including 
objective response 
rate, progression-
free survival, and 
PSA50 response
Baseline to 
time of 
progression.

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2.4Exploratory Objective
Exploratory Objective
Endpoint(s)
1. To determine the association between uptake on 11C-
YJH08 PET with GR expression and transcriptional 
signature scores on paired metastatic tumor biopsies
Association between 
uptake on 11C-YJH08 
PET with GR 
expression by IHC 
and transcriptional 
signature scores on 
paired metastatic 
tumor biopsies
3
Study Design
3.1Characteristics
This is a first-in-human phase 1 imaging study of 11C-YJH08 PET in patients with advanced 
solid tumor malignancies.   
3.2Number of Subjects
Approximately 26 patients will be enrolled in one of the following cohorts: 
Cohort A (N = 6 patients): Patients with any solid tumor malignancy with evidence of one or 
more metastases on conventional imaging. 
Cohort B (N = 10 patients): Patients with metastatic CRPC will undergo 11C-YJH08 PET at the 
time of progression by PCWG3 criteria on systemic therapies. 
Cohort C (N = 10 patients): Patients with any solid tumor malignancies other than prostate 
adenocarcinoma with one or more metastases on conventional imaging will undergo 11C-
YJH08 PET at the time of progression.
Enrollment in Cohort B and C will be conducted after completion of enrollment in Cohort A. 
3.3Eligibility Criteria
Patients must have baseline evaluations performed within 28 days prior to the baseline 11C-
YJH08 PET, except for baseline conventional imaging which must be completed 12 weeks prior  
to and including baseline visit. Patients must meet all inclusion and exclusion criteria. In 
addition, the patient must be thoroughly informed about all aspects of the study, including the 
study visit schedule and required evaluations and all regulatory requirements for informed 
consent. The written informed consent must be obtained from the patient prior to enrollment. 
Once it has been ascertained that subjects are eligible for the study, their authorization to use 
personal health information for this study and their informed consent will be obtained. Each 
subject will be assigned a unique study identification number at the time of study enrollment in 
order to ensure confidentiality of study data. 
3.3.1 Inclusion Criteria
Subjects may be included in the study if they meet all of the following criteria:

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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 criteria.
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: 

Serum creatinine ≤ 1.5 x 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
3.3.2 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 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). 
3.4Study Timeline
3.4.1 Primary Completion
The estimated study period is approximately 36 months from the date of first patient enrolled.

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3.4.2 Study Termination
The principal investigator reserves the right to terminate the study at any time.
Termination of the study will be considered in the event of any safety concerns arising at any 
time during the performance of the study.
If it becomes necessary to consider termination of the study after dosing has begun, dosing may 
be suspended pending discussion between the investigators and the DSMC.
4
Investigational Medicinal Product
11C-YJH08 is a radiopharmaceutical that will be produced under cGMP in the Department of 
Radiology and Biomedical Imaging Radiopharmaceutical Facility. The radiopharmaceutical will 
be prepared in the same facility in which the injection and imaging will take place, the China 
Basin Imaging Center. 
11C-YJH08 will be administered on an outpatient basis. It will be administered intravenously prior 
to PET imaging. The injected dose will be approximately 20 mCi. Between 10-60 minutes 
following 11C-YJH08 injection, one or more whole body CT (PET/CT) or MRI (PET/MR) scans 
will be used for attenuation correction and anatomic localization of 11C-YJH08 and SUV 
calculation.
11C-YJH08 Injection is the IMP in this study.
5
Study Procedures and Schedules of Events
5.1Participant Registration
A written, signed, informed consent form (ICF) and a Health Insurance Portability and 
Accountability Act (HIPAA) authorization must be obtained before any study-specific 
assessments are initiated. A copy of the signed ICF will be given to the subject and a copy will 
be filed in the medical record. The original will be kept on file with the study records.
All participants consented to the study will be registered in OnCore®, the UCSF Helen Diller 
Family Comprehensive Cancer Center Clinical Trial Management System (CTMS). The system 
is password protected and meets HIPAA requirements.
A list of study subjects will be completed and will include each subject's study number and 
initials. The investigator must also maintain a separate log of all the subjects screened for 
participation in the study but who will not participate, the reasons for their exclusion or non- 
participation, their initials, and the date on which the subject was excluded.
5.2Schedule of Procedures and Assessments
5.2.1 Screening Assessments
The screening procedures and assessments must be completed within 28 days of baseline PET 
(PET/CT or PET/MR) scan except for staging scans which need to be completed 12 weeks prior 
to baseline PET. All screening procedures may be performed on the same day as baseline PET, 
provided screening and eligibility confirmation is completed and verified by Principal Investigator 
prior to initiation of PET. 

Baseline conditions

Vital signs including heart rate and blood pressure 

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
Concomitant medication review

AE assessment

Demographic information (e.g. age, race, height, weight, and body mass index)

Staging scans - cross-sectional imaging of the chest/abdomen/pelvis (CT or MRI; 
with IV contrast if medically permissible) within 12 weeks of baseline 11C-YJH08 
PET.

ECOG or Karnofsky Performance status

Laboratory procedures
o
Serum creatinine
o
Total bilirubin
o
Aspartate aminotransferase (AST)
o
Alanine aminotransferase (ALT)
o
Complete blood count + differential
o
Prostate-specific antigen (PSA)
o
Serum testosterone. Result may be pending at the time of completion of 
baseline PET provided documentation of ongoing LHRH analog treatment 
is available (see eligibility criteria above) 
5.2.2 Day 1, Baseline 11C-YJH08 PET
For cohort A (dosimetry calculation), multiple time points (up to 5 time points) will be obtained.  
Imaging will begin immediately after injection of radiotracer and continue up to ~90 minutes after 
injection of the radiopharmaceutical. From the 90 minutes of data collected, up to 5 time points 
will be selected, and reconstructions will be performed. For Cohorts B and C, one to two time 
point whole body PET/CT or PET/MR scans will be performed extending from the patient’s 
vertex through the thighs. Uptake time will be based on the initial results of Cohort A, though 
may be adjusted based on the data obtain during the study.  
The following procedures and assessments will be performed:

Imaging will begin immediately after injection of 11C-YJH08.
o
Cohort A imaging will be performed up to 5 time points
o
Cohorts B and C whole body PET/CT (or PET/MR) will be performed one or two 
times.

Vital signs including heart rate and blood pressure will be collected at screening, before 
and after administration of 11C-YJH08 injection, then at 60 minutes (+/- 15 min), and 2 
hours (+/- 30 min), following 11C-YJH08 injection.

Safety monitoring will include adverse event assessment during screening, 60 minutes 
(+/- 15 min), 2 hours (+/- 30 min) and 24 hours (+/- 4 hours) following 11C-YJH08 
injection. No iodinated contrast or gadolinium will be administered. 

Serum creatinine, total bilirubin, AST, ALT, and CBC + diff will be performed at 
screening and at 24 hours (+/- 4 hours) following 11C-YJH08 injection.

EKG/ECG will be performed prior to 11C-YJH08 injection (up to 4 hours prior) and at 2 
hours (+/- 30 min) following 11C-YJH08 injection.
No formal report of the findings from imaging studies will be created. Each scan will be reviewed 
by a board-certified nuclear medicine physician and radiologist within two working days of the 

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completion of the study. If any unexpected findings are visualized, these will be reported to the 
treating health care provider, who will then contact the patient if additional work-up needs to be 
performed. The reviewing nuclear medicine physician will be required to sign a written form 
indicating that they have reviewed the scan results and communicated any clinically pertinent 
findings to the treating physician within two business days of scan completion.
Baseline Tumor Biopsy (Optional)
Patients will undergo optional metastatic tumor biopsy within 14 days following completion of 
baseline PET scan. The biopsy sample will be analyzed for protein expression of GR by IHC 
and RNA-seq for application of GR transcriptional signature when sufficient tumor content is 
present. Soft tissue, PET-avid lesions will be prioritized for biopsy. 
5.2.3 OPTIONAL 11C-YJH08 PET at Progression (Cohorts B and C)
Patients will undergo optional repeat 11C-YJH08 PET at the time of progression by PCWG3 
criteria for Cohort B and RECIST 1.1 criteria for Cohort C. Patients who underwent PET/CT at 
baseline should have same imaging modality performed during follow-up, and likewise patients 
who underwent PET/MR at baseline should have same imaging modality performed during 
follow up.

Vital Signs

Concomitant medication review

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Period/
Procedure
Screening
(Day -28 thru C1D1)
Cycle 1, Day 1
(Baseline PET)
Disease 
Progression  
(Cohort B and C)
Study / Investigational Product Administration
11C-YJH08 PET
X
X
Administrative Procedures
Informed consent
X
Clinical Assessments
Baseline conditions
X
Vital signs1
X
X
X
Concomitant medications
X
X
AE assessment2
X
X
Demographics
X
Performance status
X
Laboratory Assessments
Serum creatinine, total bilirubin, AST, ALT, CBC + diff3
X
X
PSA, Serum Testosterone 
X
Imaging Procedures
Staging scans (CT or MRI)
X
ECG/EKG
X4
Tissue Collection/ Biopsy
Tumor biopsy (optional)5
X
1 Vital signs (blood pressure, heart rate) will be collected at screening, before and after administration of 11C-YJH08 injection, then at 60 minutes (+/- 15 min), and 
2 hours (+/- 30 min) following 11C-YJH08 injection.
2 Safety monitoring will include adverse event assessment at screening, 60 minutes (+/- 15 min), 2 hours (+/- 30 min) and 24 hours (+/- 4 hours) following 11C-
YJH08 injection.
3 Serum creatinine, total bilirubin, AST, ALT, and CBC + diff will be performed at screening and at 24 hours (+/- 4 hours) following 11C-YJH08 injection. 
4 EKG will be performed prior to 11C-YJH08 injection and at 2 hours (+/- 30 min) following 11C-YJH08 injection.
5 Metastatic tumor biopsy is optional. Tumor biopsy should be performed within 14 days following baseline PET. Soft tissue, PET-avid lesions should be prioritized 
for biopsy whenever feasible.

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Supportive Care
Subjects will receive full supportive care as medically indicated.
The Principal Investigator or designee will be present during the administration and monitoring 
period. Any events occurring during or subsequent to the administration of IMP will be 
addressed as required by the monitoring nurse and/or physician as deemed appropriate.
6
Reporting and Documentation of Results
6.1
Evaluation of Safety
Analyses will be performed for all patients having received at least one dose of IMP. The study 
will use the CTCAE v5.0 criteria for reporting of non-hematologic adverse events and modified 
criteria for hematologic adverse events.
6.2
Definitions of Adverse Events
6.2.1
Adverse Event
An adverse event (also known as an adverse experience) is defined as any untoward medical 
occurrence associated with the use of a drug in humans, whether or not considered drug 
related. More specifically, an adverse event (can be any unfavorable and unintended sign (e.g., 
an abnormal laboratory finding), symptom, or disease temporally associated with the use of a 
drug, without any judgment about causality. An adverse event can arise from any use of the 
drug (e.g., off-label use, use in combination with another drug) and from any route of 
administration, formulation, or dose, including an overdose.
Laboratory test value abnormalities will not be recorded as AEs unless they are designated as 
clinically significant, defined as any one of the following: symptomatic, requiring treatment, 
resulting in dose modification or delay or premature study withdrawal, or placing the subject at 
risk for other toxicity in the judgment of the treating investigator.
6.2.2
Adverse Reaction
An adverse reaction is defined as any adverse event caused by the use of a drug. Adverse 
reactions are a subset of all suspected adverse reactions for which there is reason to conclude 
that the drug caused the event.
6.2.3
Suspected Adverse Reaction 
A suspected adverse reaction is defined as any adverse event for which there is a reasonable 
possibility that the drug caused the adverse event. For the purposes of IND safety reporting, 
“reasonable possibility” indicates that there is evidence to suggest a causal relationship 
between the drug and the adverse event. A suspected adverse reaction implies a lesser degree 
of certainty about causality than an adverse reaction.
6.2.4
Unexpected 
An adverse event or suspected adverse reaction is considered unexpected if it is not listed in 
the investigator brochure or package insert(s), or is not listed at the specificity or severity that 
has been observed, or, if an investigator brochure is not required or available, is not consistent 
with the risk information described in the general investigational plan or elsewhere in the current 
application.

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“Unexpected,” as used in this definition, also refers to adverse events or suspected adverse 
reactions that are mentioned in the investigator brochure as occurring with a class of drugs or 
as anticipated from the pharmacological properties of the drug, but are not specifically 
mentioned as occurring with the particular drug under investigation.
Adverse events that would be anticipated to occur as part of the disease process are 
considered unexpected for the purposes of reporting because they would not be listed in the 
investigator brochure. For example, a certain number of non-acute deaths in a cancer trial 
would be anticipated as an outcome of the underlying disease, but such deaths would generally 
not be listed as a suspected adverse reaction in the investigator brochure.
Some adverse events are listed in the Investigator Brochure as occurring with the same class of 
drugs, or as anticipated from the pharmacological properties of the drug, even though they have 
not been observed with the drug under investigation. Such events would be considered 
unexpected until they have been observed with the drug under investigation. For example, 
although angioedema is anticipated to occur in some patients exposed to drugs in the ACE 
inhibitor class and angioedema would be described in the investigator brochure as a class 
effect, the first case of angioedema observed with the drug under investigation should be 
considered unexpected for reporting purposes.
6.2.5
Serious
An adverse event or suspected adverse reaction is considered serious if, in the view of either 
the investigator or sponsor, it results in any of the following outcomes:

Death

Life-threatening adverse event

Inpatient hospitalization or prolongation of existing hospitalization

A persistent or significant incapacity or substantial disruption of the 
ability to conduct normal life function

Congenital anomaly/birth defect

Cancer
Important medical events that may not result in death, are life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, 
they may jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in this definition. Examples of such medical events include 
allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood 
dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of 
drug dependency or drug abuse.
6.2.6
Serious
An adverse event or suspected adverse reaction is considered life-threatening if, in the view of 
either the investigator or sponsor, its occurrence places the patient or subject at immediate risk 
of death. It does not include an adverse event or suspected adverse reaction that, had it 
occurred in a more severe form, might have caused death.
6.3
Recording of an Adverse Event
All grade 3 and above adverse events will be entered into OnCore®, whether or not the event is 
believed to be associated with use of the IMP. Data about these events and their severity will be 
recorded using the NCI CTCAE v5.0.

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The Investigator will assign attribution of the possible association of the event with use of the 
investigational drug, and this information will be entered into OnCore® using the classification 
system listed below:
Relationship
Attribution
Description
Unrelated
The AE is clearly NOT related to 
the intervention
Unrelated to investigational 
drug/intervention
Unlikely
The AE is doubtfully related to 
the intervention
Possible
The AE may be related to the intervention
Probable
The AE is likely related to the intervention
Related to investigational 
drug/intervention
Definite
The AE is clearly related to the intervention
Signs or symptoms reported as adverse events will be graded and recorded by the Investigator 
according to the CTCAE. When specific adverse events are not listed in the CTCAE they will be 
graded by the Investigator as none, mild, moderate or severe according to the following grades 
and definitions:
Grade 0
No AE (or within normal limits)
Grade 1
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated
Grade 2
Moderate; minimal, local, or noninvasive intervention (e.g., packing, 
cautery) indicated; limiting age-appropriate instrumental activities of daily 
living (ADL)
Grade 3:
Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting 
self- care ADL
Grade 4:
Life-threatening consequences; urgent intervention indicated
Grade 5:
Death related to AE
6.4
Follow-up of Adverse Events
All adverse events will be followed with appropriate medical management until resolved. 
Patients removed from study for unacceptable adverse events will be followed until resolution or 
stabilization of the adverse event. For selected adverse events for which administration of the 
investigational drug was stopped, a re-challenge of the subject with the investigational drug may 
be conducted if considered both safe and ethical by the Investigator.
6.5
Adverse Events Monitoring
All adverse events, whether or not unexpected, and whether or not considered to be associated 
with the use of the IMP, will be entered into OnCore®, as noted above.
The Investigator will assess all adverse events and determine reportability requirements to the 
UCSF Data and Safety Monitoring Committee (DSMC) and UCSF’s Institutional Review Board; 
and, when the study is conducted under an Investigational New Drug Application (IND), to the 
Food and Drug Administration (FDA) if it meets the FDA reporting criteria.
All adverse events entered into OnCore® will be reviewed by the Helen Diller Family 
Comprehensive Cancer Center Site Committee on a weekly basis. The Site Committee will 

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review and discuss at each weekly meeting the selected toxicity, the toxicity grade, and the 
attribution of relationship of the adverse event to the administration of the IMP(s).
In addition, all adverse events and suspected adverse reactions considered “serious,” entered 
into OnCore® will be reviewed and monitored by the Data and Safety Monitoring Committee on 
an ongoing basis, discussed at DSMC meetings which take place every six (6) weeks. For a 
detailed description of the Data and Safety Monitoring Plan. 
6.6
Expedited Reporting
6.6.1
Reporting to the Data and Safety Monitoring Committee
If a death occurs during the treatment phase of the study or within 30 days after the last 
administration of the IMP(s) and it is determined to be related either to the IMP(s) or to a study 
procedure, the Investigator or his/her designee must notify the DSMC Chair (or qualified 
alternate) within 1 business day of knowledge of the event. The contact may be by phone or e- 
mail.
6.6.2
Reporting to UCSF Institutional Review Board
The Principal Investigator must report events meeting the UCSF IRB definition of “Unanticipated 
Problem” (UP) within 10 business days of his/her awareness of the event.
6.6.3
Expedited Reporting to the Food and Drug Administration
The Sponsor-Investigator is responsible for determining whether or not the suspected adverse 
reaction meets the criteria for expedited reporting in accordance with Federal Regulations (21 
CFR §312.32).
The Investigator must report in an IND safety report any suspected adverse reaction that is both 
serious and unexpected. The Sponsor-Investigator needs to ensure that the event meets all 
three definitions:

Suspected adverse reaction

Unexpected

Serious
If the adverse event does not meet all three of the definitions, it should not be submitted as an 
expedited IND safety report.
The timeline for submitting an IND safety report to FDA is no later than 15 calendar days after 
the Investigator determines that the suspected adverse reaction qualifies for reporting (21 CFR 
312.32(c)(1)).
Any unexpected fatal or life-threatening suspected adverse reaction will be reported to FDA no 
later than 7 calendar days after the Investigator’s initial receipt of the information (21 CFR 
312.32(c)(2)).
Any relevant additional information that pertains to a previously submitted IND safety report will 
be submitted to FDA as a Follow-up IND Safety Report without delay, as soon as the 
information is available (21 CFR 312.32(d)(2)).

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7
Statistical Analysis
7.1
Imaging Analysis
A trained nuclear medicine physician will evaluate the reconstructed PET, CT or MRI, and fused 
PET/CT or PET/MR images using a PET volume computer-assisted reading software package. 
A positive lesion on PET will be defined as a focus of activity with at least 1.5 times higher SUV 
compared with mediastinal blood pool that is not attributable to other etiologies of tracer 
distribution (e.g. inflammation, excretion). A volume of interest (VOI) will be semiautomatically 
placed around each lesion, and the calculated maximum standard uptake value (SUVmax) will be 
recorded for each lesion, including lesions that are detected on standard scans but are not 
positive on PET. Adjusted SUVmax data will then be averaged across all lesions within a given 
patient (SUVmax-avg). In order to avoid clustering effects, analysis will be limited to the five largest 
osseous metastases and all visceral/soft tissue metastases.
.
7.2
Determination of Sample Size
A convenience sample size of approximately 6 patients for Cohort A is selected to collect 
sufficient scan data to ensure adequate organ dosimetry and determination of the optimal 
uptake time following administration of 11C-YJH08. Additional patients may be accrued as 
necessary to optimize imaging acquisition parameters prior to proceeding to Cohort B and C 
enrollment. 
Success for Cohort A will be defined as technically successful injection of radiotracer with 
expected biodistribution and visualization of radiotracer uptake in the expected location of a 
metastasis based on conventional imaging in at least one patient. If no metastases are 
visualized despite varying uptake time and injected dose after 6 or more patients are enrolled in 
Cohort A, then accrual will not proceed to Cohorts B and C. 
For patients enrolled in Cohorts B and C, a convenience sample size of 10 evaluable patients 
per cohort is chosen to provide preliminary estimates of sensitivity of lesion detection on PET 
compared to conventional imaging.  We expect 20% inevaluable rate over the course of the 
study; we will recruit 12 patients in each cohort to achieve the target sample size.
7.3
Subject Characteristics
Demographic information (e.g., age, race, height, weight, and body mass index) will be 
summarized using descriptive statistics.
Concurrent medications will be recorded and coded using a standard classification system.
Disease factors for subjects accrued to the study will be characterized using descriptive 
statistics.
7.4
Replacement Policy
Patients may be replaced for the following reasons:

Inability to tolerate/complete baseline PET

Sub-optimal timing of post-injection PET scan compromising ability to detect 
metastatic lesions

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7.5
Accrual estimates
The estimated accrual period is approximately 36 months. 
7.6
Interim Analysis
An interim analysis for safety will be performed after 6 patients have enrolled to Cohort A. If 
more than 33% of patients experience a Grade ≥ 2 related adverse event, study accrual will be 
halted and alternative dose levels may be explored. 
An informal analysis to confirm feasibility will be performed after approximately 6 patients are 
enrolled on Cohort A. Images will be qualitatively reviewed and preliminary data with respect to 
signal-to-noise ratio within metastatic lesions will be assessed by body site. If it is determined 
that insufficient signal- to-noise ratio is present, additional patients may be accrued in Cohort A 
with proper technological adjustments (e.g. timing of post-injection scan acquisition, injected 
dose of radiotracer) to ensure optimal intra-tumoral uptake of tracer before proceeding to Cohort 
B and C enrollment. 
7.7
Analytic Plan
7.7.1
Analysis Population
All data from all subjects dosed in the study will be included in all listings, plots, summary tables, 
and statistical analyses when appropriate. Missing values will not be substituted by estimated 
values, but treated as missing in the statistical evaluation.
7.7.2
Primary Analysis
For Cohort A, 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 of 11C-YJH08 PET will be 
descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans 
including CT or MRI of the chest/abdomen/pelvis. 
 
For Cohorts B and C, the median percent change from baseline, and range of SUVmax (across 
all metastatic lesions per patient) and SUVmax-ave (in each study cohort) will be descriptively 
reported using mediastinal blood pool and normal organ as background uptake values. 
Wilcoxon signed rank test will be used to compare the follow up to baseline PET scan values at 
lesion level and patient level. 
7.7.3
Analysis of Secondary and Exploratory Endpoints
The frequency and severity of adverse events following 11C-YJH08 injection will be 
descriptively reported, using CTCAE v 5.0. Organ dosimetry on PET will be calculated using 
standard technique.
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. 
For the purposes of analyzing the association between baseline and percent change from 
baseline in SUVmax-ave with subsequent clinical outcomes, the cohort will be dichotomized above 
and below the median for the study cohort.  The PSA response rate (PCWG3 criteria; Cohort B 
only), clinical benefit rate, and objective response rate (in subset of measurable tumors by 
RECIST 1.1) will be compared between dichotomized groups using the chi-squared test. The 

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log rank test will be used to compare progression-free survival between dichotomized 
subgroups. 
For patients who undergo optional tumor biopsy with evaluable tumor content, the correlation 
between SUVmax of the target lesion on PET with GR expression by IHC (using H-score method) 
will computed using Pearson correlation method. Likewise, the correlation between SUVmax on 
PET with GR transcriptional signature activity by RNA-seq will be determined using Pearson 
correlation method when sufficient tumor content permits transcriptional analysis.
No adjustment will be made for multiple comparisons for the analysis of the secondary and 
exploratory endpoints.
8
Study Management
8.1
Pre-study Documentation
This study will be conducted in accordance with the ethical principles that have their origin in the 
Declaration of Helsinki as stated in 21 CFR §312.120(c)(4); consistent with GCP and all 
applicable regulatory requirements.
Before initiating this trial, the Investigator will have written and dated approval from the 
Institutional Review Board for the protocol, written informed consent form, subject recruitment 
materials, and any other written information to be provided to subjects before any protocol 
related procedures are performed on any subjects.
The Investigator must comply with the applicable regulations in Title 21 of the Code of Federal 
Regulations (21 CFR §50, §54, and §312), GCP/ICH guidelines, and all applicable regulatory 
requirements. The IRB must comply with the regulations in 21 CFR §56 and applicable 
regulatory requirements.
The clinical investigation will not begin until either FDA has determined that the study under the 
Investigational Drug Application (IND) is allowed to proceed, or the Investigator has received a 
letter from FDA stating that the study is exempt from IND requirements.
8.2
Institutional Review Board Approval
The protocol, the proposed informed consent form, and all forms of participant information 
related to the study (e.g. advertisements used to recruit participants) will be reviewed and 
approved by the UCSF IRB. Prior to obtaining IRB approval, the protocol must be approved by 
the Helen Diller Family Comprehensive Cancer Center Site Committee and by the Protocol 
Review Committee (PRC). The initial protocol and all protocol amendments must be approved 
by the IRB prior to implementation.
8.3
Informed Consent
All participants must be provided a consent form describing the study with sufficient information 
for each participant to make an informed decision regarding their participation. Participants must 
sign the IRB-approved informed consent form prior to participation in any study specific 
procedure. The participant must receive a copy of the signed and dated consent document. The 
original signed copy of the consent document must be retained in the medical record or 
research file.

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8.4
Changes in the Protocol
Once the protocol has been approved by the UCSF IRB, any changes to the protocol must be 
documented in the form of an amendment. The amendment must be signed by the Investigator 
and approved by PRC and the IRB prior to implementation.
If it becomes necessary to alter the protocol to eliminate an immediate hazard to patients, an 
amendment may be implemented prior to IRB approval. In this circumstance, however, the 
Investigator must then notify the IRB according to institutional requirements. 
8.5
Handling and Documentation of Clinical Supplies
The Principal Investigator will maintain complete records showing the receipt, dispensation, 
return, or other disposition of all investigational drugs. The date, quantity and batch or code 
number of the drug, and the identification of patients to whom IMP has been dispensed by 
patient number and initials will be included. The sponsor- investigator will maintain written 
records of any disposition of the IMP. 
The Principal Investigator shall not make the investigational drug available to any individuals 
other than to qualified study patients. Furthermore, the Principal Investigator will not allow the 
investigational drug to be used in any manner other than that specified in this protocol.
8.6
Case Report Forms (CRFs)
The Principal Investigator and/or his/her designee will prepare and maintain adequate and 
accurate participant case histories with observations and data pertinent to the study. Study 
specific Case Report Forms (CRFs) will document safety and treatment outcomes for safety 
monitoring and data analysis. The Clinical Research Coordinator (CRC) will complete the CRFs 
as soon as possible upon completion of the study visit; the Investigator will review and approve 
the completed CRFs.
The information collected on CRFs shall be identical to that appearing in original source 
documents. Source documents will be found in the patient’s medical records maintained by 
UCSF personnel. All source documentation should be kept in separate research folders for each 
patient.
In accordance with federal regulations, the Principal Investigator is responsible for the accuracy 
and authenticity of all clinical and laboratory data entered onto CRFs. The PI will approve all 
completed CRFs to attest that the information contained on the CRFs is true and accurate.
The Principal Investigator will be responsible for ensuring the accurate capture of study data. At 
study completion, when the CRFs have been declared to be complete and accurate, the 
database will be locked. Any changes to the data entered into the CRFs after that time can only 
be made by joint written agreement among the Study Chair, the Trial Statistician, and the 
Protocol Project Manager.
All source documentation and CTMS data will be available for review/monitoring by the UCSF 
DSMC and regulatory agencies.
8.7
Oversight and Monitoring Plan
The UCSF Helen Diller Family Comprehensive Cancer Center DSMC will be the monitoring 
entity for this study. The UCSF DSMC will monitor the study in accordance with the NCI- 
approved Data and Safety Monitoring Plan (DSMP). The DSMC will routinely review all adverse 
events and suspected adverse reactions considered “serious”. The DSMC will audit study- 

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related activities to ensure that the study is conducted in accordance with the protocol, local 
standard operating procedures, FDA regulations, and Good Clinical Practice (GCP). Significant 
results of the DSMC audit will be communicated to the IRB and the appropriate regulatory 
authorities at the time of continuing review, or in an expedited fashion, as applicable. Appendix 
2 – Data and Safety Monitoring Plan.
8.8
Record Keeping and Record Retention
The Principal Investigator is required to maintain adequate records of the disposition of the 
drug, including dates, quantity, and use by subjects, as well as written records of the disposition 
of the drug when the study ends.
The Principal Investigator is required to prepare and maintain adequate and accurate case 
histories that record all observations and other data pertinent to the investigation on each 
individual administered the investigational drug or employed as a control in the investigation. 
Case histories include the case report forms and supporting data including, for example, signed 
and dated consent forms and medical records including, for example, progress notes of the 
physician, the individual's hospital chart(s), and the nurses' notes. The case history for each 
individual shall document that informed consent was obtained prior to participation in the study.
Study documentation includes all CRFs, data correction forms or queries, source documents, 
Sponsor-Investigator correspondence, monitoring logs/letters, and regulatory documents (e.g., 
protocol and amendments, IRB correspondence and approval, signed patient consent forms).
Source documents include all recordings of observations or notations of clinical activities and all 
reports and records necessary for the evaluation and reconstruction of the clinical research 
study.
In accordance with FDA regulations, the Principal Investigator shall retain records for a period of 
2 years following the date a marketing application is approved for the drug for the indication for 
which it is being investigated; or, if no application is to be filed or if the application is not 
approved for such indication, until 2 years after the investigation is discontinued and FDA is 
notified.

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9
References
1.
Boudadi, K. & Antonarakis, E. S. Resistance to Novel Antiandrogen Therapies in 
Metastatic Castration-Resistant Prostate Cancer. Clinical Medicine Insights. Oncology 
10, 1-9, doi:10.4137/CMO.S34534 (2016).
2.
Arora, V. K. et al. Glucocorticoid receptor confers resistance to antiandrogens by 
bypassing androgen receptor blockade. Cell 155, 1309-1322, 
doi:10.1016/j.cell.2013.11.012 (2013).
3.
Li, J. et al. Aberrant corticosteroid metabolism in tumor cells enables GR takeover in 
enzalutamide resistant prostate cancer. eLife 6, doi:10.7554/eLife.20183 (2017).
4.
Isikbay, M. et al. Glucocorticoid receptor activity contributes to resistance to androgen-
targeted therapy in prostate cancer. Hormones & cancer 5, 72-89, doi:10.1007/s12672-
014-0173-2 (2014).
5.
Shah, N. et al. Regulation of the glucocorticoid receptor via a BET-dependent enhancer 
drives antiandrogen resistance in prostate cancer. eLife 6, doi:10.7554/eLife.27861 
(2017).
6.
Kach, J. et al. Selective Glucocorticoid Receptor Modulators (SGRMs) Delay Castrate-
Resistant Prostate Cancer Growth. Molecular cancer therapeutics 16, 1680-1692, 
doi:10.1158/1535-7163.MCT-16-0923 (2017).
7.
Puhr, M. et al. The Glucocorticoid Receptor Is a Key Player for Prostate Cancer Cell 
Survival and a Target for Improved Antiandrogen Therapy. Clinical cancer research : an 
official journal of the American Association for Cancer Research 24, 927-938, 
doi:10.1158/1078-0432.CCR-17-0989 (2018).
8.
Rew, Y. et al. Discovery of a Potent and Selective Steroidal Glucocorticoid Receptor 
Antagonist (ORIC-101). Journal of medicinal chemistry 61, 7767-7784, 
doi:10.1021/acs.jmedchem.8b00743 (2018).
9.
Wu, M. et al. Rational drug design for androgen receptor and glucocorticoids receptor 
dual antagonist. European journal of medicinal chemistry 166, 232-242, 
doi:10.1016/j.ejmech.2019.01.036 (2019).
10. Truillet, C. et al. Measuring glucocorticoid receptor expression in vivo with PET. 
Oncotarget 9, 20399-20408, doi:10.18632/oncotarget.24911 (2018).
11. Fairclough, M. et al. The automated radiosynthesis and purification of the opioid 
receptor antagonist, [6-O-methyl-11C]diprenorphine on the GE TRACERlab FXFE 
radiochemistry module. Journal of labelled compounds & radiopharmaceuticals 57, 388-
396, doi:10.1002/jlcr.3194 (2014).
12. Lee, R. A., Harris, C. A. & Wang, J. C. Glucocorticoid Receptor and Adipocyte Biology. 
Nuclear receptor research 5, doi:10.32527/2018/101373 (2018).
13. Carrasquillo, J. A. et al. Effect of antibody dose on the imaging and biodistribution of 
indium-111 9.2.27 anti-melanoma monoclonal antibody. Journal of nuclear medicine : 
official publication, Society of Nuclear Medicine 29, 39-47 (1988).

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14. Scheinin, N. M. et al. Biodistribution and radiation dosimetry of the amyloid imaging 
agent 11C-PIB in humans. Journal of nuclear medicine: official publication, Society of 
Nuclear Medicine 48, 128-133 (2007). 

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Appendix 1 Performance Status Criteria
ECOG Performance Status Scale
Karnofsky Performance Scale
Grade
Descriptions
Percent
Description
100
Normal, no complaints, no evidence 
of disease
0
Normal activity
Fully active, able to carry on all 
pre-disease performance 
without restriction
90
Able to carry on normal activity; 
minor signs or symptoms of disease
80
Normal activity with effort; some 
signs or symptoms of disease
1
Symptoms, but ambulatory
Restricted in physically 
strenuous activity, but 
ambulatory and able to carry out 
work of a light or sedentary 
nature (e.g., light housework, 
office work)
70
Cares for self, unable to carry on 
normal activity or to do active work
60
Requires occasional assistance, but 
is able to care for most of his/her 
needs
2
In bed < 50% of the time
Ambulatory and capable of all 
self-care, but unable to carry out 
any work activities
Up and about more than 50% of 
waking hours
50
Requires considerable assistance 
and frequent medical care
40
Disabled, requires special care and 
assistance
3
In bed > 50% of the time
Capable of only limited self-
care, confined to bed or chair 
more than 50% of waking hours
30
Severely disabled, hospitalization 
indicated
Death not imminent
20
Very sick, hospitalization indicated
Death not imminent
4
100% bedridden
Completely disabled
Cannot carry on any self-care
Totally confined to bed or chair
10
Moribund, fatal processes 
progressing rapidly
5
Dead
0
Dead

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Appendix 2 Data and Safety Monitoring Plan for a Non-therapeutic Institutional 
Trial
1.
Oversight and Monitoring Plan
The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) Data and Safety 
Monitoring Committee (DSMC) is responsible for monitoring data quality and participant 
safety for all HDFCCC institutional clinical trials. A summary of DSMC activities for this trial 
includes:

Annual auditing

Review of serious adverse events

Minimum of biennial regulatory auditing
The UCSF HDFCCC Data and Safety Monitoring Committee (DSMC) is responsible for 
participant safety for all HDFCCC institutional clinical trials. Greater than minimal risk 
nontherapeutic studies are characterized as low risk studies due to the trial design, as there 
isn’t administration of drugs or complementary therapy that puts the participants at 
significant risk.
2.
Monitoring and Reporting Guidelines
Investigators will conduct a continuous review of data and participant safety at monthly site 
committee meetings where the status of each participant is discussed and documented in 
the site committee minutes.
For “greater than minimal risk” nontherapeutic trials, the assigned DSMC Senior 
Monitor/Auditor will audit three of the enrolled participants once per year, with a maximum of 
ten participant charts audited during the entire course of auditing this trial until IRB closure.
After completion of each auditing visit, the DSMC Monitor/Auditors will send a follow-up 
report to the study team within 20 business days after the auditing visit is complete for the PI 
and the study team to resolve all action items from this report within 20 business days. An 
abbreviated regulatory review (i.e., reviewing protocol and consent versions, SAEs, PVs, 
DOA logs, 1572 forms, etc.) will occur at each participant monitoring review; however, a full 
regulatory review will occur on a biennially basis by the DSMC for regulatory compliance.
Auditing of all enrolled participants in these trials will be complete after 10 enrolled 
participants have been audited. However, regulatory reviews of the trial, safety reviews (i.e., 
Serious Adverse Event (SAE) reviews and Protocol Violation (PV) reviews), and 
audit/inspection preparation (as applicable) will continue until the trial is closed by the IRB.
3.
Review and Oversight Requirements
3.1
Adverse Event Monitoring
All Grade 3-5 adverse events (AEs), whether or not considered expected or unexpected 
and whether or not considered associated with the study intervention or procedure, will 
be entered into OnCore®, UCSF’s Clinical Trial Management System.
Adverse events are graded according to the Common Terminology Criteria for Adverse 
Events (CTCAE) as developed and revised by the Common Therapy Evaluation 
Program (CTEP) of the National Cancer Institute. Adverse events are further given an 

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assignment of attribution or relationship to study intervention or procedure. Attribution 
categories are:

Definite – The adverse event is clearly related to the study intervention or 
procedure.

Probable – The adverse event is likely related to study intervention or procedure.

Possible – The adverse event may be related to study intervention or procedure.

Unrelated – the adverse event is clearly not related to the study intervention or 
procedure.
All clinically significant adverse events entered into OnCore® will be reviewed on a 
monthly basis at the Site Committee meetings.
3.2
Serious Adverse Event Reporting
By definition, an adverse event is defined as a serious adverse event (SAE) according to 
the following criteria:

Death,

Life-threatening adverse experience*,

Inpatient hospitalization or prolongation of existing hospitalization,

Persistent or significant disability/incapacity,

Congenital anomaly/birth defect, or cancer, or 

Any other experience that suggests a significant hazard, contraindication, side 
effect, or precaution that may require medical or surgical intervention to prevent 
one of the outcomes listed above,

Event that changes the risk/benefit ratio of a study.
*A life-threatening adverse experience is any AE that places the patient or subject, in the 
view of the investigator, at immediate risk of death from the reaction as it occurred, i.e., it 
does not include a reaction that, had it occurred in a more severe form, might have 
caused death.
Serious adverse event reporting will be in accordance with all IRB regulations. For trials 
conducted under an investigational new drug (IND) application, the SAE will be reported 
in accordance with Code of Federal Regulation Title 21 Part 312.32 and will be reported 
on a Med Watch form.
UCSF IRB website for guidance in reporting serious adverse events:
https://irb.ucsf.edu/adverse-event 
Med Watch forms and information:
www.fda.gov/medwatch/getforms.htm 
All serious adverse events are entered into OnCore®, as well as submitted to the IRB. 
The SAEs are reviewed and monitored by the Data and Safety Monitoring Committee on 
an ongoing basis and discussed at DSMC meetings, which take place every six weeks. 

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The date the SAE was sent to all required reporting agencies will be documented in 
OnCore.
If a death occurs during the treatment phase of the study and is determined to be 
possibly, probably, or definitely related either to the study intervention or procedure, the 
Investigator or his/her designee must notify the DSMC Chair or Vice Chair and DSMC 
Director within one business day.
3.3
Review of Adverse Event Rates
If at any time the Investigator voluntarily holds enrollment or stops the study due to 
safety issues, the DSMC Chair (or Vice Chair) and the DSMC Director must be notified 
within one business day and the IRB must be notified as per IRB reporting requirements.
Data and Safety Monitoring Committee Contacts:
Katie Kelley, MD (DSMC Chair)
UCSF HDFCCC
San Francisco, CA 94158
John McAdams (DSMC Director)
UCSF HDFCCC
San Francisco, CA 94143
Research Study Monitor Contact: 
Melody Gawliu, (Sr. Data Safety Monitor)
UCSF HDFCCC
San Francisco, CA 94143