Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors
Phase: PHASE2
Conditions: Solid Tumor, Adult
Sponsor: CytoDyn, Inc.

 
 
CytoDyn Inc.    1111 Main Street, Suite 660, Vancouver, Washington 98660   T 360.980.8524  F 360.799.5954 
 
 
Protocol Cover Page 
 
 
Protocol Title: Basket Study of Leronlimab (PRO 140) in Patients with CCR5+ Locally Advanced 
or Metastatic Solid Tumors 
 
Protocol Number: CD09_Basket 
 
Version: 2.0 
 
Document Date: 14-May-2020 
 
NCT Number: NCT04504942 
 

CONFIDENTIAL
Page 1 of 117
Basket Study of Leronlimab (PRO 140) in Patients with CCR5+ Locally 
Advanced or Metastatic Solid Tumors
Protocol Number:
CD09_Basket
Version:
2.0
Date:
14-May-2020
Sponsor:
CytoDyn, Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
(360) 980-8524-Work
(360) 980-8549-Fax
www.cytodyn.com
Confidentiality Statement
This document is a confidential communication of CytoDyn, Inc. It is provided for the conduct of a
clinical research study. The information contained in this document is confidential and, except to the 
extent necessary to obtain informed consent or IEC/IRB approval, cannot be disclosed unless required by 
governmental regulation. Persons to whom any portion of the contents of this document is disclosed must 
be informed that the information is confidential and may not be further disclosed by them.

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PROTOCOL APPROVAL PAGE
Protocol Number:
CD09_Basket
Version:
2.0
Date:
14-May-2020
We, the undersigned, have reviewed this protocol and agree that it contains all relevant information 
required to meet FDA, GCP and all applicable regulatory guidelines and statutes.
PROTOCOL APPROVAL FOR USE

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INVESTIGATOR’S SIGNATURE PAGE
Protocol Number:
CD09_Basket
Version:
2.0
Date:
14-May-2020
I have read the protocol specified above and agree to participate in and comply with the procedures, as 
outlined herein for the conduct of this clinical trial. I also agree to comply with US Food and Drug 
Administration (FDA) regulations and Investigational Review Board/Institutional Ethics (IRB/IEC)
requirements for testing on human subjects. I agree to ensure that the requirements for obtaining informed 
consent are met.
Principal Investigator’s Signature
Date
Print Name
Site Number

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SPONSOR INFORMATION
CytoDyn, Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
(360) 980-8524-Work
(360) 980-8549-Fax
www.cytodyn.com
CONTRACT RESEARCH ORGANIZATION INFORMATION

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TABLE OF CONTENTS
PROTOCOL SYNOPSIS..............................................................................................................5
TABLE OF CONTENTS ............................................................................................................12
List of Tables.................................................................................................................................18
List of Figures ...............................................................................................................................19
List of Abbreviations.....................................................................................................................20
1
INTRODUCTION AND BACKGROUND .........................................................................23
1.1
Statement of Intent ..............................................................................................................23
1.2
Background of the Disease..................................................................................................23
1.2.1.
C-C Chemokine Receptor Type-5 (CCR5) .......................................................23
1.2.2.
Circulating Tumor Cells (CTCs).......................................................................26
1.2.3.
CCR5+ Tumor-Infiltrating Leukocytes.............................................................27
1.3
Study Treatments.................................................................................................................29
1.3.1.
Leronlimab (PRO 140)......................................................................................29
1.4
Pre-Clinical Studies of leronlimab (PRO 140)....................................................................30
1.4.1.
Effect of PRO140 on human CCR5 in breast cancer cells, MDA-MB-231......31
1.4.1.1
PRO140 binding to human CCR5 in human breast cancer cells.......................31
1.4.1.2
PRO140 blocks human CCR5 mediated signaling in human breast cancer cells.32
1.4.1.3
PRO140 blocks human CCR5 mediated invasion of extracellular matrix in 
human breast cancer cells..................................................................................32
1.4.2.
Effect of PRO 140 on Growth of SW480 Human Colon Carcinoma Xenografts34
1.4.3.
Clinical Studies with leronlimab (PRO 140).....................................................37
1.4.4.
PRO 140 1101 Study.........................................................................................37
1.4.5.
PRO 140 1102 Study.........................................................................................37
1.4.6.
PRO 140 1103 Study.........................................................................................38
1.4.7.
PRO 140 1302 Study.........................................................................................38
1.4.8.
PRO 140 2301 Study.........................................................................................38
1.4.9.
PRO 140 2101 Study.........................................................................................39
1.4.10.
PRO 140_CD01 Study ......................................................................................39
1.4.11.
PRO 140_CD01 Extension Study .....................................................................40
1.4.12.
PRO 140_CD02 Study ......................................................................................41

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1.4.13.
PRO 140_CD02 Extension Study .....................................................................42
1.4.14.
PRO 140_CD03 HIV Study..............................................................................42
1.4.15.
PRO 140_CD03 HIV Extension Study.............................................................43
1.4.16.
PRO 140_CD06 Study ......................................................................................43
1.4.17.
PRO 140_CD07 Study ......................................................................................43
1.4.18.
CD08_mCRC Study..........................................................................................43
1.4.19.
CD07_Compassionate Use................................................................................44
1.5
Dose Rationale ....................................................................................................................47
1.6
Risks / Benefits Assessment................................................................................................47
1.6.1.
Risks/Discomfort to Subjects and Precautions to Minimize Risk.....................47
1.6.2.
Intended Benefit for Subjects............................................................................49
2
STUDY OBJECTIVES..........................................................................................................50
3
STUDY DESIGN....................................................................................................................51
3.1
Study Center........................................................................................................................52
3.2
Study Population .................................................................................................................52
3.3
Eligibility Criteria................................................................................................................52
3.3.1.
Inclusion Criteria...............................................................................................52
3.3.2.
Exclusion Criteria..............................................................................................54
4
STUDY SCHEDULE.............................................................................................................55
4.1
Pre-Screening Period...........................................................................................................61
4.1.1.
Pre-Screening Visit............................................................................................61
4.2
Screening Period..................................................................................................................62
4.2.1.
Screening Visit (SV) .........................................................................................62
4.3
Treatment Period .................................................................................................................63
4.3.1.
Treatment Period, T1 (Week 1).........................................................................63
4.3.2.
Treatment Period, T2 (Week 2) Onward...........................................................64
4.4
Follow-Up Period................................................................................................................65
4.4.1.
End of Treatment Visit (EOT)...........................................................................65
4.4.2.
Survival Follow-up Visits .................................................................................66
4.5
Unscheduled Visits..............................................................................................................67

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5
SUBJECT COMPLETION, WITHDRAWAL AND CRITERIA FOR STOPPING THE
STUDY....................................................................................................................................68
5.1
Removal of Subjects from Study Treatment and/or Study as a Whole...............................68
5.2
Data Collected from Withdrawn Subjects...........................................................................69
5.3
Screen Failures ....................................................................................................................69
6
STUDY TREATMENT .........................................................................................................70
6.1
leronlimab (PRO 140) .........................................................................................................70
6.1.1.
Leronlimab (PRO 140) - Packaging and Labeling............................................70
6.1.2.
Leronlimab (PRO 140) - Storage and Handling................................................72
6.1.3.
Leronlimab (PRO 140) - Administration ..........................................................72
6.1.4.
Leronlimab (PRO 140) - Post Injection Monitoring .........................................73
6.1.5.
Leronlimab (PRO 140) - Dose Modifications...................................................73
6.1.6.
Leronlimab (PRO 140) - Disposition................................................................74
6.1.7.
Leronlimab (PRO 140) - Accountability...........................................................74
6.1.8.
Return and Retention of Study Drug.................................................................74
7
DESCRIPTION OF PROTOCOL ASSESSMENTS AND PROCEDURES ...................75
7.1
Informed Consent................................................................................................................75
7.2
Assessment of Eligibility.....................................................................................................75
7.2.1.
Re-screening......................................................................................................75
7.3
Demographic Information and Baseline Disease Characteristics .......................................75
7.4
Medical History...................................................................................................................76
7.5
Concomitant Medication .....................................................................................................77
7.5.1.
Permitted Medications.......................................................................................77
7.5.2.
Prohibited Medications......................................................................................77
7.6
Vital Signs, Height and Weight...........................................................................................78
7.7
Physical Examination..........................................................................................................78
7.8
ECOG Performance Status..................................................................................................78
7.9
Electrocardiogram (ECG)....................................................................................................79
7.10 Toxicity Assessment............................................................................................................79
7.11 Clinical Laboratory Assessments ........................................................................................80
7.11.1.
Correlatives/Special Studies..............................................................................81

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7.11.1.1
Sample Collection Guidelines...........................................................................81
7.11.1.2
Sample Processing, Storage, and Shipment ......................................................81
7.11.1.3
Assay Methodology...........................................................................................82
7.12 Study Treatment Application ..............................................................................................82
7.13 Post-Injection Evaluation and Injection Site Reaction Assessment....................................83
7.14 Pain Numeric Rating Scale..................................................................................................83
7.15 Tumor Imaging and Response Evaluation ..........................................................................83
7.15.1.
Definition of Lesions.........................................................................................84
7.15.2.
Method of Assessment ......................................................................................85
7.15.3.
Baseline documentation of ‘target’ and ‘non-target’ lesions ............................86
7.15.4.
Evaluation of target lesions...............................................................................87
7.15.5.
Evaluation of non-target lesions........................................................................88
7.15.6.
Evaluation of Best Overall Response................................................................88
7.15.7.
Duration of Response........................................................................................89
7.16 Survival Status.....................................................................................................................90
7.17 Standard of Care..................................................................................................................90
8
STATISTICAL ANALYSIS .................................................................................................91
8.1
Treatment Groups................................................................................................................91
8.2
Sample Size Determination and Rationale..........................................................................91
8.3
Randomization and Stratification........................................................................................91
8.4
Blinding...............................................................................................................................91
8.5
Interim Analysis ..................................................................................................................91
8.6
Statistical Considerations ....................................................................................................91
8.6.1.
Analysis Populations.........................................................................................91
8.6.1.1
Evaluable Population.........................................................................................91
8.6.1.2
Per Protocol Population.....................................................................................92
8.6.1.3
Safety Population ..............................................................................................92
8.6.2.
Covariates..........................................................................................................92
8.6.3.
Missing Data......................................................................................................92
8.7
Analysis Methods................................................................................................................92
8.7.1.
Subject Disposition............................................................................................92

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8.7.2.
Demographic and Baseline Disease Characteristics .........................................92
8.7.3.
Study Analyses..................................................................................................92
8.7.3.1
Safety Analyses .................................................................................................94
9
ADVERSE EVENTS (DEFINITIONS AND REPORTING) ............................................96
9.1
Adverse event (AE).............................................................................................................96
9.2
Reporting and Follow-Up of Adverse Events .....................................................................96
9.2.1.
Impact on Study Treatment...............................................................................96
9.2.2.
CTCAE Grade (Intensity) Assessment..............................................................96
9.2.3.
Causality Assessment........................................................................................97
9.2.4.
Treatment Given as a Result of the Event.........................................................98
9.2.5.
Outcome Assessment ........................................................................................98
9.2.6.
Injection-site reactions ......................................................................................98
9.3
Serious Adverse Events.......................................................................................................98
9.4
Reporting of Serious Adverse Events .................................................................................99
9.5
SAE Follow-Up...................................................................................................................99
10 DIRECT ACCESS TO SOURCE DATA/DOCUMENTATION ....................................100
11 QUALITY CONTROL AND QUALITY ASSURANCE.................................................101
11.1 Monitoring Requirements..................................................................................................101
11.2 Acceptability of Case Report Forms (CRFs) ....................................................................101
11.3 Modification of Protocol ...................................................................................................102
11.4 Reporting Protocol Deviations ..........................................................................................102
11.4.1.
Major Protocol Deviation or Violation ...........................................................102
11.4.2.
Minor Protocol Deviation or Violation ...........................................................103
12 DATA SAFETY MONITORING BOARD (DSMB) ........................................................104
13 ETHICS AND REGULATORY REQUIREMENTS .......................................................106
13.1 Institutional Review Board/Independent Ethics Committee (IRB/IEC) ...........................106
13.2 Investigator’s Responsibilities ..........................................................................................106
13.3 Subject Informed Consent Requirements..........................................................................107
14 DATA HANDLING AND RECORD KEEPING..............................................................108
14.1 Recording and Collection of Data.....................................................................................108

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14.2 Clinical Data Management................................................................................................108
14.3 Archiving...........................................................................................................................109
15 PUBLICATION PLAN .......................................................................................................111
16 REFERENCES.....................................................................................................................112
17 APPENDIX...........................................................................................................................116
17.1 Appendix 1:  Acceptable methods of Contraception.........................................................116
17.2 Appendix 2: Common Terminology Criteria for Adverse Events v5.0 ............................117

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LIST OF TABLES
Table 1-1:
List of Completed Clinical Studies with leronlimab (PRO 140).............................44
Table 1-2:
List of Ongoing Clinical Studies with leronlimab (PRO 140)................................46
Table 4-1:
Schedule of Assessments.........................................................................................57
Table 6-1:
Treatment Administration Summary.......................................................................70
Table 6-3:
Leronlimab (PRO 140) Dose Modification and Management for Injection Site 
Reactions .................................................................................................................73
Table 7-1:
ECOG Performance Status Scale ............................................................................79
Table 7-2:
Central Lab Parameters ...........................................................................................80
Table 7-3:
Target Lesion Evaluation ........................................................................................87
Table 7-4:
Non-Target Lesion Evaluation................................................................................88
Table 7-5:
Time point response: subjects with target (± non-target) disease ...........................89
Table 9-1: 
CTCAE v5.0 General Guidelines............................................................................97

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LIST OF FIGURES
Figure 1-1:
CCR5 over-expression correlates with poor survival). Immunohistochemical 
staining for CCR5 in 537 patients ...........................................................................24
Figure 1-2:
The CCR5 antagonist Maraviroc inhibits lung metastases in vivo .........................25
Figure 1-3:
Tumor Tregs (Stain with CD4, CD325, CD127, and CCR5)..................................27
Figure 1-4:
IHC staining showing high predominance of CCR5+ tumor infiltrating leukocytes 
in TNBC (Subject 1)................................................................................................28
Figure 1-5:
IHC staining showing high predominance of CCR5+ tumor infiltrating leukocytes 
in TNBC (Subject 2)................................................................................................29
Figure 1-6:
PRO-140 binds human CCR5 in human breast cancer cells..................................31
Figure 1-7:
PRO140 blocks human CCR5 mediated signaling in human breast cancer cells. .33
Figure 1-8:
PRO140 blocks CCL5-induced breast cancer cell invasion...................................34
Figure 1-9:
Part 1: SW480 Human Colon Carcinoma Xenografts Grown in NCr Nude Mice.35
Figure 1-10:
Part 2: SW480 Human Colon Carcinoma Xenografts Grown in NCr Nude Mice.36
Figure 1-11:
Part 3: SW480 Human Colon Carcinoma Xenografts Grown in NCr Nude Mice.36
Figure 1-12:
Part 4: SW480 Human Colon Carcinoma Xenografts Grown in NSG Mice .........37
Figure 3-1:
Study Schematic......................................................................................................51
Figure 4-1:
Study Flow Diagram ...............................................................................................56
Figure 6-1:
Investigational Product - Vial Label .......................................................................71
Figure 6-2:
Investigational Product - Syringe Label..................................................................71
Figure 6-3:
Investigational Product - Kit Label .........................................................................72
Figure 7-1:
Numeric Rating Scale..............................................................................................83

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LIST OF ABBREVIATIONS
Abbreviation
Term
AE
Adverse Event
ALP
Alkaline Phosphatase
ALT
Alanine Aminotransferase
AST
Aspartate Aminotransferase
BUN
Blood Urea Nitrogen
CAML
Cancer-Associated Macrophage-Like cell
Cmax
Maximal Concentration
cART
Combination Antiretroviral Therapy
CBR
Clinical Benefit Rate
CCL5
C-C Chemokine Ligand Type-5
CCR5
C-C Chemokine Receptor Type-5
CFR
Code of Federal Regulations
CHO
Chinese Hamster Ovary
CNS
Central Nervous System
CRF
Case Report Form
CRO
Contract Research Organization
CS
Clinically Significant
CTC
Circulating Tumor Cells
CTCAE
Common Terminology Criteria for Adverse Events
DAPI
4,2-diamidino-2- phenylindole dihydrochloride 
DSMB
Data Safety Monitoring Board
ECG
Electrocardiogram
ECL2
ExtraCellular Loop 2
ECOG
Eastern Cooperative Oncology Group
eCRF
Electronic Case Report Form
EOT
End of Treatment
FDA
U.S. Food and Drug Administration
FI
Fluorescent Intensity 
FOCBP
Females of Child-bearing Potential
GCP
Good Clinical Practice
GMP
Good Manufacturing Practice

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Abbreviation
Term
HDR
Homology-Directed DNA Repair
HEENT
Head, Ears, Eyes, Nose, and Throat
HIPAA
Health Insurance Portability Accountability Act
HIV-1
Human Immunodeficiency Virus Type 1
IA
Interim Analysis
ICF
Informed Consent Form
ICH
International Conference on Harmonization
IEC
Independent Ethics Committee
IHC
Immunohistochemistry assay
IND
Investigational New Drug
IP
Investigational Product
IRB
Institutional Review Board
ISR
Injection Site Reactions
ITT
Intent-to-Treat
IV
Intravenous
LAR
Legally Authorized Representative
LTF
Lost to Follow-up
mAb
Monoclonal Antibody
MSS
Microsatellite Stable
MTD
Maximum Tolerate Dose
Nt
N terminus
OBT
Optimized Background Therapy
ORR
Overall Response Rate
OS
Overall Survival
OTC
Over the Counter
PFS
Progression Free Survival
PI
Principal Investigator
PK
Pharmacokinetics
PP
Per Protocol
RECIST
Response Evaluation Criteria in Solid Tumors
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan

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Abbreviation
Term
SC
Subcutaneous
SD
Stable Disease
SLD
Sum of the Longest Diameters
SOP
Standard Operating Procedure
SV
Screening Visit
TEAE
Treatment Emergent Adverse Event
TTNM
Time to New Metastasis
VAS
Visual Analog Scale
VF
Virologic Failure

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1
INTRODUCTION AND BACKGROUND
1.1
STATEMENT OF INTENT
The design, conduct and reporting of this study shall be conducted in compliance with the 
protocol, International Conference on Harmonization/Good Clinical Practice (ICH/GCP), and all 
appropriate regulatory requirements. Investigator(s) participating in this study will have 
documented training in GCP. Independent monitoring of the trial will be accomplished utilizing a 
Contract Research Organization (CRO).
1.2
BACKGROUND OF THE DISEASE
Treatment for solid tumors generally combines several types of therapy, which may include 
surgery, chemotherapy and radiation therapy. Resistance of human tumors to anticancer drugs is 
most often ascribed to gene mutation, gene amplification, or epigenetic changes that influence the 
uptake, metabolism, or export of drugs from single cells. Another important cause of anticancer 
drug resistance is the limited ability of drugs to penetrate tumor tissue and to reach all of the 
tumor (Trédan, 2007). 
There are a large number of cancer drugs approved by the FDA for the treatment of solid tumors 
based on their genetic and molecular features and not on where the tumors originated in the body. 
This treatment approach is often called tissue-agnostic therapy or tumor-agnostic therapy. 
Entrectinib (NTRK gene fusion), Keytruda (Pembrolizumab) (PD-L1 Protein), Larotrectinib 
Sulfate (NTRK gen fusion), Pembrolizumab (PD-L1 protein), Rozlytrek (Entrectinib) (NTRK gen 
fusion), Vitrakvi (Larotrectinib Sulfate) (NTRK gene fusion) are drugs approved to treat solid 
tumors based on tumor genetic rather than cancer type.
1.2.1. C-C Chemokine Receptor Type-5 (CCR5)
The process of cancer cell metastasis in different organs is a complex biologic event. Each tumor 
type presents a unique pattern of dissemination that has been well recognized for over a century 
as the “soil and seed” hypothesis [Paget, 1889]. However, only recently factors involved in this 
process have started to be understood. Preclinical and clinical data have suggested that chemokine 
receptors and its ligands, also referred as chemoattractant or chemotactic cytokines, are involved 
in the process of cancer cells tropism by specific organs [Moser, 2001][Neagu, 2015][Velasco-
Velazquez, 2012][Chow, 2014]. Studies have correlated the altered expression of C-C Chemokine 
Ligand type-5 (CCL5) with disease progression in patients with breast cancer [Luboshits, 
1999][Niwa, 2001][Zhang, 2009]. Immunofluorescence staining techniques are well established 
for CCR5 expression. Velasco-Velazquez et al have evaluated an analysis of a combined 
microarray database comprising 2,254 breast cancer samples and showed that expression of 

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CCL5/CCR5 is higher in basal subtypes (over 58% of samples) of breast cancer compared to 
luminal subtypes [Velasco-Velazquez, 2012].
Figure 1-1:
CCR5 over-expression correlates with poor survival). Immunohistochemical 
staining for CCR5 in 537 patients
CCR5 is also associated with programmed death-ligand 1 (PD-L1) [Halama, 2016]. Anti-PD-L1 
antibodies have shown outstanding efficacy in the clinic for melanoma, non-small cell lung 
cancer and other cancers [Moser, 2001] [Garon, 2015] [Borghaei, 2015][Brahmer, 2015][Larkin, 
2015]. Upregulation of PD-L1 may allow cancers to evade the host immune system and also 
inducing apoptosis in activated T cells. Preclinical data have shown that PD-L1 present in cancer 
is correlated with CCR5 abundance. Thus, blocking CCR5 may also contribute to increased 
immune response against tumor cells. 
CCR5 has been shown to be sufficient to induce in vitro invasiveness and metastasis of breast 
cancer cells that is blocked by CCR5 inhibitors. Two distinct CCR5 inhibitors (Maraviroc, 
Vicriviroc) blocked CCR5 signaling and thereby blocked cells migration, invasion and metastasis
in mice (Figure 1-2) [Velasco-Velazquez]. The CCR5 inhibitors were shown to block homing of 
breast cancer cells to the lungs. The dose of CCR5 inhibitor used in these mouse models was the 
same as the dose used in patients for HIV treatment. Preclinical studies have also demonstrated 
that oncogenic transformation of immortal human breast cancer cells, with either Ha-Ras, c-Myc, 
ErbB2 (NeuT) or c-Src, induces the mRNA expression and protein abundance of CCR5 during
the process of transformation [Velasco-Velazquez].

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Figure 1-2:
The CCR5 antagonist Maraviroc inhibits lung metastases in vivo
Another cancer hallmark that CCR5 presents potential role is the DNA repair pathways. This 
cancer characteristic attenuates apoptosis and contributes to chemotherapy resistance and tumor 
cells immortality. Preclinical data have separated CCR5+ vs CCR5- SUM159 cells by FACS and 
conducted mRNA gene expression profiling. GO term pathway analysis demonstrated CCR5+ 
cells induced the expression of pathways governing DNA repair. QT- PCR was used to quantitate 
a number of these genes and showed endogenous CCR5 enhances expression of the DNA repair 
genes, (FANCB, LIG3, POLE and CRY1) governing both homologous and non-homologous 
DNA repair, nucleotide excision repair and base excision repair. SUM159 cells stably transfected
with CCR5 or control vector were
-radiation of 
SUM159 cells induced p-
AX, however CCR5-overexpressing cells showed reduced p-
-overexpressing cells showed less p-
24 hours treatment. The DNA repair reporter, DR-GFP is used to
measure homology-directed DNA repair (HDR). In order to measure HDR activity CCR5+ 
SUM159 cells, the cells were co-transfected with the plasmid encoding I-SceI and the I-SceI 
based DNA repair reporter DR-GFP and stained with APC labeled anti-CCR5 antibody. GFP+
cells, generated by HDR of I-SceI induced double-strand DNA, were sorted by FACS into CCR5-
and CCR5+ populations. The percentage of DR-GFP+ cells was increased in CCR5+ or CCR5-

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overexpressing cells compared with CCR5- or vector control cells [Robert, 2015]. The dramatic 
enhancement of DNA repair signaling by CCR5 activation may contribute to the resistance of a 
patient’s tumor to chemotherapeutic agents.
1.2.2. Circulating Tumor Cells (CTCs)
The major treatment objectives in the advanced stage disease remain palliation of symptoms and
improvement of quality of life. Importantly, cancer is a heterogeneous disease and long-term
patient outcome can be influenced by various biological features, as well as by the extent and site 
of metastatic disease. Typically, widespread visceral disease is associated with symptomatic 
progression leading to deterioration of the performance status and short survival. Various 
molecular markers and blood-based tests have been investigated as surrogate for more aggressive 
disease, among them the most reliable appears enumeration of circulating tumor cells [Xuanmao, 
2015].
During the last decade, several techniques capable of detecting and quantifying circulating tumor
cells (CTCs) in cancer patients have been developed. It has been proposed that subpopulation of 
CTCs with tumor initiating potential act as a central mediator of metastatic dissemination, giving
rise to the formation of distant micrometastases, which subsequently generate overt detectable and 
frequently measurable lesions [Foulkes, 2010]. In support of this theory, multiple studies have 
shown that a number of CTCs higher or equal than 5 per 7.5 mL of blood, evaluated before 
starting systemic treatment, is associated with poor outcome in patients with metastatic cancer
[Xuanmao, 2015]. In addition, high CTC counts are associated with greater metastatic tumor burden, 
expressed as number of metastatic sites [Moser,2001][Neagu, 2015]. Importantly, despite this
association, the prognostic value of CTCs is independent from the initial number of metastatic 
sites [Moser,2001][Neagu, 2015]. Moreover, a recent pooled analysis of 1944 patients was
performed confirming those data [Cristofanilli, 2004]. The authors created a clinicopathological 
prognostic model to determine the added impact of CTCs for PFS and OS. They found that 
for OS and PFS. The prognostic value of CTCs was consistent across all subtypes of disease. 
Finally, in the multivariate analysis, CTC count was the strongest prognosticator for PFS and OS. 
Furthermore, continued elevation of CTCs is known to be associated with a poor prognosis as 
well as a sign of chemoresistance [Bidard, 2014].
CTCs enumeration will be used as a measure of tumor cells escaping immune control and 
released into the blood. CTCs enumeration is used as a surrogate of metastasis and as a measure 
of the efficacy of therapy. CCR5 has also been implicated in the migration of tumor cell from 
blood into tissues so if CTCs are reduced by therapy but still present, a favorable result would be 
that they are no longer CCR5 positive due to receptor blockade by leronlimab. 

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1.2.3. CCR5+ Tumor-Infiltrating Leukocytes
The role of CCR5 blockade of the CCL5-CCR5 pathway in immune control of tumors have been 
defined in several publications in the peer-reviewed medical literature [Mañes, 2003]. CCR5 on 
tumor cells especially those that evade local immune control in the primary tumor leads to CCR5 
positive circulating tumor cells that have the capability to disseminate and migrate into distant 
tumor sites again through the CCL5-CCR5 axis. Previous research and current data has also 
identified other immune mediated anti-tumor effects from CCR5 blockade [Lanitis, 2017, 
Halama, 2016]. Previous published reports suggest CCR5 expression on Treg cells which migrate 
into tumors due to the expression of CCL5 by lymphocytes [de Oliveira, 2017, Del Prete, 2017, 
Lanitis, 2017]. Tregs are responsible for minimizing or eliminating the anti-tumor effects of CD8 
T-cells now restored by blockade of PD-L1/PD-1 by the new class of immune-oncology drugs [de 
Oliveira, 2017]. Further, blocking CCR5 on tissue associated macrophages (TAMS), one of the 
major cells in the tumor microenvironment that suppresses the T-cell mediated anti-tumor 
immune response, restores the anti-tumor activity by re-programming the TAMs [Lanitis, 2017, 
Walens, 2019]. Data from novel 24-color flow cytometry assay performed on single cell 
suspensions created with IVD IncellPREP device, confirmed the expression of CCR5 on Tregs 
from the tumor microenvironment in lung, breast, and bladder cancer samples. This technology or 
CCR5 immunohistochemistry of biopsies already obtained has allowed to selectively choose 
patients with CCR5 expression not only on tumor but on intra-tumor immune cells in the tumor 
microenvironment.
Figure 1-3:
Tumor Tregs (Stain with CD4, CD325, CD127, and CCR5) 

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Because of the multitude of different mechanism CCR5 blockade may promote anti-tumor 
activity, immune control, and metastasis, the inclusion criteria has been expanded to encompass 
these varied mechanisms that may all lead to improved clinical response. 
Below are representative IHC staining images showing high predominance of CCR5 positive 
tumor infiltrating leukocytes in Triple Negative Breast Cancer tissue samples:
Figure 1-4:
IHC staining showing high predominance of CCR5+ tumor infiltrating 
leukocytes in TNBC (Subject 1)
(A)Subject 1: Representative images of IHC for CCR5
(B) Negative Control CCR5
(C)Positive Control CCR5

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Figure 1-5:
IHC staining showing high predominance of CCR5+ tumor infiltrating 
leukocytes in TNBC (Subject 2)
(A)Subject 2: Representative images of IHC for CCR5
(B) Negative Control CCR5
(C)Positive Control CCR5
1.3
STUDY TREATMENTS
1.3.1. Leronlimab (PRO 140)
Leronlimab (PRO) 140 is a humanized IgG4,
monoclonal antibody (mAb) to the C-C chemokine 
receptor type 5 (CCR5), under development as a therapy for human immunodeficiency virus 
(HIV) infection.
Leronlimab (PRO 140) binds to the N terminus (Nt) and the extracellular loop 2 (ECL2) domain 
of the CCR5 cell surface receptor that HIV-1 uses to gain entry to a cell. Leronlimab (PRO 140) 
(binding to CCR5 blocks viral entry by interfering with the final phase of viral binding to the cell 

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surface prior to fusion of the viral and cell membranes. Leronlimab (PRO 140) has been 
administered intravenously or subcutaneously to more than 750 healthy and HIV-1 infected 
individuals in Phase I/II/III studies. The drug has been well tolerated following intravenous 
administration of single doses of 0.5 to 10 mg/kg or up to 700 mg weekly doses as subcutaneous 
(SC) injection. Overall, 324 subjects have been exposed to leronlimab (PRO 140) 350 mg SC 
weekly dose with the longest duration of exposure lasting 4 years. Similarly, more than 250 and 150 
subjects have been exposed to leronlimab (PRO 140) 525 mg and 700 mg SC weekly dose, 
respectively.
1.4
PRE-CLINICAL STUDIES OF LERONLIMAB (PRO 140)
In vitro and in vivo preclinical studies have been conducted to determine the pharmacokinetic, 
immunogenicity, and toxicity profiles of leronlimab (PRO 140) following IV and SC 
administration. Several acute and chronic toxicity studies have been conducted to support the 
clinical development plan. 
Acute toxicity of leronlimab (PRO 140) was evaluated in New Zealand rabbits, following IV 
administration of 5 or 15 mg/kg. Chronic toxicity was evaluated in cynomolgus monkeys 
following biweekly administration of IV doses up to 10 mg/kg for six months and biweekly 
administration of various SC doses up to 50 mg/kg for 24 weeks. The drug was generally well 
tolerated. Biweekly administration of IV doses up to 10 mg/kg for six months resulted in 
minimum to mild lymphoid hyperplasia in assorted lymph nodes and spleen, which was 
considered an expected immune response to a foreign protein. Biweekly administration of SC 
doses up to 50 mg/kg for 24 weeks resulted in minimum injection-site reactions (minimal, 
multifocal, mononuclear cell infiltrates in the subcutis), which were considered due to an 
inflammatory response to the injected antigen. Monkeys tolerated treatment with leronlimab 
(PRO 140) for 24 weeks without evidence of local or systemic toxicity. Leronlimab (PRO 140) 
caused no mortality, cageside observations, in-life injection-site observations, or gross 
pathologic findings. Chronic treatment with leronlimab (PRO 140) did not affect body weight, 
food consumption, hematology, clinical chemistry or coagulation parameters.
Both IV and SC administration resulted in elimination half-lives of approximately 200 hours, 
and overall exposure increased with increasing doses. Following SC administration of 
leronlimab (PRO 140) in monkeys, the maximal concentration (Cmax) was achieved within 56 
hours and bioavailability for leronlimab (PRO 140) after SC dosing was approximately 70%.

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1.4.1. Effect of PRO140 on human CCR5 in breast cancer cells, MDA-MB-231
1.4.1.1
PRO140 binding to human CCR5 in human breast cancer cells
Figure 1-6:
PRO-140 binds human CCR5 in human breast cancer cells.
Validation of PRO140 binding to CCR5 positive cells was assessed by FACS analysis. MDA-MB-231 stably 
expressing a human CCR5 expression vector was double stained with a commercial APC-conjugated mouse anti-
human/mouse/rat CCR5 antibody and PRO140. Alexa Fluor 488 conjugated anti-human IgG was used as secondary 
antibody of PRO140. PRO 140 was diluted from 1/50 to 1/3200. (B) The efficiency of PRO140 binding to the CCR5 
positive cells.
In order to determine the binding of PRO140 with human CCR5 in breast cancer cells, MDA-
MB-231, a human triple-negative breast cancer cell line, was stably transfected with a human 
CCR5 expression vector as a model system. A commercial APC conjugated mouse anti-
human/mouse/rat CCR5 antibody was used as a positive control to assess CCR5 positive cells. 
MDA-MB-231-CCR5 cells were stained with both APC-
from 1/50 to 1/3200 (Figure 1). Alexa Fluor 488 conjugated mouse anti-human IgG was used as
secondary antibody to measure PRO140 binding cells. Analysis of PRO140 binding with CCR5 

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by FACS is shown in Figure 1-6. The efficiency of PRO140 binding with CCR5 was calculated as 
the ratio of Alexa Fluro 488 positive cells to APC positive cells. The efficiency of PRO140 
binding to CCR5 positive cells was 62% at 1/800 dilution (Figure 1-6A, B). These results 
demonstrate that PRO140 binds with human CCR5. 
1.4.1.2
PRO140 blocks human CCR5 mediated signaling in human breast cancer cells. 
CCR5 activation induces calcium flux [Mueller, 2002][Petkovic, 2004]. To assess the effects of 
PRO140 on CCR5 function, we measured the calcium responses induced by CCL5 in MDA-MB-
231-CCR5 cells with or without PRO140 by living cell image (Figure 1-7). Fluo-4 was used as 
calcium concentration indicator. The CCR5 antagonist, Vicriviroc, was used as a positive control 
(Figure 1-7). 
MDA-MB-231-CCR5 cells were labeled with calcium indicator Fluo-4 and monitored under 
fluorescent inverted microscope with the incubator chamber at 37ºC and 5% CO2. For treated 
samples, a CCR5 inhibitor, either PRO140 or Vicriviroc, was added 30 minutes prior to the 
experiments. Video of living cells was taken at 20 sec intervals. CCL5 was added after 6 frames 
of the video, and FBS induced calcium responses were used as positive control. A representative 
example is shown in Figure 1-7. Relative intracellular Ca2+ concentration was determined by the 
changes in fluorescent intensity (FI) of Fluo-4-
Quantitative analysis of calcium responses induced by CCL5 are represented in Figure 1-7 (B) 
control, (C) PRO140, and (D) Vicriviroc. Data is shown as mean ±SEM from 10-12 cells.
The results showed that PRO140 can block CCL5 induced calcium responses in MDA-MB-231-
CCR5 cells at 1/100 dilution. (1.23±0.10, N=10 for control cells and 0.54±0.13 N=12 for PRO140 
treated cells. P<0.001 at calcium peak induced by CCL5).
1.4.1.3
PRO140 blocks human CCR5 mediated invasion of extracellular matrix in human 
breast cancer cells. 
Our previous studies using CCR5 specific small molecule inhibitors demonstrated that CCR5 is 
required for the invasion of extra-cellular matrix in both breast and prostate tumor models [Sicolo, 
2014][Velasco-Velazquez, 2012]. Cancer cell invasion into the extra-cellular matrix is a key step 
of tumor metastasis [Zetter, 1990]). 
MDA-MB-231 cells were used to test the ability of PRO140 to block cell invasion in a 3D-
matrigel assay. CCL5 was used as chemoattractant to induce the invasion. Vicriviroc, a small 
molecule inhibitor of CCR5, was used as a form of positive control. 
The results showed that PRO140 can block CCL5 induced MDA-MB-231 breast cancer cell 
invasion with similar efficacy as Vicriviroc (Figure 1-8A, B) (855±9, N=8 for control vs 855±9, 
N=9 for PRO140, P <0.001). We also tested the effects of different doses of PRO140 on breast 
cancer cell invasion, and the results showed that both a 1/500 and a 1/1000 dilution of PRO140 

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can effectively block MDA-MB-231 cell invasion (Figure 1-8C, D). Data is shown as mean ± 
SEM of the distance of cell invasion.
Figure 1-7:
PRO140 blocks human CCR5 mediated signaling in human breast cancer 
cells. 
The effects of PRO140 on CCL5 induced Ca+2 responses. MDA-MB-231 stable expressing CCR5 cells was labeled 
with Calcium indicator Fluo-4 and monitored under fluorescent inverted microscope with incubator chamber at 37oC 
and 5% CO2. Video of living cells was taken with 20 sec intervals. 30 minutes prior to the experiments, PRO140 or 
Vicriviroc was added. CCL5 was added after 6 frames of the video and FBS induced calcium responses were used as 
a positive control. A representative example is shown. (B-D) quantitative analysis of calcium responses induced by 
CCL5 in control (B), PRO140 (C) or Vicriviroc (D) treated cells. Data is shown as mean ±SEM from 10-12 cells.

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Figure 1-8:
PRO140 blocks CCL5-induced breast cancer cell invasion 
3D reconstruction of CCL5-induced invasion into collagen I gels by MDA-MB-231 breast cancer cells in presence of 
PRO140. CCL5 was used as chemoattractant. (A, B) The comparison of the effects of PRO14 and Vicriviroc. (C, D) 
The effects of different doses of PRO140 is shown. Data is shown as mean ± SEM of the distance of cell invasion.
1.4.2. Effect of PRO 140 on Growth of SW480 Human Colon Carcinoma Xenografts
A study was conducted to determine the anti-tumor activity of PRO 140 humanized monoclonal 
antibody against CCR5 in mouse xenograft models of SW480 human colon carcinoma grown in 
immunocompromised mice. The study was conducted in four parts, using different mouse strains, 
drug doses, and drug schedules. 
SW480 human colon carcinoma cells (ATCC) were expanded in culture (DMEM, 10%FBS, 
antibiotic, antimycotic) and were inoculated subcutaneously (2 million per site, s.c.) in the flanks 
of male NCr nu/nu mice (Taconic), and male NOD-scid-IL2Rg (NSG) mice (Jackson). Mice were 
randomized to receive Control human IgG or PRO 140 intraperitoneal injection (i.p.) twice per 
week (Mon, Thu). Tumor diameters were measured 3 times weekly (Mon, Wed, Fri) with 

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calipers, and tumor volume calculated using the formula for a prolate spheroid. The body weight 
of mice was determined weekly (Wed). 
In Part 1 (high dose, early Rx) of the study, 2 mg PRO 140 i.p. was administered twice weekly, 
starting at Day 1 in 16 athymic nude mice. Part 2 (high dose, late Rx) included 8 athymic nude 
mice receiving 2 mg PRO140 i.p administered twice weekly, beginning Day 21.
In Part 3 (low dose, early Rx), 0.2 mg PRO 140 i.p was administered, beginning on Day 1, twice 
weekly in 16 athymic nude mice. Lastly, in Part 4 (high dose, early Rx), 16 NSG mice received 2 
mg PRO 140 i.p, twice weekly, beginning Day 1.
PRO 140 dosage was calculated using “Representative Surface Area to Weight Ratios (km) for 
Various Species” from: Freireich EJ, Gehan EA, Rall DP, Schmidt LH, Skipper HE. Quantitative 
comparison of toxicity of anticancer agents in mouse, rat, hamster, dog, monkey, and man, 
Cancer Chemother Rep. 1966;50:219-44; and the National Cancer Institute Developmental 
Therapeutics Program http://dtp.nci.nih.gov
Starting with the human dose of PRO 140 = 5.8 mg/kg x 12 (man-to-mouse conversion factor) = 
69.6 mg/kg mouse dose. Average mouse = 0.025 kg, therefore 69.6 mg/kg x 0.025 kg = 1.74 mg 
(mouse single dose). This was rounded up to 2.0 mg and designated as the high dose. A low dose 
(0.2 mg) was also tested. As control antibody, IgG derived from human serum was used (>95% 
SDS-PAGE, Sigma, I4506).
In Part 1, administration of PRO 140 (2 mg i.p. twice a week) induced a 62.8% reduction in 
SW480 tumor volume by day 42 (p=0.014). Mice receiving PRO 140 exhibited normal weight 
gain over the course of the study, whereas mice receiving non-specific IgG lost weight during the 
second half of the study (p=0.047).
Figure 1-9:
Part 1: SW480 Human Colon Carcinoma Xenografts Grown in NCr Nude 
Mice
PRO 140 2 mg i.p. Twice/Wk, Started Day 1, n=16 Tumors/Group

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During Part 2, treatment of larger established tumors (volume: Cont 68.5 ± 47.25, PRO 140 47.25 
± 34.89 mm3) with PRO 140 (2 mg i.p. twice a week) commencing on day 21, did not result in 
significant inhibition of tumor growth (p=0.719).
Figure 1-10:
Part 2: SW480 Human Colon Carcinoma Xenografts Grown in NCr Nude 
Mice
PRO 140 (2 mg i.p. Twice/Wk), Started Late (D21), n= 8 Tumors/Group
In Part 3 of the study, administration of PRO 140 at a reduced dose (0.2 mg i.p. twice a week) 
induced an 18.3% reduction in SW480 tumor volume by day 42, but did not reach statistical 
significance (p=0.272). During tumor progression in the second half of the study, both groups 
exhibited similar degree of weight loss (p=0.708).
Figure 1-11:
Part 3: SW480 Human Colon Carcinoma Xenografts Grown in NCr Nude 
Mice
PRO 140 0.2 mg i.p. Twice/Wk, Started Day 1, n=16 Tumors/Group

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For Part 4, switching from nude mice (lack T cells) to a more immunosuppressed host (NSG lack 
T, B, NK cells) resulted in loss of PRO 140 anti-tumor efficacy. There was a 32% reduction in 
tumor volume in the PRO 140 groups compared to control, but this did not reach statistical 
significance (p=0.076). There was a similar degree of weight loss in both treatment groups 
(p=0.61).
Figure 1-12:
Part 4: SW480 Human Colon Carcinoma Xenografts Grown in NSG Mice 
PRO 140, 2 mg i.p. Twice/Wk Started Day 1, n=16Tumors/Group
1.4.3. Clinical Studies with leronlimab (PRO 140)
Current human experience with leronlimab (PRO 140) consists of nine completed and six 
ongoing clinical trials, mostly on healthy subjects or HIV-1 positive subjects. These studies are 
summarized in Table 1-1 and Table 1-2. In all clinical trials, the majority of adverse events 
(AEs) have been mild or moderate. No dose-limiting toxicities or patterns of drug-related 
toxicities were observed. Antiviral activity was potent, rapid, prolonged, dose-dependent, and 
highly significant.
1.4.4. PRO 140 1101 Study
For the first-in-human trial, PRO 140 1101, the drug was administered IV at 0.1, 0.5, 2.0, or 5.0 
mg/kg to healthy subjects and was generally well tolerated, non-immunogenic, and without 
clinically relevant toxicity. Treatment Emergent Adverse Events (TEAEs) did not increase with 
rising PRO 140 dose levels. Seventy-five percent (75%) of subjects reported TEAEs, most of 
which were deemed unrelated to study treatment by the investigator.
1.4.5. PRO 140 1102 Study
For PRO 140 1102, the majority of AEs, other than injection-site reactions, were considered mild 
and possibly related to drug administration. The majority of injection-site reactions were 
considered mild, self-resolving, and definitely related to drug administration. PRO 140 derived 

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from Chinese Hamster Ovary (CHO) cells and administered at 100 mg/mL was generally well 
tolerated in healthy, normal volunteers. Overall, PRO 140 administered SC using Autoject® 2 
appeared better tolerated than manual injection.
1.4.6. PRO 140 1103 Study 
In PRO 140-1103, administration of PRO 140 at 350 mg using Autoject® 2 appeared well 
tolerated. Manual injections, on the other hand, were associated with a greater number of AEs. 
There did not appear, however, to be any substantial difference in subject perception of pain or 
discomfort related to site of drug administration. No anti-PRO 140 antibodies were detected in 
any subjects in this study. There was a tendency of higher exposure associated with SC 
administration of PRO 140 at 350 mg in the abdomen and the thigh. A higher number of AEs 
were associated with injections in the arm. Based on these observations, thigh and abdominal 
administration of PRO 140 were preferred over arm injection.
1.4.7. PRO 140 1302 Study
The initial proof-of-concept study was a randomized, double-blind, placebo-controlled study in 
subjects with early-stage, asymptomatic HIV infection, only R5 HIV-1 detectable, and no 
antiretroviral therapy for 12 weeks [Jacobson, 2008]. Subjects (n=39) were randomized to receive 
a single IV injection of placebo or PRO 140 at doses of 0.5, 2, or 5 mg/kg. Subjects were 
monitored for antiviral effects, safety, and PRO 140 pharmacokinetics (PK) for 58 days. 
PRO 140 demonstrated potent, rapid, prolonged, and dose-dependent antiviral activity. 
Intravenous PRO 140 was generally well tolerated. No drug-related serious events or dose-
limiting toxicity was observed [Jacobson, 2008]. The most common adverse events (headache, 
lymphadenopathy, diarrhea, and fatigue) were observed at similar frequencies across the placebo 
and PRO 140 dose groups. There was no significant effect on QTc intervals or other 
electrocardiographic parameters, and there were no remarkably laboratory findings.
1.4.8. PRO 140 2301 Study
PRO 140 2301 was a multi-center, randomized, double-blind, placebo-controlled, parallel group 
study in 30 male and female adult subjects infected with HIV-1 [Jacobson, 2010]. Subjects were 
randomized to one of three groups (N=10/group), each receiving one of three treatments: (i) a 
single IV dose of 5 mg/kg by 30-minute IV infusion; (ii) a single IV dose of 10 mg/kg by 30-
minute IV infusion; (iii) a single placebo dose by 30-minute IV infusion. The objective of the 
study was to assess and characterize the PK and PD of PRO 140 administered by IV infusion, 
assess efficacy at a new dosage level, and safety and tolerability of single doses of PRO 140.
All PRO 140-treated subjects had more than 10-fold reduction in viral loads [Jacobson, 2010].
Both the 5 mg/kg and 10 mg/kg doses have shown favorable tolerability and no dose-limiting 

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toxicity has been observed. High levels of receptor occupancy (>85% reduction in the number of 
cells detected) were observed for 29 days after treatment with both 5 and 10 mg/kg doses. 
1.4.9. PRO 140 2101 Study
A subcutaneous (SC) form of PRO 140 was tested in HIV-infected subjects. The trial was a 
randomized, double-blind, placebo-controlled study in subjects (n=44) with early-stage, 
asymptomatic HIV infection, only R5 HIV-1 detectable, and no antiretroviral therapy for 12 
weeks [Thompson, 2009]. Placebo (n=10) and three PRO 140 doses were examined: 162 mg 
weekly for three weeks (n=11), 324 mg weekly for three weeks (n=11), and 324 mg biweekly 
(every other week) for two doses (n=12). Subjects were followed for 44 days after the final dose. 
Potent, dose-dependent and highly statistically significant antiviral activity was observed. The 
trial established the first antiviral proof of concept for a long-acting, self-administrable drug for 
HIV-1 infection [Thompson, 2009].
Subcutaneous PRO 140 was generally well tolerated both locally and systemically. There was no 
obvious dose-related pattern of toxicity. The most common adverse events (diarrhea, headache, 
lymphadenopathy and hypertension) were mild to moderate and self-resolving. These events are 
common in HIV infection and were reported with similar frequencies in the placebo and PRO 140 
treatment groups. Administration-site reactions were mild, transient, and observed in a fraction of 
subjects. 
1.4.10. PRO 140_CD01 Study
PRO 140_CD01 study (open-label, 43 subjects, multi-center) evaluated the efficacy, safety, and 
tolerability of PRO 140 monotherapy (350 mg subcutaneous injection weekly for up to 12 weeks) 
for the maintenance of viral suppression following substitution of antiretroviral therapy in HIV-1
infected patients (with exclusive CCR5-tropic virus). Participants in this study were experienced 
HIV-infected individuals who were virologically suppressed on combination antiretroviral 
therapy. Consenting patients were shifted from combination antiretroviral regimen to PRO 140 
monotherapy for 12 weeks. 
Forty-three (43) subjects (M/F: 37/3) with median age of 54.5 years (26-72) and median CD4 T-
cell count of 604.5 cells/mm3 (365-1240) were enrolled in the CD01 study. Overall, twenty-two 
out of 40 (55%) enrolled subjects completed 12 weeks of PRO140 monotherapy without 
experiencing virologic failure. Virologic failure was defined as two consecutive HIV-1 RNA 
subjects, 3 subjects 
were found to have Dual/Mixed (D/M) tropism [1 at baseline and 2 at the time of virologic 
failure] and 37 subjects were found to have exclusive CCR5-tropic virus. A letter of amendment 
was filed to increase the planned number of subjects from 40 to 43 subjects to compensate for the 
3 Dual/Mixed subjects enrolled in the study.

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All virologic failure subjects who had available lab data in both studies achieved viral suppression 
to < 400 HIV-1 RNA copies/mL, as well as viral suppression to ‘Non Detectable’ or < 50 HIV-1
RNA copies/mL after re-initiation of ART. 
The by-subject analysis of PhenoSense® Entry Assay data for PRO140, maraviroc, and 
AMD3100 shows no significant changes in the post-treatment IC50 and IC90 values were noted 
when compared with baseline values in virologic failure and non-virologic failure groups of 
subjects. As the aggregate analysis shows for initial 40 subjects, the subjects who experienced 
virologic failure had higher IC90 value for PR0140 at baseline compared to subjects without 
virologic failure. The mean IC90 for subjects who experienced virologic failure was higher (10.84 
µg/mL) than the IC90 for subjects without virologic failure (6.70 µg/mL) in the CD01 study 
(p=0.0115). 
Anti-PRO140 antibodies were not identified in any post-treatment sample and data derived from 
the CD01 study further supports the favorable PRO140 PK profile data generated from both pre-
clinical as well as prior Phase 1/2 clinical trials.
Safety data were analyzed for all 43 enrolled subjects. One (1) of 43 subjects experienced an SAE 
that was deemed not related to the study drug by the Principal Investigator. Twenty-eight (28) of 
43 subjects (67%) experienced one or more adverse events (AEs) after receiving at least one dose 
of PRO140. The most commonly occurring AEs were infections and infestation conditions which 
were reported by 14 of 43 (32.5%) subjects. The majority of the reported AEs (62/87; 71.2%) 
were deemed either unlikely or not related to study treatment by the Investigator. Similarly, the 
majority of the reported AEs (70/87; 80.4%) were deemed mild in nature. 
1.4.11. PRO 140_CD01 Extension Study
PRO 140_CD01-Extension study (open-label, 28 subjects, multi-center) seeks to evaluate the 
efficacy, safety, and tolerability of PRO 140 monotherapy (350 mg subcutaneous injection 
weekly) for the continued maintenance of viral suppression following substitution of antiretroviral 
therapy in HIV patients (with exclusive CCR5-tropic virus). Participants in this study were HIV-
infected individuals who were virologically suppressed on combination antiretroviral therapy and 
completed the first 12 weeks of CD01 study without experiencing virologic failure. As with the 
CD01 study, virologic failure was defined as two consecutive HIV-
copies/mL separated by at least 3 days. Consenting patients may remain on PRO 140 
monotherapy until PRO 140 receives marketing approval or IND is withdrawn by Sponsor. 
A total of 17 subjects participated in the CD01-Extension study of which one subject was 
considered not eligible as subject experienced virologic failure prior to first extension treatment.
Sixteen (16) eligible subjects (M/F: 14/2) with median age of 54.9 years (26-68) and median CD4 
T-cell count of 593 cells/mm3 (365-1059) were enrolled in an extension study. One patient 

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discontinued at week 37 (with viral load of <40 copies/mL) due to relocation. Two subjects were 
withdrawn due to non-treatment related SAEs at week 140 and 149, respectively. One subject was 
withdrawn due to re-starting their ART at week 99. Two subjects withdrew consent at week 81 
and 139, respectively. Five (5) subjects experienced virologic failure (VF) (two consecutive viral 
-691). 
Five (5) subjects are currently receiving weekly 350 mg PRO140 SC monotherapy and have 
completed more than three years of treatment (176 - 198 weeks). Overall, 12 subjects completed 
at least one year of treatment and 9 subjects completed at least two years of treatment in this study
PRO140 was generally well tolerated, and no drug-related SAEs were observed.
This clinical study is currently ongoing.
1.4.12. PRO 140_CD02 Study
PRO 140_CD02 study (double blind, placebo controlled, 52 subjects, multi-center) seeks to 
evaluate the efficacy, safety, and tolerability of PRO 140 in combination with either existing ART 
(failing regimen) or Optimized Background Therapy (OBT) in patients infected with HIV-1. The 
study population includes 52 adult patients with a documented history of genotypic or phenotypic 
resistance to ART drugs within two or more drug classes who demonstrate evidence of HIV-1
replication despite ongoing antiretroviral therapy and have limited treatment options. The options 
may be limited as a result of drug antiviral class cross-resistance, documented treatment 
intolerance, documented objective assessments such as renal or hepatic insufficiency (e.g. high 
creatinine at baseline, limiting treatment options due to potential for toxicity), past adverse 
reactions such as hypersensitivity reactions or neuropsychiatric issues that could limit use of 
currently approved drugs.
In Part 1 of double-blind treatment period, virally non-suppressed subjects will be randomized 
and treated with either PRO 140 or Placebo in combination with the failing ART regimen for 7 
days until HIV-1 genotypic drug resistance assay results are available to construct an OBT. The 
-1 RNA 
viral load from baseline at the end of the 7 day functional monotherapy period.
In Part 2 of double-blind treatment period, subjects will continue treatment with PRO 140 in 
combination with OBT within the 24-week open-label period. 
Fifty-two subjects with a mean age of 52.4 years, 73.1% male, 48.1% non-white and mean 
duration of HIV-1 infection of 20.4 years were randomized 1:1 to the PRO 140 SC or placebo 
arm. Subjects had been previously exposed to an average of 11 ART drugs and had documented 
resistance to >9 ART drugs. Mean baseline VL and CD4 cell count were 21,104 c/mL and 297.8 
c/mm3, respectively. The primary efficacy endpoint- the propo

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reduction in HIV-1 VL from baseline at the end of the 1-week double-blind, randomized, 
placebo-controlled treatment period- was met (16/25 vs 6/26 [p-value <0.0032, ITT population]). 
Forty seven (47) of 52 patients have completed the 25-week study. Approximately 81% of 
patients completing 25-weeks of PRO 140 SC treatment demonstrated HIV-1 VL <50 c/mL and 
92% had HIV-1 VL <400 c/mL. Continued access to PRO 140 SC was provided through a 
rollover study and 40 patients entered the extension protocol after completing the CD02 study. 
PRO 140 SC was generally well tolerated. No drug-related SAEs or treatment discontinuations 
were reported in the study.
This clinical study is completed pending final database lock. 
1.4.13. PRO 140_CD02 Extension Study
PRO 140_CD02 Extension study (open label, 40 subjects, multi-center) seeks to evaluate the long 
term efficacy, safety and tolerability of PRO 140 weekly injection in combination with Optimized 
Background Therapy (OBT) in patients infected with HIV-1. The study population includes 40 
treatment-experienced HIV-infected adult patients with CCR5-tropic virus who successfully 
completed PRO 140_CD02 study and continue to demonstrate HIV-1 viral suppression.
This clinical study is currently ongoing.
1.4.14. PRO 140_CD03 HIV Study
PRO 140_CD03 HIV (open-label, 350 subjects, multi-center) is a three part study enrolling 
virally suppressed HIV-1 patients with CCR5-tropic HIV-1 receiving combination antiretroviral 
(cART) therapy. Patients received weekly doses of PRO 140 on single-agent maintenance therapy 
following one week of overlap of the existing cART regimen that is then discontinued. In part 1, 
156 participants received 350 mg PRO 140 SC in a single-arm design. In part 2, 147 participants 
received 350 or 525 mg PRO 140 SC in a 1:1 ratio as randomized controlled, two-arm study. In 
an ongoing part 3, 51 participants have been randomized to receive 525 or 700 mg PRO 140 SC 
in a 1:1 ratio. 
Despite reaching the enrollment target of 350 subjects for the PRO140_CD03 HIV study, the 
enrollment is ongoing as the goal of enrolling 20 subjects for the CNS sub-study have not 
achieved. As a result, sites that are currently participating in the CNS sub-study are permitted to 
continue enrollment in the CD03 HIV study.
Of the 354 patients enrolled, median age was 51 yrs (21-77) with the majority reported as male 
(79%) and 37% were non-white. A total of 27 subjects have been randomized to 700 mg dose. In 
addition, another 18 subjects have been exposed to 700 mg dose after rescuing from the lower 
doses (350 mg or 525mg). On average, participants were diagnosed with HIV-1 infection for 16.8 
yrs and were on cART regimen for 14.8 yrs. The frequency and severity of injection site reactions 

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were comparable between the three dose groups (350, 525 and 700mg) and the incidence or 
severity of injection site reactions was not increased in patients receiving higher doses. Overall, 
PRO 140 SC was generally well tolerated at all dose levels in this study.
This clinical study is currently ongoing.
1.4.15. PRO 140_CD03 HIV Extension Study
PRO 140_CD03 study (open-label, 350 subjects, multi-center) seeks to evaluate the long term 
efficacy, safety and tolerability of PRO 140 SC as long-acting single-agent maintenance therapy 
in virologically suppressed subjects with CCR5-tropic HIV-1 infection. The study population 
includes up to 300 treatment-experienced HIV-infected adult patients who successfully completed 
PRO 140_CD03 HIV study and continue to demonstrate HIV-1 viral suppression.
This clinical study is currently ongoing.
1.4.16. PRO 140_CD06 Study
PRO 140_CD06 study (double-blind, 80 subjects, single-center) seeks to evaluate the evaluate 
comparability of PRO 140 formulation Batch Lot # 3-FIN-3143 versus formulation Batch Lot# 3-
FIN-2618 as a one-time subcutaneous (SC) injection in healthy subjects under non-fasting 
conditions. 
1.4.17. PRO 140_CD07 Study
CD07_TNBC study (open-label, two-part [Phase Ib: Up to 18 subjects; Phase II: 30 Subjects], 
multi-center) seeks to evaluate the efficacy, safety, tolerability and maximum tolerate dose 
(MTD) of leronlimab (PRO 140) when combined with carboplatin in patients with CCR5+ 
metastatic triple-negative breast cancer (mTNBC).
The study population includes patients with CCR5-positive, locally advanced or metastatic triple-
negative breast cancer (mTNBC) who are naïve to chemotherapy in metastatic setting but have 
been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line).
This clinical study is currently ongoing.
1.4.18. CD08_mCRC Study
CD08_mCRC study (open-label, 30 subjects, multi-center) seeks to evaluate the effect on overall 
response rate (ORR) of Leronlimab (PRO 140) when combined with Regorafenib in patients with 
CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC). 
The study population includes patients with CCR5+, Microsatellite Stable (MSS), metastatic 
Colorectal Cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-

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1.5
DOSE RATIONALE 
Leronlimab (PRO 140) is currently under development for the indication of HIV in combination 
with other antiretroviral agents or as single agent maintenance therapy for the treatment of only 
CCR5-tropic human immunodeficiency virus type 1 (HIV-1) infection. The safety profile of 
leronlimab (PRO 140) has been extensively evaluated in clinical trials of HIV-positive patients. 
PRO 140 has been administered intravenously or subcutaneously to more than 750 healthy and 
HIV-1 infected individuals in Phase I/II/III studies. The drug has been well tolerated following 
intravenous administration of single (or multiple) doses of 0.5 to 10 mg/kg or up to 700 mg 
weekly doses as subcutaneous (SC) injection. Overall, 324 subjects have been exposed to PRO 
140 350 mg SC weekly dose with the longest duration of exposure lasting 4 years. Similarly, more 
than 250 and 150 subjects have been exposed to PRO 140 525 mg and 700 mg SC weekly dose, 
respectively. No dose-proportional increases in incidence and severity of AEs were reported at 
the 700 mg dose compared to the 525 mg and 350 mg dose levels of PRO 140 (leronlimab). 
We anticipate a manageable safety profile with combination therapy since: 1) Leronlimab (PRO 
140) is not metabolized by the liver, and therefore may have the potential for a better tolerability 
profile than many of the existing small-molecule therapies; 2) Unlike small molecules, 
monoclonal antibodies are too large to be filtered by the kidneys and are not eliminated in the 
urine, except in pathologic conditions. If low molecular weight antibody fragments are filtered, 
they are usually reabsorbed and metabolized in the proximal tubule of the nephron. These
pharmacodynamic characteristics and current safety profile led to the selection of 350 mg of 
leronlimab (PRO 140) as the starting dose in combination with other chemotherapy agents.
Note: Based on successful safety data review for the first three subjects enrolled in CD07_TNBC 
Study in Cohort A (350 mg leronlimab SC weekly + AUC 5 Carboplatin every 3 weeks), dose 
escalation to proceed with enrollment of subjects under Cohort B (525 mg leronlimab SC weekly 
+ AUC 5 Carboplatin every 3 weeks). The similar dose change of Leronlimab in combination 
with other chemotherapy agents is now implemented under the current protocol version for the 
CD09_Basket Study.
1.6
RISKS / BENEFITS ASSESSMENT
1.6.1. Risks/Discomfort to Subjects and Precautions to Minimize Risk
Allergic Reaction
Leronlimab (PRO 140) belongs to the monoclonal antibody class of drugs. Monoclonal antibodies 
are sometimes associated with allergic reactions or flu-like reactions (such as fever, chills, and 
aches) or injection-site reactions. These events are usually of short duration if they occur at all. 
Severe allergic reactions, however, can be life-threatening. Although anaphylaxis has not been 
observed in prior trials of leronlimab (PRO 140), infusion of proteins always carries with it the 

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theoretical risk for anaphylactic shock. Accordingly, whenever leronlimab (PRO 140) is 
administered to subjects, there should be available and in place the procedures required to manage 
anaphylactic shock.
Immune Response
People who take leronlimab (PRO 140) or other monoclonal antibodies can also develop an 
immune response to leronlimab (PRO 140) that may affect their ability to receive monoclonal 
antibodies, or to benefit from diagnosis or therapy with a monoclonal antibody in the future.
Pregnancy
Risks to unborn babies are unknown at this time; pregnant females will be excluded from this 
study. Females of childbearing potential must have a negative pregnancy test prior to enrollment. 
Both male and female patients and their partners of childbearing potential must agree to use 
appropriate birth control methods throughout the study duration (excluding women who are not of 
childbearing potential and men who have been sterilized). 
Venipuncture
Blood sampling is required as part of the study protocol. Blood sampling carries a minimal risk of 
minor discomfort and the possibility of minor bruising at the site of the needle puncture and, 
rarely, the possibility of infection at the needle puncture site.
Core or excisional biopsy
A core or excisional biopsy may be necessary in order to evaluate the CCR5 receptor status of the 
cancer tumor by Immunohistochemistry (IHC) assay. This assay will be performed in archival 
tissue from previous biopsy specimens. If archival tissue is not available then, fresh core or 
excisional biopsy will be done. Serious complications related to core biopsy are rare. The 
commonest problem is bleeding, which is usually easy to control at the time of the procedure. 
Rarer complications of core biopsy include infection and abscess formation, pneumothorax, milk 
fistula formation, cosmetic deformity and seeding of tumor along the biopsy track. Compared to a 
needle biopsy, a surgical biopsy is more invasive, has a longer, more uncomfortable recovery time 
and has a higher risk of infection and bruising.
Unknown Risks
As with all research there is the remote possibility of risks that are unknown or that cannot be 
foreseen based on current information. 

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Theoretical risk for increased severity of West Nile virus infection
Individuals who lack a functional CCR5 gene are at increased risk for severe infection by West 
Nile virus [Thompson, 2009]. Because of this, treatment with CCR5 co-receptor antagonists poses 
a theoretical risk for increased severity of West Nile virus infection. However, this concern is 
mitigated by several factors. First, no increased risk was observed for individuals who possess 
one functional and one non-functional CCR5 gene, indicating that an intermediate amount of 
CCR5 is sufficient for defense against West Nile virus [Thompson, 2009]. Second, use of CCR5 
co-receptor antagonists is unlikely to completely abrogate CCR5 function, and there has been no 
association reported to date between CCR5 co-receptor use and severe West Nile virus. 
Additionally, leronlimab (PRO 140) weakly antagonizes the natural activity of CCR5 and thus is 
less likely to adversely affect immune function. However, patients enrolled in this study may have 
immune suppression from chemotherapy and therefore, DSMB and the investigators will be 
alerted to risks of West Nile infections. Furthermore, this has not been established to be a risk 
with maraviroc, the other FDA-approved anti-CCR5 drug already.
Collectively, the experience with both IV and SC, simulation modeling and the recent 
confirmation that a higher concentration of leronlimab (PRO 140) synthesized using a highly 
efficient CHO cell line can be conveniently and safely administered has resulted in the design of 
the current study. 
1.6.2. Intended Benefit for Subjects
This study provides an opportunity for subjects with CCR5 + locally advanced or metastatic solid 
tumors to have once weekly SC treatment with leronlimab (PRO 140) in combination with 
standard-of-care chemotherapy or radiotherapy. Subjects participating in the present study will 
contribute to the development of a drug which has the potential to become a treatment option for 
them and others in the future.

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2
STUDY OBJECTIVES
Primary Objective:
The primary objective of this study is to assess anti-tumor activity of Leronlimab (PRO 140) in 
the treatment of patients with CCR5+ locally advanced or metastatic solid tumors.
Secondary Objectives:
The secondary objectives of this study are: 
To collect further safety, tolerability and efficacy data.
To evaluate correlative studies for better treatment selection in future validation studies

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discretion) using the same method as at baseline. Tumor measurements will be done using 
RECIST v1.1.
Note: Subjects participating under Protocol version 1.0 received 350 mg of PRO 140. Dose was 
increased from 350 mg to 525 mg weekly under version 2.0 of this protocol.
Subjects enrolled under version 1.0 have the option of remaining on their current dose of 350mg 
or increasing their dose to 525 mg for the remainder of the trial.
3.1
STUDY CENTER
Up to 10 centers in the United States (US).
3.2
STUDY POPULATION
The target population for this study is subjects with histologically or cytologically confirmed 
diagnosis of CCR5+ locally advanced or metastatic solid tumors.
This will be a multicenter trial. A total of 30 subjects will be needed for this trial.
Eligibility will be evaluated by the study team according to the following criteria. Eligibility
waivers are not permitted. Subjects must meet all of the inclusion and none of the exclusion 
criteria to be registered to the study. 
3.3
ELIGIBILITY CRITERIA
3.3.1. Inclusion Criteria
Subjects are required to meet all of the following criteria for enrollment into the study:
1. Must have a histologically or cytologically  confirmed diagnosis of locally advanced 
or metastatic solid tumors:
a.
who have disease progression on standard therapy,
b. who are receiving a standard anticancer treatment but no subsequent approved 
treatment would be available upon progression,
c.
who are unable to receive standard therapy, or
d. for whom standard therapy does not exist.
2. Demonstrate CCR5 + by IHC (>10% of primary or metastatic tumor cells shows 
membranous staining and/or high predominance of CCR5+ tumor-infiltrating 
leukocytes completed at the reference laboratory of Dr. Hallgeir Rui at Medical 
College of Wisconsin). 

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Note: This test will be done as part of the pre-screening period. It will be performed in 
archival metastatic tissue. If archival tissue is not available then, fresh biopsy will be 
done.
3. Be willing to provide tissue from a newly obtained core or excisional biopsy of a 
tumor lesion (in case archival tissue is not available);
4. Patients must have measurable disease based on RECIST v1.1;
5.
6. Patients must exhibit a/an ECOG performance status of 0-1;
7. Life expectancy of at least 6 months;
8. Patients must have adequate organ and bone marrow function within 28 days prior to 
registration, as defined below:
absolute neutrophil coun
total bilirubin: within normal institutional limits;
(applicable to all patients, irrespective of liver disease or metastasis); and
creatinine: within normal institutional limits.
9. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered 
not clinically significant by the Principal Investigator.
10. Females of child-bearing potential (FOCBP) and males must agree to use two 
medically accepted methods of contraception with hormonal or barrier method of birth 
control, or abstinence, prior to study entry, for the duration of study participation and 
for 60 days after the last dose of study drug (Refer to Appendix 1). Should a female
patient become pregnant or suspect she is pregnant while participating in this study, 
she should inform her treating physician immediately. NOTE: A FOCBP is any 
woman (regardless of sexual orientation, having undergone a tubal ligation, or 
remaining celibate by choice) who meets the following criteria:
Has not undergone a hysterectomy or bilateral oophorectomy; and
Has had menses at any time in the preceding 12 consecutive months (and therefore 
has not been naturally postmenopausal for > 12 months).

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11. FOCBP must have a negative serum pregnancy test at Screening Visit and negative 
urine pregnancy test prior to receiving the first dose of study drug; and
12. Patients must have the ability to understand and the willingness to sign a written 
informed consent prior to registration on study.
3.3.2. Exclusion Criteria
Subjects meeting any of the following criteria will be excluded from enrollment:
1. Is currently participating and receiving study therapy or has participated in a study of 
an investigational agent and received study therapy or used an investigational device 
within 28 days prior to enrollment;
2. Patients who have a history of allergic reactions attributed to compounds of similar 
chemical or biologic composition to leronlimab (PRO 140) are not eligible;
3. Patients who have had prior exposure to CCR5 antagonists are not eligible;
4. Has known active central nervous system (CNS) metastases and/or carcinomatous 
meningitis. Note: Subjects with previously treated brain metastases may participate 
provided they are stable (without evidence of progression by imaging for at least four 
weeks prior to the first dose of trial treatment and any neurologic symptoms have 
returned to baseline), have no evidence of new or enlarging brain metastases, and are 
not using steroids for at least 7 days prior to trial treatment. This exception does not 
include carcinomatous meningitis which is excluded regardless of clinical stability;
5. Has a history or current evidence of any condition, therapy, or laboratory abnormality 
that might confound the results of the trial, interfere with the subject’s participation for 
the full duration of the trial, or is not in the best interest of the subject to participate, in 
the opinion of the treating investigator;
6. Has known psychiatric or substance abuse disorders that would interfere with 
cooperation with the requirements of the trial; and
7. Is pregnant or breastfeeding, or expecting to conceive or have children within the 
projected duration of the trial, starting with the pre-screening or screening visit 
through the duration of study participation.

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4
STUDY SCHEDULE
The total study duration for each subject consists of pre-screening, screening, treatment, and 
follow-up periods. A study flow diagram is presented in Figure 4-1.
(1) Pre-Screening Period: A separate Informed Consent Form (ICF) will be used for the pre-
screening. The pre-screening period is designed for evaluation of histologically or 
cytologically confirmed locally advanced or metastatic solid tumors and CCR5 positive 
status by Immunohistochemistry (IHC) assay. This assay will be performed in archival 
tissue from previous biopsy specimens. If archival tissue is not available then, fresh core 
or excisional biopsy will be done. If patient qualifies, then they will undergo full 
screening.
(2) Screening Period: Screening assessments will commence after obtaining signed informed 
consent, and will include review of medical and medication history, demographic 
information
and baseline disease characteristics, eligibility evaluation, physical 
examination, vital signs, height and weight, concomitant medications, electrocardiogram 
(ECG), tumor imaging assessment (prior imaging assessment within the last 3 months of 
the Screening Visit is acceptable), routine serum biochemical, hematologic, urinalysis, 
serum pregnancy (if applicable). These assessments must be conducted within 28 days of 
the first treatment visit.
(3) Treatment Period: Subjects who meet the eligibility criteria will have completed 
following evaluations and assessments before receiving treatment: a) review of medical 
and medication history; b) physical examination, vital signs and documentation of ECOG 
performance status; c) ECG; d) routine serum biochemical, hematologic, urine pregnancy 
(if applicable) and urine laboratory assessments. Additionally, a blood sample will be 
collected prior to treatment administration for CTC and CAML analysis.
Leronlimab (PRO 140) will be administered subcutaneously weekly by a licensed medical 
professional at clinic site or self-administered by subjects at home.
Note: All initial leronlimab (PRO 140) SC weekly injections must be administered at 
clinic. The remaining study treatment injections may be self-administered by subjects at 
home after proper training by a healthcare professional.
Subjects will be allowed to continue treatment until any one of the following occurs: 
progressive disease or unacceptable toxicity or withdrawal of consent.
(4) Follow-Up Period: An End of Treatment (EOT) visit will be conducted 30 (± 3) days 
after the last treatment visit (i.e., after last dose of leronlimab (PRO 140). Additionally, 
follow-up will be done for survival status, by clinic visits or phone or another method of 

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4.1
PRE-SCREENING PERIOD
4.1.1. Pre-Screening Visit
Sites are required to pre-screen subjects for study inclusion, evaluating CCR5 positive status by 
Immunohistochemistry (IHC) assay prior to performing a full screening visit. This assay will be 
performed in archival tissue from previous biopsy specimens. If archival tissue is not available 
then, fresh core or excisional biopsy will be obtained.
The subject will sign and date the pre-screening informed consent form (ICF) in-person or 
remotely prior to any study-related pre-screening procedures. The remote consenting will involve 
the site sending the pre-screening ICF to subject (via hard copy or email) to discuss the consent 
over the phone. The written informed consent must be signed and personally dated by the subject,
sent back to the site and will then be signed by the person who conducted the informed consent 
discussion. The consent process and discussion over the phone will be captured in the medical 
records. 
A unique identification number will be assigned to each subject who has provided written pre-
screening informed consent. The subject unique identification number will incorporate a three-
digit Study Center number (901, 902 or 903….) and a three-digit numeric ID assigned in 
successive order of entering the study after signing the pre-screening ICF at each center, 
beginning with 001 at each site (e.g. 901-001 or 902-001).
Subject Screening # :
XXX
-
YYY
XXX=Study Center
YYY=Subject Numeric ID
Once the pre-screening ICF has been signed, the following procedures and information will be 
obtained to confirm pre- eligibility including:
Review of prior medical records
CCR5+ status confirmed by archival or fresh biopsy from primary or metastatic site
A pre-screening log will be maintained to capture the following information:
Subject unique identification number
Patient initials
Date pre-screened
Initial eligibility
Date of re-consent (for the full consent form) or reason for ineligibility

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4.2
SCREENING PERIOD
4.2.1. Screening Visit (SV)
The subject (or Legally Acceptable Representative (LAR)) will sign and date the informed 
consent form (ICF) and Health Insurance Portability Accountability Act (HIPAA) authorization 
(according to site policy and practices) prior to any study-related procedures. All study centers 
will be instructed to maintain the study-specific screening and enrollment logs at their sites. If a 
subject initially fails to meet inclusion/exclusion criteria and is later reconsidered for 
participation, the subject will be re-consented and assigned a new unique identification number at 
the time of re-screening. Subjects who fail their first screening attempt may be re-screened a 
maximum of once and may be enrolled if they are found to meet all inclusion and no exclusion 
criteria when re-screened.
Once the Screening ICF has been signed, screening procedures and information will be obtained 
to confirm subject eligibility including:
Demographic information and baseline disease characteristics (see Section 7.3), 
Medical history (see Section 7.4),
Prior medications assessment (see Section 7.5), 
Vital Signs (see Section 7.6),
Body Weight & Height measurements (see Section 7.6),
Physical examination (see Section 7.7),
Eastern Cooperative Oncology Group (ECOG) Performance Review (see Section 7.8)
12-lead Electrocardiogram (see Section 7.9)
Tumor imaging assessment (see Section 7.15)
Note: Prior imaging assessment within the last 3 months of the Screening Visit is 
acceptable
Collection of lab specimens (see Section 7.11) for
o
Complete blood count
o
Biochemistry
o
Serum pregnancy test, for female subjects of childbearing potential.
o
Urine sample for urinalysis parameters

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All screening information will be fully documented in the subject’s medical records (i.e., source 
documents).
For consented subjects who do not meet eligibility criteria, a Screen Failure Case Report 
Form (CRF) will be completed. The Screen Failure CRF will contain the following 
details: the subject identification number, the date of ICF signature, demographic 
information (see Section 7.3), and the reason for screen failure. No additional information 
will be required for subjects who fail screening.
For consented subjects who meet eligibility criteria, all required screening information 
will be transcribed onto the appropriate page of the CRF.
4.3
TREATMENT PERIOD
Subjects who meet all eligibility criteria, as per data gathered from Screening Period are to be 
treated. All subjects who fail to meet eligibility criteria will be considered screen failure and exit 
the study without further evaluation
The maximum sample size for this study is 30 subjects that will be followed by treatment 
according to the schedule described above starting at Treatment Visit 1 (Week 1).
Treatment may continue until one of the following criteria applies:
Disease progression,
Intercurrent illness that prevents further administration of treatment,
Unacceptable adverse event(s), or
Withdrawal of consent
4.3.1. Treatment Period, T1 (Week 1)
The following assessments will be performed at the first treatment visit of the treatment period:
Concomitant medications assessment (see Section 7.5), 
Vital Signs and body weight measurement (see Section 7.6),
Physical examination, including evaluation of all body systems (see Section 7.7)
ECOG Performance Status (see Section 7.8)
12-lead Electrocardiogram (see Section 7.9)
Collection of lab specimens (see Section 7.11 ) for
o
Complete blood count

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o
Biochemistry
o
Urine pregnancy test, for female subjects of childbearing potential.
o
Urine sample for urinalysis parameters
o
CTC and CAML analysis
Note: Complete blood count, biochemistry and urinalysis can be performed within 
3 days prior to each visit.
Leronlimab (PRO 140) Administration (see Section 6.1.3)
Post Injection Site Evaluation (performed by Investigator) (see Section 7.13)
Toxicity assessment (see Section 7.10) and Review of Adverse Events (see Section 9)
Standard-of-care chemotherapy (see Section 7.17)
4.3.2. Treatment Period, T2 (Week 2) Onward
The following assessments will be performed at during the remaining visits during the treatment 
period:
Concomitant medications assessment (see Section 7.5), 
Vital Signs (see Section 7.6),
Body weight measurement on T4, T7, T10, and every 3 weeks after (see Section 7.6),
Physical examination, including evaluation of all body systems on T4, T7, T10, and every 
3 weeks after (see Section 7.7)
ECOG Performance Status on T4, T7, T10, and every 3 weeks after (see Section 7.8)
Collection of lab specimens (see Section 7.11 ) on T4, T7, T10, and every 3 weeks after
for
o
Complete blood count
o
Biochemistry
o
Urine pregnancy test, for female subjects of childbearing potential
o
Urine sample for urinalysis parameters
o
CTC and CAML analysis

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Note: Complete blood count, biochemistry and urinalysis can be performed within 
3 days prior to each visit.
Leronlimab (PRO 140) Administration (see Section 6.1.3)
Post Injection Site Evaluation (performed by Investigator) (see Section 7.13)
Toxicity assessment (see Section 7.10) and Review of Adverse Events (see Section 9)
Standard-of-care chemotherapy (See Section 7.17)
Tumor imaging assessments every 3 months or according to institution’s standard practice
Subjects will be allowed to continue treatment until any one of the following occurs: progressive 
disease or unacceptable toxicity or withdrawal of consent.
4.4
FOLLOW-UP PERIOD
Duration of Follow Up
An End of Treatment (EOT) visit will be conducted 30 (± 3) days after the last treatment visit 
(i.e., after last dose of leronlimab (PRO 140)).
All patients will be followed for adverse events for 30 days after last dose of leronlimab 
(PRO 140) or until the patient starts a new treatment, whichever occurs first.
Subjects who discontinue treatment for unacceptable adverse event(s) will be followed until 
resolution or stabilization of the adverse event (i.e. the grade is not changing).
If a subject stops treatment due to unacceptable adverse event(s) but has not demonstrated 
disease progression, then the subject will be followed with imaging studies every 9 weeks 
until the time of progression radiographically according to RECIST v1.1 criteria. In the event 
that a radiographic response is detected, then this event will be included as a response in the 
final analysis, and the time of progression used in calculation of the survival analysis.
Subjects will be followed up by clinic visits or phone call or another method of contact, for 
survival status every 3 months (±1 month) for 2 years after treatment discontinuation or until 
death, whichever occurs first.
4.4.1. End of Treatment Visit (EOT)
An EOT visit will take place 30 (± 3) days from the last treatment visit. 
The following assessments will be performed at the EOT visit:
Concomitant medications assessment (see Section 7.5), 
Review of Adverse Events (see Section 9)

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Vital Signs (see Section 7.6),
Physical examination, including evaluation of all body systems (see Section 7.7),
ECOG Performance Status (see Section 7.8),
12-lead Electrocardiogram (see Section 7.9),
Toxicity Assessment (see Section 7.10),
Collection of lab specimens (see Section 7.11) for
o
Complete blood count
o
Biochemistry
o
Urine sample for urinalysis parameters
o
CTC and CAML Analysis
Survival status (see Section 7.16)
4.4.2. Survival Follow-up Visits
Survival follow-up visits will be performed every 3 months (±1 month) for 2 years after treatment 
discontinuation or until death, whichever occurs first. Subjects will be followed up by clinic visits 
or phone call or another method of contact, for survival status. During the visit, the following 
assessments will be performed:
Survival status
Concomitant medications (limited to all subsequent anti-cancer treatments)
Toxicity assessment
Note: Subjects who discontinue treatment for unacceptable adverse event(s) will be 
followed until resolution or stabilization of the adverse event (i.e. the grade is not 
changing).
Tumor imaging assessment (see Section 7.15 and note below) 
Note: If a subject stops treatment due to unacceptable adverse event(s) but has not 
demonstrated disease progression, then the subject will be followed with imaging studies 
every 9 weeks until the time of progression radiographically according to RECIST v1.1 
criteria. In the event that a radiographic response is detected, then this event will be 
included as a response in the final analysis, and the time of progression used in 
calculation of the survival analysis.

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4.5
UNSCHEDULED VISITS
In the event that the subject will return to clinic at a time other than a regularly scheduled study
visit, the visit will be regarded as an unscheduled visit. Assessments at unscheduled visits are at 
the discretion of the Investigator. All pertinent findings, including adverse events or changes in 
medications, will be noted in the eCRF.
Any hospitalization or ER visits in between the scheduled visits should be promptly notified to 
the site staff. 

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5
SUBJECT COMPLETION,
WITHDRAWAL AND CRITERIA FOR 
STOPPING THE STUDY
A subject is considered to have completed the study once all survival follow-up visit assessments up 
to 2 years after treatment discontinuation have been performed or until death, whichever occurs 
first.
While subjects are encouraged to complete all study evaluations, they may withdraw from the study 
at any time and for any reason. Reasonable effort will be made to determine why any subject 
withdraws from the study prematurely. This information will be recorded. If a subject withdraws 
prematurely after dosing, subjects will be monitored until they are stable for discharge from the 
clinic. All data normally collected at the scheduled Post-Study (Follow-up) Visit should be recorded 
at the time of premature discontinuation.
5.1
REMOVAL OF SUBJECTS FROM STUDY TREATMENT AND/OR STUDY AS A WHOLE
Subjects can be taken off the study treatment and/or study as a whole at any time at their own 
request, or they may be withdrawn at the discretion of the investigator for safety, behavioral or 
administrative reasons. The reason(s) for discontinuation must be clearly documented on the 
appropriate eCRF and may include:
Subject voluntarily withdraws from treatment (follow-up permitted)
Subject withdraws consent (no follow-up permitted)
Subject is unable to comply with protocol requirements
Subject demonstrates disease progression
Subject experiences unacceptable toxicity
Treating physician determines that continuation on the study would not be in the subject’s 
best interest
Subject becomes pregnant
Subject develops a second malignancy that requires treatment which would interfere with 
this study
Subject becomes lost to follow-up (LTF)
If a subject fails to return for the scheduled study visit or is discontinued from the study, an 
attempt will be made to determine the reason(s). If the subject is unreachable by telephone, a 
registered letter will be sent to the subject requesting that he/she contact the clinic. 

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All patients with an ongoing SAE at the Post-Study (Follow-up) Visit (scheduled or premature) 
must be followed until the event is resolved (with or without sequelae) or deemed stable.
5.2
DATA COLLECTED FROM WITHDRAWN SUBJECTS
Every attempt should be made to collect follow-up information. The reason for withdrawal from 
the study will be recorded in the source documents and on the appropriate page of the CRF.
Before a subject is identified as lost-to-follow up, the site should make all reasonable efforts to 
contact the subject. These attempts must be documented and should include at a minimum one 
phone call and one certified letter. 
In the event that a subject is withdrawn from the study at any time due to an adverse event or 
SAE, the procedures stated in Sections 9.2 and 9.4 must be followed.
5.3
SCREEN FAILURES
A subject who signed a consent form, but did not meet the inclusion/exclusion criteria is 
classified as a screen failure. Subject number, demographics and reason for screen failure will be 
recorded.
In the event that a subject initially fails to meet inclusion/exclusion criteria and is later 
reconsidered for participation, will be re-consented and assigned a new screening number at the 
time of re-screening. Subjects who fail their first screening attempt may be re-screened again (i.e., 
up to two screenings) and may be enrolled if they are found to meet all inclusion and no exclusion 
criteria at the subsequent screening visit.

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Below are representative samples of the Investigational Product, FDP individual vial (Figure 6-1), 
syringe label (Figure 6-2), and kit labels (Figure 6-3) designated for use in this clinical protocol. 
Each kit contains two labeled vials and two syringe labels. 
Figure 6-1:
Investigational Product - Vial Label
Protocol: CD09_Basket
                              Kit No. xx
Subject No. _________       
Single use 3 mL vial contains 2.4 mL of PRO 140 (175 
mg/mL) solution for subcutaneous injection
Store at 2oC to 8oC (36oF to 46oF)
USE AS PER STUDY PROTOCOL
Caution: New Drug – Limited by Federal (or United States) 
Law to Investigational Use
CytoDyn Inc., Vancouver, WA, USA
Protocol: CD09_Basket
                                  Kit No. xx
Subject No. _________       
Single use 3 mL vial contains 2.4 mL of PRO 140 (175 
mg/mL) solution for subcutaneous injection
Store at 2oC to 8oC (36oF to 46oF)
USE AS PER STUDY PROTOCOL
Caution: New Drug – Limited by Federal (or United States) 
Law to Investigational Use
CytoDyn Inc., Vancouver, WA, USA
Figure 6-2:
Investigational Product - Syringe Label
Protocol: CD09_Basket                                                  Contents of Kit No. xxx
This syringe contains 1 mL, 1.5 mL, 2mL or 3 mL PRO 140 (175 mg/mL) 
solution for subcutaneous injection
USE AS PER STUDY PROTOCOL
Caution: New Drug – Limited by Federal (or United States) Law to 
Investigational Use
CytoDyn Inc., Vancouver, WA, USA

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Figure 6-3:
Investigational Product - Kit Label
Protocol: CD09_Basket                                                                 Kit No. xxx
Site No. ____________             Subject No. ________________
This kit contains XX single-use vials
Each 3 mL vial contains 2.4 mL of PRO 140 (175 mg/mL) solution for 
subcutaneous injection
Store at 2oC to 8oC (36oF to 46oF)
USE AS PER STUDY PROTOCOL
Caution: New Drug – Limited by Federal (or United States) Law to Investigational 
Use
CytoDyn Inc., Vancouver, WA, USA
The pharmacy manual provides the criteria regarding vial acceptance or rejection, as well as 
instructions for the preparation of the IP syringes to be used to administer drug. 
6.1.2. Leronlimab (PRO 140) - Storage and Handling
Study drug will be shipped at 2°C to 8°C (refrigerated [36°F to 46°F]) to the investigator’s site. 
Upon receipt at the site, the responsible site staff or pharmacist should verify the integrity of the 
vials. Study drug should be stored at 2°C to 8°C (refrigerated [36°F to 46°F]). The contents of the 
vial should appear as a clear to opalescent, colorless to yellow solution; fine translucent particles 
may be present. This is normal. 
The investigator must maintain an accurate record of the shipment, storage, and dispensing of the 
study drug in a drug accountability log. An accurate record including the date and amount of 
study drug dispensed to each subject must be available for inspection at any time. A study CRA 
assigned to monitor the investigational site will review these documents once study drug has been 
received by the investigational site. Study drug will be accounted for on an ongoing basis during 
the study.
6.1.3. Leronlimab (PRO 140) - Administration
Guidelines for dose preparation can be found in the pharmacy manual.
Leronlimab (PRO 140) will be provided to the administering personnel in single-use syringes 
prepared from vials of study drug stored at 2-8°C at the site pharmacy prior to use. 

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7
DESCRIPTION OF PROTOCOL ASSESSMENTS AND PROCEDURES
7.1
INFORMED CONSENT
A written informed consent will be obtained for this study for pre-screening and screening by the 
Investigator or designee from all subjects prior to performance of any protocol-specific procedure. 
This study will be conducted in accordance with the provisions of the Declaration of Helsinki. 
The Investigator must comply with applicable regulatory requirements and must adhere to the 
Good Clinical Practice (GCP) in the process of obtaining and documenting the informed consent.
The Investigator, or designee, must also inform subjects of all pertinent aspects of the study. 
Before written informed consent is obtained from the subject, the Investigator or a person 
designated by the Investigator, must provide the subject enough time and opportunity to inquire 
about the details of the study and to decide whether or not to participate in the trial. All questions 
addressed by the subject about the study must be answered to the satisfaction of the subject. Prior 
to the subject’s participation in the trial, the written informed consent must be signed and 
personally dated by the subject and by the person who conducted the informed consent 
discussion. Authorization for release of protected health information must also be obtained, as per 
local policies.
7.2
ASSESSMENT OF ELIGIBILITY
The Investigator must assess subject’ continued eligibility for the study as per the Inclusion and 
Exclusion criteria, during the Screening Period. The eligibility criteria are described in Section
3.3.1 (Inclusion Criteria) and Section 3.3.2 (Exclusion Criteria). In the event that the subject is not 
suitable or eligible for the study, the subject will be considered “screen failure”.
7.2.1. Re-screening
If a subject fails initially to meet the eligibility criteria, and is later reconsidered for participation, 
the subject will be re-consented and assigned a new screening number at the time of re-screening. 
Subjects who fail their first screening attempt may be re-screened a maximum of once and may be 
enrolled in the study only if they meet all Inclusion and no Exclusion criteria when re-screened.
7.3
DEMOGRAPHIC INFORMATION AND BASELINE DISEASE CHARACTERISTICS
In this study the demographic information will include:
Dates of ICF signature 
Date of birth
Gender

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Race (American Indian/Alaskan Native, Asian, Black/African American, Native 
Hawaiian/Pacific Islander, Caucasian, or other)
Ethnicity (Hispanic/Latino or Not Hispanic/Latino)
In addition, the following baseline disease characteristics will be collected:
Year of initial diagnosis,
Tumor morphology (Ductal/NOS, Lobular, Medullary, Tubular, Other, or Unknown), 
Histologic grade (I, II, III, or Unknown),
Menstrual status,
Location of metastasis (Brain, Visceral, Nonvisceral)
7.4
MEDICAL HISTORY
A complete review of the subject’s past medical history, past surgeries, and current therapies 
(medications and non-medications) will be undertaken by the Investigator to check that all 
inclusion and no exclusion criteria have been met.
Events that emerge prior to the first treatment will be recorded in the medical history and not as 
AEs. Aside from being used to determine subject eligibility, this information will permit the 
Investigator to record the nature, duration and severity of any ongoing baseline medical 
conditions prior to the subject’s receiving investigational product treatment. 
Medical histories will be recorded using the body system categories outlined below:
Cardiovascular
Lymphatic
Respiratory
Hematologic
Gastrointestinal
Immunologic
Renal
Dermatologic
Hepatic
Psychiatric
Neurological
Genitourinary
Endocrine
Other
For each relevant history, the following will be documented: 
Disease/disorder/condition
Date of diagnosis
History status (resolved or ongoing).

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7.5
CONCOMITANT MEDICATION
The subject may be applied any medications judged necessary by the Investigator, provided such 
medications are not listed in Section 7.5.2.
All concomitant medication administered or taken by the subject beginning 30 days prior to 
Screening Visit and throughout the study will be recorded in the source documents and on the 
appropriate page of the Case Report Form (CRF) including all prescription, over-the-counter 
(OTC), herbal supplements, and IV medications and fluids. If changes occur during the trial 
period, documentation of drug dosage, frequency, route, and date may also be included on the 
CRF.
Subjects must be questioned at each study visit concerning any new medications or changes in 
current medications including over-the-counter medication and topical medication.
For each medication and non-study treatment, the following will be documented:
Medication/treatment name (generic name may be used if trade name is unknown)
Dose, unit, and frequency of dosing (individual dosages, not total daily dose). 
Note: Each new dose of medication should be recorded as a separate entry, with the 
exception of medications that are given on a sliding scale. For these, it is acceptable to 
enter the range of the dosage, including the start and stop dates for which the specified 
dosage range was used.
Route of dosing
Indication for use
The start date 
The stop date (if medication/therapy is not ongoing).
7.5.1. Permitted Medications
All treatments that the investigator considers necessary for a subject’s welfare may be 
administered at the discretion of the investigator in keeping with the community standards of 
medical care. 
7.5.2. Prohibited Medications
Subjects are prohibited from receiving the following therapies during the Screening and 
Treatment Period of this trial:

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Investigational agents other than leronlimab (PRO 140)
7.6
VITAL SIGNS, HEIGHT AND WEIGHT
The following will be collected: 
Vital signs:
o
Seated blood pressure (taken after the subject has been seated for at least 5 
minutes)
o
Pulse
o
Temperature (oral or tympanic)
o
Respiratory Rate
Height (at Screening Visit only) and Weight 
BMI (derived from the height and weight measurements).
7.7
PHYSICAL EXAMINATION
The physical examination will include routine examinations for the following:
Head, Ears, Eyes, Nose, Throat (HEENT)
Abnormalities of the extremities
Neurologic abnormalities
Heart/cardiovascular abnormalities
Musculoskeletal abnormalities
Dermatologic abnormalities
Any other body system for which an abnormality is noted and which, in the opinion of the 
Investigator, is relevant to the safety of the subject or could impact safety or efficacy 
results for the subject; i.e., the abnormality is clinically significant. 
Each abnormality will be recorded and the Investigator will record an assessment of its clinical 
significance. 
7.8
ECOG PERFORMANCE STATUS
The Eastern Cooperative Oncology Group (ECOG) performance status will be documented at the 
Screening Visit (SV), at the first treatment visit (T1) and every 3 weeks thereafter, and at End of 
Treatment (EOT) visit. 

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FedEx shipping address:
Hallgeir Rui MD, PhD
Medical College of Wisconsin
TBRC-4, C4980
8701 Watertown Plank Rd Milwaukee, WI 53226
(Ph: 414-955-2110)
For CTC and CAML analysis 
Creatv MicroTech, Inc
Daniel Adams
9 Deer Park Drive, Suite M-5
Monmouth Junction, NJ 08853
Tel 617-794-0213 (mobile)
Dan@creatvmicrotech.com
7.11.1.3 Assay Methodology
CTCs and CAML using CellSieve™
The CellSieveTM microfiltration assay isolates circulating tumor cells (CTCs) and circulating 
cancer-associated macrophage-like cells (CAMLs) by size exclusion, identifying CTCs and 
CAMLs by their morphological features and the phenotypic expression of CCR5, cytokeratins 8, 
18, and 19, CD45 and DAPI.  Peripheral blood (7.5 mL) collected in CellSave preservative tubes 
is prefixed for 15 min, placed into the 30-mL syringe, and drawn through the filter in 
3 min. 
The filtration instrument utilizes negative pressure to draw the sample through the filters at a 
gentle continuous rate.  The filter is then washed, postfixed, and permeabilized for 15 min. The 
filter and cells are stained with an antibody mixture and blocking buffer of FITC-conjugated anti-
cytokeratin 8, 18, 19, phycoerythrin (PE)-conjugated CCR5, and Cyanine5-conjugated CD45 
(Creatv MicroTech, Inc.). 
CTCs are CD45 negative cells with a pleomorphic nucleus and a filamentous cytokeratin positive 
phenotype. CAMLs are large (21–
CAMLs are identified as single cells with an enlarged nuclear profile (14–
separated polymorphic nuclei contained within the cell. In addition, the nuclei are surrounded by 
a larger CD45 signal. CAMLs can be identified further by vacuoles containing DAPI+ and/or 
cytokeratin.
7.12 STUDY TREATMENT APPLICATION
Refer to Section 6.1 for details.

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7.13 POST-INJECTION EVALUATION AND INJECTION SITE REACTION ASSESSMENT
At each treatment visit, an injection site reaction assessment will be made for the current and 
previous injection sites. Injection site reaction assessments are recorded by the Investigator 
starting after the first injection is given. Subject will be observed at approximately 30 minutes 
post-injection or longer if necessary for injection site reaction as per CTCAE v5.0. Refer to 
Sections 9.2.6 for more details.
7.14 PAIN NUMERIC RATING SCALE
Pain will be assessed using a 10-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain 
and 10 pain as bad as you can imagine
Figure 7-1:
Numeric Rating Scale
7.15 TUMOR IMAGING AND RESPONSE EVALUATION
For the purposes of this study, patients should be re-evaluated for tumor response approximately 
every 3 months or according to institution’s standard practice. In addition to a baseline scan, 
confirmatory scans should also be obtained 6 weeks following initial documentation of objective 
response greater than Stable Disease (SD).
Response and progression will be evaluated in this study using the new international criteria 
proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline 
(version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions
and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
High resolution CT with oral/intravenous contrast or contrast-enhanced MRI is the preferred 
imaging modalities for assessing radiographic tumor response. If a subject has a known allergy to 
contrast material, please use local prophylaxis standards to obtain the assessment with contrast if 
at all possible, or use the alternate modality. In cases where contrast is strictly contraindicated, a 
non-contrast scan will suffice. Screening assessments should be performed within 28 days of 
registration. Brain MRI is the preferred imaging method for evaluating CNS metastasis, and 

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assessment is required during screening in all eligible subjects. All known or suspected sites of 
disease (including CNS if history of CNS metastases) should be assessed at screening and at 
subsequent assessments using the same imaging method and technique. If more than one method 
is used at screening, then the most accurate method according to RECIST v1.1 should be used 
when recording data, and should again be used for all subsequent assessments. Previously treated 
CNS metastases are not considered measurable lesions for purposes of RECIST determined 
response. Subjects with a history of brain metastasis should have surveillance MRI approximately 
every 12 weeks, or sooner if clinically indicated.
Radiographic tumor assessments will be conducted approximately every 3 months or according to 
institution’s standard practice by CT or MRI (per treating investigator’s discretion); the same 
modality used at baseline should be used throughout. Tumor measurements will be done using 
RECIST v1.1. Tumor assessments for all subjects should continue as per protocol even if dosing 
is interrupted. Tumor measurements should be made by the same investigator or radiologist for 
each assessment whenever possible. Changes in tumor measurements and tumor responses to 
guide ongoing study treatment decisions will be assessed by the investigator using RECIST.
7.15.1. Definition of Lesions
Tumor response will be assessed according to the RECIST (version 1.1; Eisenhauer et al. 2009). 
At baseline, tumor lesions/lymph nodes will be categorized measurable or non-measurable as 
follows:
Measurable disease
Measurable lesions are defined as those that can be accurately measured in at least one dimension 
-
CT scan, MRI, or calipers by clinical exam (such measurements must be clearly documented). All 
tumor measurements must be recorded in millimeters (or decimal fractions of centimeters).
Malignant lymph nodes:
axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 
mm). At baseline and in follow-up, only the short axis will be measured and followed.
Non-measurable disease
All other lesions (or sites of disease), including small lesions (longest diameter < 10mm or 
pathological lymph no
as truly non-measurable lesions.

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Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis 
cutis/pulmonitis, inflammatory breast disease, and abdominal masses (not followed by CT or
MRI), are considered as non-measurable.
Special considerations regarding lesion measurability
Bone lesions, cystic lesions, and lesions previously treated with local therapy require particular 
comment:
Bone lesions:
Bone scan, PET scan or plain films are not considered adequate imaging techniques to 
measure bone lesions. However, these techniques can be used to confirm the presence or 
disappearance of bone lesions.
Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, that 
can be evaluated by cross sectional imaging techniques such as CT or MRI can be considered 
as measurable lesions if the soft tissue component meets the definition of measurability 
described above.
Blastic bone lesions are non-measurable.
Cystic lesions:
Lesions that meet the criteria for radiographically defined simple cysts should not be 
considered as malignant lesions (neither measurable nor non-measurable) since they are, by 
definition, simple cysts.
‘Cystic lesions’ thought to represent cystic metastases can be considered as measurable 
lesions, if they meet the definition of measurability described above. However, if noncystic 
lesions are present in the same patient, these are preferred for selection as target lesions.
Lesions with prior local treatment:
Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-
regional therapy, are usually not considered measurable unless there has been demonstrated 
progression in the lesion. Study protocols should detail the conditions under which such 
lesions would be considered measurable.
7.15.2. Method of Assessment
The same method of assessment and the same technique have to be used to characterize each 
identified and reported lesion at screening, at end of treatment and during follow-up.

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Clinically detected lesions will only be considered measurable when they are superficial (e.g., 
skin nodules and palpable lymph nodes).
Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and 
surrounded by aerated lung. However, CT is preferable.
Conventional CT and MRI should be performed with contiguous cuts of 5 mm or less in slice 
slice thickness, if the slice thickness is > 5 mm].
Ultrasound may only be used as a possible alternative to clinical measurements for superficial 
palpable lymph nodes, subcutaneous lesions, and thyroid nodules.
7.15.3. Baseline documentation of ‘target’ and ‘non-target’ lesions
Only subjects with measurable disease at baseline should be enrolled in this study. For evaluation 
of tumor response, lesions present at screening will be separated into target and non-target lesions 
according to the following criteria:
Target Lesions:
All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, 
representative of all involved organs, should be identified as target lesions and recorded and 
measured at baseline. 
Target lesions should be selected on the basis of their size (lesions with the longest diameter), 
be representative of all involved organs, but in addition should be those that lend themselves 
to reproducible repeated measurements. It may be the case that, on occasion, the largest lesion 
does not lend itself to reproducible measurement in which circumstance the next largest lesion 
which can be measured reproducibly should be selected.
A sum of the diameters (longest for non- nodal lesions, short axis for nodal lesions) for all 
target lesions will be calculated and reported as the baseline sum diameters. This is the “sum 
of the longest diameters” (SLD). If lymph nodes are to be included in the sum, then only the 
short axis is added into the sum. The baseline sum diameters will be used as reference to 
further characterize any objective tumor regression in the measurable dimension of the 
disease.
Non-Target Lesions 
All other lesions (or sites of disease) including any measurable lesions over and above the 5 
target lesions should be identified as non-target lesions and should also be recorded at 
baseline. Measurements of these lesions are not required, but the presence, absence, or in rare 
cases unequivocal progression of each should be noted throughout follow-up.

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Table 7-5:
Time point response: subjects with target (± non-target) disease
Target lesions
Non-target lesions
New lesions
Overall response
CR
CR
No
CR
CR
Non-CR/non-PD
No
PR
CR
Not evaluated
No
PR
PR
Non-PD or not all 
evaluated
No
PR
SD
Non-PD or not all 
evaluated
No
SD
Not all evaluated
Non-PD
No
NE
PD
Any
Yes or No
PD
Any
PD
Yes or No
PD
Any
Any
Yes
PD
CR = complete response, PR = partial response, SD = stable disease, PD = progressive 
disease, and NE = inevaluable.
Note: To be assigned a status of PR or CR, changes in tumor measurements must be 
confirmed by repeat assessments that should be performed 6 weeks after the criteria 
for response are first met. In the case of SD, measurements must have met the SD 
criteria at least once after study entry at a minimum interval of 6 weeks.
7.15.7. Duration of Response
Duration of overall response: The duration of overall response is measured from the time 
measurement criteria are met for CR or PR (whichever is first recorded) until the first date that 
recurrent or progressive disease is objectively documented (taking as reference for progressive 
disease the smallest measurements recorded since the treatment started).
The duration of overall CR is measured from the time measurement criteria are first met category 
when no lesions can be measured is not advised for CR until the first date that progressive disease 
is objectively documented.
Duration of stable disease: Stable disease is measured from the start of the treatment until the 
criteria for progression are met, taking as reference the smallest measurements recorded since the 
treatment started, including the baseline measurements.

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7.16 SURVIVAL STATUS
Subjects will be followed up by clinic visits or phone call or another method of contact, for 
survival status every 3 months (±1 month) for 2 years after treatment discontinuation or until 
death, whichever occurs first. 
7.17 STANDARD OF CARE
The standard of care should be administered as per the dosing schedule included on the package 
insert. 

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8
STATISTICAL ANALYSIS 
This section presents general information about statistical considerations and concepts and a brief 
discussion on analysis methodology, as well as some data conventions. Detailed descriptions of 
the statistical analysis methods and data conventions that will be used in this study will be in a 
separate document; i.e., the Statistical Analysis Plan (SAP).
8.1
TREATMENT GROUPS
525 mg leronlimab (PRO 140)
8.2
SAMPLE SIZE DETERMINATION AND RATIONALE
Up to 30 subjects will be enrolled in this study. The sample size for is based on clinical judgment. 
No statistical power calculation is used to establish the sample size.
8.3
RANDOMIZATION AND STRATIFICATION
Not applicable.
8.4
BLINDING
Not applicable. 
8.5
INTERIM ANALYSIS
No Interim Analysis (IA) will be performed for efficacy.
8.6
STATISTICAL CONSIDERATIONS
All collected study data will be presented in subject data listings. Statistical analyses will be 
performed using SAS® for Windows, version 9.4 or later. Descriptive statistics (n, mean, standard 
deviation, median, minimum and maximum) will be presented by treatment group for continuous 
variables. Frequencies and percentages will be presented by treatment group for categorical 
variables.
8.6.1. Analysis Populations
8.6.1.1
Evaluable Population
The Evaluable population is defined as the set of subjects who have received at least one dose of 
leronlimab (PRO 140) and have measurable disease at baseline. This population will be used for 
the analysis of efficacy parameters or measurements

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8.6.1.2
Per Protocol Population
The Per Protocol (PP) population is defined as the set of subjects who meet the Evaluable 
Population requirements and were not associated with any major protocol violations. This 
population will be identified before the database lock.
The PP analysis of primary and secondary endpoints will be considered supportive
8.6.1.3
Safety Population
The Safety Population will include all subjects who have received one dose of leronlimab (PRO 
140). This population will be used for the analysis of safety parameters.
8.6.2. Covariates
For efficacy analyses, the baseline values will be used as covariates in the analysis models. Other 
important prognostic factors will be specified in the SAP for the study.
8.6.3. Missing Data
All data will be used as observed, and no imputations will be made for any missing data point for
early phase study.
8.7
ANALYSIS METHODS
A SAP will be developed and approved before the database is locked. The SAP will present the 
detailed statistical methodology to be used in analyzing the data from this trial.
8.7.1. Subject Disposition
The disposition of all subjects who sign an ICF will be provided. The numbers of subjects 
screened, enrolled, completed, and discontinued during the study, as well as the reasons for all 
post-enrollment discontinuations will be listed and/or summarized by treatment group. 
Disposition and reason for study discontinuation will also be provided as a by-subject listing.
8.7.2. Demographic and Baseline Disease Characteristics
Demographics and baseline disease characteristics including medical history, prior and 
concomitant medications/therapies will be listed and/or summarized by treatment group using 
appropriate descriptive statistics.
8.7.3. Study Analyses
Safety Outcome Measures:
The safety outcome measures in this study are:

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The number, frequency, and severity of adverse events (AEs) collected from the time of 
first treatment until 12 weeks after study treatment completion to evaluate safety of 
leronlimab (PRO 140) in subjects with CCR5+ locally advanced or metastatic solid 
tumors.
Note: Adverse events will follow National Cancer Institute Common Terminology Criteria 
for Adverse Events (CTCAE) version 5.0
Laboratory data changes from baseline to subsequent scheduled visits
Changes in physical examinations from baseline to subsequent scheduled visits
Changes in vital signs from baseline to subsequent scheduled visits.
Changes in Eastern Cooperative Oncology Group (ECOG) performance status from 
baseline to subsequent scheduled visits.
Changes of electrocardiogram (ECG) results from baseline to subsequent scheduled visits
Efficacy Outcome Measures:
The efficacy outcome measures in this study are:
Progression free survival (PFS) defined as time in months from the date of first study 
treatment to the date of disease progression or death from any cause, whichever comes 
first.
Note: All patients who receive at least one dose of leronlimab (PRO 140) will be included 
in the primary analyses of PFS. The Response Evaluation Criteria in Solid Tumors 
(RECIST v1.1) criteria will be used for objective tumor response assessment (when 
disease is measurable and non- measurable);
The time in months from start of treatment to progression or death will be measured for 
all patients who receive at least one dose of study drug. Patients will be followed up to 2 
years after completion of treatment.
Overall response rate (ORR, defined as Complete Response (CR) + Partial Response 
(PR)), and clinical benefit rate (CBR, defined as CR + PR + Stable Disease (SD)) in 
subjects with CCR5+ locally advanced or metastatic solid tumors treated with leronlimab
(PRO 140).
Note: Overall response rate is defined as the proportion of patients who achieve an 
overall response of complete response or partial response in the total number of evaluable 
patients, assessed by RECIST v1.1. Clinical benefit rate is defined as the proportion of 
patients who achieve an overall response of complete response or partial response or 
stable disease in the total number of evaluable patients, assessed by RECIST v1.1. 

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Descriptive statistics (n, mean, standard deviation, median, minimum, and maximum) will be 
calculated for continuous variables. Frequencies and percentages will be presented for categorical 
variables.
Adverse Events:
Adverse events will be coded using the most recent version of Medical Dictionary for Regulatory 
Activities (MedDRA). Treatment Emergent AE’s (TEAE) are defined as events with an onset on 
or after the first treatment. TEAEs will be summarized by study phase, treatment group, System 
Organ Class, and preferred term. The following TEAE summaries will be provided:
Overall (i.e., regardless of severity or relationship to treatment)
By severity grade (mild, moderate, severe, or life threatening for SAEs)
By relationship to clinical trial treatment according to the mapping scheme below:
o
Potentially related: will include all adverse events with a relationship rating of 
“definitely”, “probably” or “possibly”. 
o
Unlikely/not related: will include all adverse events with a relationship rating of 
“unlikely” or “unrelated”.
In addition, separate summaries of serious adverse events, and adverse events resulting in 
discontinuation of study treatment will be presented.
Clinical Laboratory Data
All laboratory values will be listed. Laboratory measurements will also be summarized as 
continuous variable and presented by treatment group and time point. 
Physical Examination 
All physical examination findings will be listed and/or summarized. 
Vital Signs
All vital sign findings will be listed and summarized. 
Electrocardiograms (ECGs)
All ECG findings will be listed and summarized. 
Eastern Cooperative Oncology Group (ECOG) performance status
All ECOG performance status findings will be listed and summarized. 

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9
ADVERSE EVENTS (DEFINITIONS AND REPORTING)
The Investigator is responsible for the detection and documentation of events meeting the criteria 
and definition of an AE or SAE, as provided in this protocol. During the study when there is a 
safety evaluation, the Investigator or site staff will be responsible for detecting, documenting and 
reporting AEs and SAEs as detailed in this Section of the protocol. 
9.1
ADVERSE EVENT (AE)
An adverse event (AE) is defined as any unfavorable or unintended sign, symptom, or disease that 
occurs or is reported by the subject to have occurred, or a worsening of a pre-existing condition. 
An adverse event may or may not be related to the study treatment. 
AEs will be elicited through direct questioning and subject reports. Any abnormalities in visit 
evaluations, physical examination findings or laboratory results that the investigator believes are 
clinically significant to the research subject and that occurred after initiation of the first study 
treatment will be reported as AEs. Abnormal findings that are NOT clinically significant should 
not be recorded as an AE.
9.2
REPORTING AND FOLLOW-UP OF ADVERSE EVENTS
Report initiation for all AEs and serious adverse events (SAEs), (see Section 9.3), will begin at 
the time of the first treatment and continue up to the final study visit. All events will be followed 
to resolution or until 30 days after the subject completes the study. A final assessment of outcome 
will be made at that time.
All AEs must be recorded in the subject’s medical records and on the CRF. AEs will be reported 
using customary medical terminology along with the following information: the onset and end 
dates, whether the event is considered to be a SAE (see Section 9.3), the impact the event had on 
study treatment (see Section 9.2.1), the CTCAE grade (intensity) of the event (see Section 9.2.2), 
the causality of the event (see Section 9.2.3), whether treatment was given as a result of the event 
(see Section 9.2.4), and the outcome of the event (see Section 9.2.5).
9.2.1. Impact on Study Treatment
The impact the event had on the study treatment will be assessed as either: none, study treatment 
interrupted, study treatment discontinued, or not applicable. The “not applicable” assessment will 
be used only when the subject is no longer in the treatment period of the protocol or died.
9.2.2. CTCAE Grade (Intensity) Assessment
The guidelines outlined in CTCAE v5.0 will be used for assessing the intensity of the event. The 
general guidelines for assessing the AE grade appear below. Full guidelines may be obtained at 

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5. Definitely – The event follows a reasonable temporal sequence from the study biologic or 
control, abates upon discontinuation and cannot be explained by known characteristics of 
the patient’s clinical state.
9.2.4. Treatment Given as a Result of the Event
The event impact in terms of treatment provided will be as either: none, medication administered, 
non-drug therapy administered, surgery performed, hospitalization, or other (with a specification).
9.2.5. Outcome Assessment
The outcome of the event will be assessed as either: resolved, resolved with sequelae, ongoing, or 
death. Only one AE per subject is allowed to have an outcome assessment as “death.” If there are 
multiple causes of death for a given subject, only the primary cause of death will have an outcome 
of death. 
9.2.6. Injection-site reactions
Injection-site reactions thought to be directly related to the injection are considered to be AEs of 
special interest, and will be assessed as per CTCAE v5.0.
For subjects who develop Grade 1 or Grade 2 events, therapy will be continued as per protocol. If 
a subject chooses to discontinue study treatment, the site should notify the protocol team 
leadership, and encourage the subject to complete any remaining study visits until the toxicity 
resolves.
For subjects who develop Grade 3 events following study drug injection, the subject should be 
reevaluated closely until the AE returns to Grade 1 or less, at which time study treatment may be 
reintroduced at the discretion of the site investigator. If the same Grade 3 AE recurs following the 
next administration of study drug, study treatment must be permanently discontinued. Subjects 
experiencing Grade 3 AEs requiring permanent discontinuation of study treatment should be 
followed closely for resolution of the AE to Grade 1 or less and the team leadership must be 
notified.
For Grade 4 events permanently discontinue therapy. 
9.3
SERIOUS ADVERSE EVENTS
A SAE is defined as any AE that:
Results in death
Is life threatening (the subject is at immediate risk of dying from the adverse experience)
Requires subject hospitalization or prolongs existing hospitalization
Results in persistent or significant disability/incapacity 

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10 DIRECT ACCESS TO SOURCE DATA/DOCUMENTATION
Subjects will be identified on eCRFs by a unique subject identification number and on source 
documents by name and date of birth. No personal identifier will be used in any publication or 
communication used to support this research study. The subject identification number will be 
used if it becomes necessary to identify data specific to a single subject. 
The local IRB, FDA, the monitors, auditors and personnel authorized by the Sponsor are eligible 
to review the medical and research records related to this study as part of their responsibility to 
protect human subjects in clinical research. They will be given direct access to source data and 
documentation (e.g., medical charts/records, printouts etc.) for source data verification, provided 
that subject confidentiality is maintained in accordance with local requirements. Access to 
electronic medical records may be governed by institution policy and each site will be required to 
ensure access while remaining compliant with institutional requirements.

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11 QUALITY CONTROL AND QUALITY ASSURANCE
11.1 MONITORING REQUIREMENTS
The specific obligations outlined in 21 Code of Federal Regulations (CFR) and ICH guidelines 
require the Sponsor to maintain current personal knowledge of the progress of a study. Therefore,
the Sponsor's designated monitor will visit the site during the study as well as maintain frequent 
telephone and written communication. The Investigator will permit the Sponsor to monitor the 
study as frequently as is deemed necessary and provide access to medical records to ensure that 
data are being recorded adequately, that data are verifiable and that protocol adherence is 
satisfactory. 
As delineated above, the Investigator will permit representatives of the Sponsor and/or designated 
CRO to inspect all CRFs and corresponding study subject original medical records (source 
documents) at regular intervals throughout the study. Subject original medical records and other 
relevant data must be available to support all data recorded in the eCRF. In addition to the 
original medical records, these data may include but are not limited to study, laboratory reports, 
etc. 
In accordance with federal regulations, site inspections will serve to verify strict adherence to the 
protocol and the accuracy of the data that is being entered on the case report forms. A Monitoring 
Log will be maintained at each study site. The Monitoring Log will be signed by the monitor,
dated and stated the type of visit. The Investigator should be aware that the study site and subject 
records may be inspected by the Sponsor and or representatives of the designated CRO, FDA or 
other regional regulatory authority.
11.2 ACCEPTABILITY OF CASE REPORT FORMS (CRFS)
For each subject who has signed an informed consent form, a CRF must be completed. For 
subjects who are screen failures, this would be limited to the screen failure CRF page. All source 
documents and CRFs will be completed as soon as possible after the subject's visit and 
corrections to data on the CRFs will be documented, if applicable. The Investigator will review 
the CRFs to indicate that, to his/her knowledge, they are complete and accurate. CRFs will be 
reviewed by the Sponsor’s or designated CRO’s monitor, who will make a decision as to their 
acceptability.

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11.3 MODIFICATION OF PROTOCOL
The Investigator will not modify or alter this protocol without first obtaining the concurrence of 
the Sponsor. Approval by the Investigator’s IRB must also be obtained prior to implementation of 
the change, with two exceptions:
1. When necessary to eliminate apparent immediate hazard to the subject; or
2. When the modification does not involve the subject’s participation in the trial.
An amendment may also require modification of the informed consent form. The Investigator will 
provide an approval letter for the amendment and revised informed consent form, if applicable, to 
the Sponsor. An amendment must be provided in writing and it must be dated by both the Sponsor 
and the Investigator. If necessary, the Sponsor will submit protocol amendments to FDA and 
other appropriate regulatory authorities and notify other Investigators using this protocol.
11.4 REPORTING PROTOCOL DEVIATIONS
The Investigator is obligated to follow the protocol without departure from the requirements 
written in the protocol. If the Investigator deviates from the protocol requirements, the Sponsor 
will make the determination as to whether the subject will continue in the study. The Sponsor also 
has the right to discontinue the subject for protocol violations. The IRB may also have to be 
contacted if safety to the subject or if the scientific soundness of the study is involved. All 
protocol deviations must be documented in the CRFs.
11.4.1. Major Protocol Deviation or Violation
A major protocol deviation or violation is a deviation from the IRB approved protocol that may 
affect the subject's rights, safety, or well being and/or the completeness, accuracy and reliability 
of the study data. Examples of this include:
Failure to obtain informed consent prior to initiation of study-related procedures 
A research subject does not meet the protocol's eligibility criteria but was enrolled without 
prior approval from the sponsor.
A research subject received the wrong treatment or incorrect dose.
A research subject met withdrawal criteria during the study but was not withdrawn.
A research subject received a prohibited concomitant medication.
Failure to treat research subjects per protocol procedures that specifically relate to primary 
efficacy outcomes.
Changing the protocol without prior sponsor and IRB approval.

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Multiple minor violations of the same nature after multiple warnings.
11.4.2. Minor Protocol Deviation or Violation
A minor protocol deviation is any change, divergence, or departure from the study design or 
procedures of a research protocol that has not been approved by the IRB and which DOES NOT 
have a major impact on the subject's rights, safety or well-being, or the completeness, accuracy 
and reliability of the study data. Examples of this include:
Follow-up visits that occurred outside the protocol required time frame because of the 
participant’s schedule.
Blood samples obtained at times close to but not precisely at the time points specified in 
the protocol.

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12 DATA SAFETY MONITORING BOARD (DSMB)
The study will be monitored by an independent DSMB to ensure patient safety. The CRO is
responsible for the overall management of DSMB, including development of its charter and
membership selection. The DSMB will be managed in conformance with the FDA guidelines
for DSMB independence, management, and oversight.
The DSMB will consist of at least three members and will review unexpected AEs, related AEs, 
SAEs, and deaths, according to the study’s phase and risk level, as outlined in the DSMB 
charter.
All expedited safety reports will be provided in real time to the DSMB chair upon being 
reported to FDA.
Note: For the purpose of expedited safety reporting, all adverse events except skin reactions will 
be considered unexpected.
The DSMB will make the following recommendations at each safety evaluation:
Continue the study as planned;
Assess a specific aspect of safety that is not conclusive;
Gather more data to address a specific safety issue; and
Stop the study due to safety concerns.
Additionally, DSMB may recommend protocol modifications or other actions including but not 
limited to the following:
Discontinuing or modifying a study based on safety information obtained from the protocol 
or from information external to the trial
Changing the eligibility criteria if the risks of the intervention appear to be higher in a 
particular subset of patients
Altering the drug dosage and/or schedule if the adverse events observed appear likely to be 
mitigated by such changes
Instituting screening procedures that could identify those subjects at increased risk of a 
particular adverse event
Identifying information needed to inform current and future trial subjects of newly identified 
risks via changes in the informed consent document and, if appropriate, recommending re-
consent of current subjects to continue trial participation.

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The Sponsor retains the responsibility to contact FDA and the final decision regarding the
recommendation to continue or to terminate the study.

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13 ETHICS AND REGULATORY REQUIREMENTS
This study is to be conducted in accordance with the specifications of this protocol and in 
accordance with principles consistent with Declaration of Helsinki, GCP, 21 CFR, ICH E6, 
HIPAA regulations in 45 CFR Part 164 (US only), and the Belmont Principles of respect for 
persons, beneficence, and justice. No protocol changes will be implemented without the prior 
review and approval of the IRB, except when the modification does not involve the subject’s 
participation in the trial or where it may be necessary to eliminate an immediate hazard to a 
research subject. In the latter case, the change will be reported to the IRB as soon as possible, 
according to IRB regulations. 
Additionally, the study product used in this study is manufactured, handled and stored in 
accordance with applicable GMP. The study product provided for this study will be used only in 
accordance with this protocol.
13.1 INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
The Principal Investigator (PI) at the site will provide the Institutional Review Board/Independent 
Ethics Committee (IRB/IEC) with all appropriate materials as required by their IRB/IEC, 
including but not limited to the clinical study protocol, informed consent form, and any 
advertising materials. The study will not be initiated until the IRB/IEC provides written approval 
of the aforementioned documents and until approval documents have been obtained by the 
Principal Investigator and Sponsor or Sponsor designee. The Investigator will not participate in 
the decision. If the Investigator is an IRB or IEC member, documentation must be provided 
indicating recusal from the approval process. Appropriate reports on the progress of this study by 
the Principal Investigator will be made to the IRB/IEC as required by local and applicable 
government regulations and in agreement with policy established by the Sponsor. The 
Investigator is required to maintain an accurate and complete record of all written correspondence 
to and received from the IRB/IEC, and must agree to share all such documents and reports with 
the Sponsor.
No changes from the final approved protocol will be initiated without the IRB/IEC’s prior written 
approval or favorable opinion of a written amendment, except when necessary to eliminate 
immediate hazards to the subjects or when the modification does not involve the subject’s 
participation in the trial.
13.2 INVESTIGATOR’S RESPONSIBILITIES
The Investigators are responsible for performing the study in full accordance with the protocol 
and the current revision of the Declaration of Helsinki, the Good Clinical Practice: Consolidated 

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Guideline, approved by the ICH, and any applicable national and local laws and regulations. 
Information regarding to the study center participating in this study that cannot comply with these 
standards will be documented.
13.3 SUBJECT INFORMED CONSENT REQUIREMENTS
All subjects participating in this study will be given to by the Investigator and/or designee, written 
and oral information about the study in a language understandable by the subject. Written 
informed consent will be obtained from each subject prior any procedures or assessments that 
would not otherwise be required for the care of the subject are done and after the aims, methods, 
anticipated benefits, potential hazards, and insurance arrangements in force are explained and the 
subject has been given sufficient time to ask questions and consider participation in the study. It 
will also be explained to the subjects that they are free to refuse entry into the study and free to 
withdraw from the study at any time without prejudice to future treatment. It is permissible for a 
third person (e.g., a family member) to be present during the explanation of the study.
The written Informed Consent Form ICF will be in compliance with CFR 21 Part 50.27 and GCP 
guidelines. The Sponsor and/or designated CRO will approve the ICF and all amendments to the 
ICF prior to submission to the IRB/IEC. A copy of the ICF to be used will be submitted by the 
Investigator to the IRB/IEC for review and approval prior to the start of the study. The study site 
must provide the Sponsor with an unsigned copy of IRB/IEC-approved ICF along with applicable 
documentation to support this approval. The original signed ICF is retained in the subject's study 
records, and a copy is provided to the subject. A second copy may be filed in the subject’s 
medical record, if allowed by institutional policy. 

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14 DATA HANDLING AND RECORD KEEPING
14.1 RECORDING AND COLLECTION OF DATA
The primary source document for this study will be the subject's medical record. If separate 
research records are maintained by the Investigator(s), the medical record and the research 
records will be considered the source documents for the purposes of auditing the study. 
Applicable source data will be manually transcribed to approve case report forms (CRF). The 
Investigator is ultimately responsible for the accuracy of the data transcribed on the forms. All 
source documents and CRFs will be completed as soon as possible after the subject's visit.
The Investigator will review the CRFs to indicate that, to his/her knowledge, they are complete 
and accurate. Designated source documents will be signed and dated by the appropriate study 
personnel. The Investigator must agree to complete and maintain source documents and CRFs for 
each subject participating in the study.
All research data will be entered, either electronically or manually, into a computerized database. 
The clinical database will be designed by the clinical data manager in accordance with 21 CFR 
Part 11 and based on protocol requirements defined by the Sponsor in association with the Lead 
Investigator. 
The Investigator will maintain a confidential list of study subjects that will include each subject’s 
study number, name, date of birth, and unique hospital identification number if applicable. This 
list will be kept by the Investigator and will not be collected by the Sponsor. A notation will be 
made in the subject’s case history/medical chart that he/she is participating in a clinical study and 
has provided a signed and dated ICF as well as a release for protected health information as 
required by local policies. The Investigator must also maintain a separate screening log of all the 
subjects screened for participation in the study; it should include gender, age, eligibility status,
reason for ineligibility, if applicable; and study allocated subject number, if applicable. 
14.2 CLINICAL DATA MANAGEMENT
The Sponsor and/or designated CRO will be responsible for the processing and quality control of 
the data. Data management will be carried out as described in the Sponsor’s or CRO’s standard 
operating procedures (SOPs) for clinical studies.
The handling of data, including data quality control, will comply with regulatory guidelines 
(e.g., ICH E6 GCP, and local regulations where applicable) and the Sponsor’s or the CRO’s SOPs 
as well as provisions of the study-specific Data Management Plan.

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14.3 ARCHIVING
All study documentation at the Investigator site and Sponsor site will be archived in accordance 
with ICH GCP E6 and the Sponsor’s quality standards and SOPs.
The Investigator will maintain all research records, reports, and case history reports for a period 
of two (2) years after regulatory approval of the investigational product. If no application is filed 
or if the application is not approved, records must be maintained for two (2) years after all 
investigations have been completed, terminated or discontinued and the FDA has been notified. 
These documents should be retained for a longer period however, if required by the applicable 
regulatory requirements or if needed by Sponsor or its authorized representative (as per 
GCP 5.5.11).
At the completion of the study, details of the archival process must be provided to the Sponsor. 
Study records are subject to inspection by applicable health and regulatory agencies at any time. 
Records to be retained by the Investigator include, but are not restricted to:
Source data and the primary records upon which they are based (e.g., subject’s progress 
notes, adverse event data, test results, and any other diagnostic procedures required to 
evaluate the progress of the study)
Completed CRFs
Signed protocols and protocol amendments
Laboratory results, ranges, and certifications
IP and accountability records
Study personnel signature log
Monitoring logs
Correspondence to and from the Sponsor, designee and IRB
Investigator and sub-investigator CVs
Signed informed consent and protected health information consent forms
Subject screening 
SAE reports
IRB approval and re-approval letters
Completed quality of life questionnaire
Other documents pertaining to the conduct of the study
These documents must be maintained and kept on file by the Investigator so that the conduct of 
the study can be fully documented and monitored.

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Study records should not be transferred from site or destroyed without prior written agreement 
between the Sponsor and the study Investigator. Study records are subject to inspection by 
applicable health and regulatory agencies at any time. 

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15 PUBLICATION PLAN
All information supplied by CytoDyn in connection with this study and not previously
published, is considered confidential information. This information includes, but is not
limited to, the Investigator’s Brochure, clinical protocol, case report forms and other scientific
data. Any data collected during the study are also considered confidential. This confidential
information
shall remain the sole property of CytoDyn, shall not be disclosed to others
without the written consent of CytoDyn, and shall not be used except in the performance of this 
study.
It is understood by the Investigator that the Sponsor will use the information collected in this 
clinical trial in connection with the development of CytoDyn. Therefore, this information may be 
disclosed as required to other Investigators or appropriate regulatory authorities. By agreeing to 
participate in this clinical trial, the Investigator understands that he/she has an obligation to 
provide the Sponsor with complete test results and all data developed during this trial.
Publication and Disclosure: The site and Investigator agree to submit any proposed manuscript, 
presentation or other public disclosure regarding the study to Sponsor for review at least thirty 
(30) days prior to submitting such proposed manuscript to a publisher or delivering or making 
such presentation or other public disclosure to any third party. Within thirty (30) days of its 
receipt, Sponsor shall advise the site and/or Investigator, as the case may be, in writing of any 
information contained therein that is confidential information (other than research results included 
in a proposed manuscript) or that may impair Sponsor’s ability to obtain patent protection. 
Sponsor shall have the right to require the site and/or Investigator, as applicable, to remove 
specifically identified confidential information (but may not require removal of research results 
from a proposed manuscript) and/or to delay the proposed submission or delivery of the proposed 
manuscript or presentation, or other public disclosure, for an additional sixty (60) days to enable 
Sponsor to seek patent protection. The site and Investigator shall not publish, publicly disclose, 
present or discuss any results of or information pertaining to the site’s and Investigator’s activities 
prior to completion of the trial, even if the multi-center trial or the study is terminated before its 
completion and the final clinical study report is signed off, or with respect to any endpoints or 
analyses other than those specified in this protocol.

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16 REFERENCES
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17 APPENDIX
17.1 APPENDIX 1:
ACCEPTABLE METHODS OF CONTRACEPTION
Barrier Methods
Intrauterine Device Methods
Hormonal Methods
Male condom plus 
spermicide
Cap plus spermicide
Diaphragm plus 
spermicide
Copper T
Progesterone T
Levonorgestrel-releasing
Implants
Hormone shot or 
injection
Combined pill
Minipill
Patch
NOTE: choice of contraception should be discussed with primary treating oncologist to 
discuss the risks and benefits of different modalities of contraception.

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17.2 APPENDIX 2:
COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS V5.0
For complete detailed information please refer to the link below:
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Re
ference_8.5x11.pdf