Clinical trial NCT02280317
Conditions: Stage III Prostate Carcinoma Stage IV Prostate Carcinoma
Sponsor: ValiRx Plc
Start date: 2014-10-01; Completion date: 2020-01-27
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
Dose finding safety study of VAL201 in cancer patients.

Detailed description:
A Phase I/II, dose escalation study to assess the safety and tolerability of VAL201 in patients with locally advanced or metastatic prostate cancer and other advanced solid tumours.

Arms: arm 1: VAL201-001 Sub-cutaneous injection. 0.5 mg/kg arm 2: VAL201-001 Sub-cutaneous injection. 1.0 mg/kg arm 3: VAL201-001 Sub-cutaneous injection. 2.0 mg/kg arm 4: VAL201-001 Sub-cutaneous injection. 4.0 mg/kg arm 5: VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
Interventions: intervention 1: VAL201
Intervention descriptions: intervention 1: VAL201-001 Sub-cutaneous injection.

Protocol documents:
ICF_002.pdf: 
ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 1 of 17
<To be printed on hospital headed paper>
Study title: A Phase I/II, Dose Escalation Study to Assess the Safety and Tolerability of
VAL201 in Patients with Locally Advanced or Metastatic Prostate Cancer and Other
Advanced Solid Tumours
Dose finding safety study of VAL201 in cancer patients
PARTICIPANT INFORMATION SHEET AND CONSENT FORM
You are being invited to take part in a research study using an experimental (or investigational)
drug called VAL201.
Before you decide whether to take part, it is important for you to understand why the study is
being done and what it will involve.
Please take as much time as you need to read the following information carefully and discuss it
with friends, relatives and your GP if you wish. Please ask us if there is anything that is not clear
or if you would like more information. It is important that you take your time to decide whether
or not you wish to take part.
There are 2 parts to this document:

Part 1 - This is to tell you about the study (why it is being done, how it will be carried out,
possible benefits and potential risks of taking part) and what you will be expected to do.
It will also explain how your medical information will be used and who may see it. If
there is anything that is not clear or if you would like more information, you are free to
ask us as many questions as you like.

Part 2 – This provides more information on the study. If you agree to take part, you will
be asked to sign an Informed Consent Form. You are free to change your mind and
withdraw from the study at any time, without giving a reason.
A copy of this Participant Information Sheet and signed Informed Consent Form will be given to
you to keep.
Part 1
1
Why is this study being done?
This study is the first in human study of the drug VAL201, which means it has never been given
to humans before.
The main purpose of this study is to find the maximum dose that can be given to patients with
either prostate cancer or other hormonally driven tumours. VAL201 is a manmade peptide (or
small protein) which is intended to treat hormone-sensitive tumours by blocking the tumour
cells normal hormone driven activity without affecting the patient’s sexual hormone function.
VAL201 is intended to interfere with the cells of the tumour, inhibiting them from their normal
reproduction and the creation of new tumour cells. It is natural for cells to produce new cells
whilst the older cells die. It is hoped that by slowing and stopping the creation of new cells, the
size of the tumour will reduce.


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 2 of 17
Participants will be given weekly doses of VAL201 over a 21-day cycle. The study aims to assess
patients over 6 cycles of treatment and any side effects will be closely monitored. The aim of the
study is to gradually increase the dose over groups of patients. Each dose will need to be shown
to be safe and well tolerated before the study moves onto the next dose level.
In addition to finding the maximum safe dose, the study will also investigate how VAL201 is
absorbed, distributed, and removed from the body by evaluating the drug levels in the blood.
There will also be assessments into how well VAL201 is able to prevent or slow the growth of
the cancer tumour, and other biological effects on the body and the tumour.
2
Why have I been invited?
You have been identified by your cancer consultant/oncologist as being suitable for this study.
Eligible patients have locally advanced or metastatic prostate cancer or other advanced solid
tumours.  A locally advanced cancer is one that has started to spread to nearby tissues and a
metastatic cancer has spread to other parts of the body.
Up to 42 male and female patients aged 16 years or over, will be invited to take part in this study.
3
Do I have to take part?
Your participation is entirely voluntary, which means it is up to you to decide whether to join the
study.  Once you are happy that you understand this Participant Information Sheet and if you
agree to take part, you will be asked to sign an Informed Consent Form.  You are free to change
your mind and withdraw at any time, without giving a reason.  This will not affect the standard of
care you receive.
4
What will happen to me if I take part?
You will be invited for a screening visit to review the study and to assess your eligibility for the
study. If you decide to take part in the study a study doctor or nurse (as appropriate) will talk
you through the study and you will be asked to sign a study consent form. The screening
assessments can take place up to 28 days before you receive your first dose of drug.
Once confirmed as eligible you will progress onto the study to receive doses of VAL201 once a
week on a 21-day cycle. It is hoped that you will receive up to 6 cycles of treatment if your
tumour is responding well to treatment. Your physician will inject VAL201 subcutaneously (or
just under your skin) in up to 4 sites (depending on the dose) most likely your upper arm, thigh
or stomach region. The intended drug doses on the study are expected to range from 0.5mg/kg
(based on your weight) to a maximum of 16.0mg/kg.
The dosing will continue if your tumour is responding to treatment for 6 cycles (though
treatment may carry on past 6 cycles if you are doing well and your doctor feels you may
benefit). If your physician feels that you are not benefiting, your treatment will be stopped and
you will be invited to return 30 days after the last dose of drug for a final assessment.
From the screening visit to the final assessment, the study could take up to 6 months. If the study
drug results show that the growth of your tumour has slowed or halted and your study doctor
feels you may benefit, you may be allowed to continue taking the study drug after this study
completes.
At the time of publishing this document, the study drug has been safely administered to 12
patients. The most common side effects recorded are an injection site reaction and fatigue.  You
will be closely monitored by the study team and a number of assessments performed at each
study visit. Please see the following table for a list of clinic visits and assessments to be
conducted (Table 1 for screening to Cycle 6 and Table 2 for clinic visits for Cycle 7 onwards):


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 3 of 17
Table 1 – Study Schedule and Assessments – Screening to Cycle 6
CYCLE 1
CYCLE 2
CYCLE 3
CYCLE 4
CYCLE 5
CYCLE 6
FINAL
CYCLE
VISIT
FINAL
VISIT
Day
Day
Day
Day
Day
Day
Day
C6D22
-28
to 0
1
2
8
15
1
8
15
1
2
8
15
1
2
8
15
1
8
15
1
2
8
15
Informed consent
X
Patient information
and demographics
(ethnic origin/race,
sex etc.)
X
Review of medical
history
(prior diseases and
illnesses)
X
Assessment 
of
disease and how it
affects 
patients
daily life (ECOG)
X
X
X
X
X
X
X
X
Physical
examination
(including 
height
and weight)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Vital signs (heart
rate/pulse, 
blood
pressure,
temperature 
and
breathing rate)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 4 of 17
Electrocardiogram
– review of heart
function
X
X
X
X
X
X
X
X
X
Blood samples
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Urine Collection &
Pregnancy 
test
(females only)
X
X
X
X
X
X
X
Tumour
assessment
(CT scan or MRI
scan,
and 
bone
scan every three
cycles)
X
X
(X)
(X)
Tumour
assessment
(PSA blood test)
X
X
X
X
X
X
X
(X)
(X)
Tumour 
tissue
sample/biopsy
(optional)
(X)
(X)
Review 
of 
side
effects 
and
ongoing 
subject
health
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Review of non-
study medications
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Dosing of study
drug (VAL201)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 5 of 17
Footnotes

Additional assessments may be conducted as clinically indicated.

(X) denotes an assessment that is optional. The study team will be asking you separately whether you
consent to this specific assessment

Blood samples will be taken to check your health during screening and on Day 1 of each cycle and at
the final study visit;

Blood samples to investigate study drug levels may be taken at :

Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 6 Day 1: Pre-dose (0h) then 5, 10, 15, 30, 60, 90 min,
2, 3, 4, 5, 6, 8 h post-administration

Blood samples for how study drug is affecting you and your tumour (up to 7 samples) will be taken in
the study, at screening and Day 15 of every cycle of treatment up to Cycle 6.
As the study progresses, the Sponsor may decide to alter when the study dosing and
assessments are to be performed compared to the above summary. In this case you will be
provided with a separate table listing the visits and the assessments to be conducted.
Table 2 – Study Schedule and Assessments –Cycle 7 onwards
Cycle 7 onwards
Final
Study
Visit
Day
1
8
15
Assessment of disease and how it affects patients daily life (ECOG)
X
X
Physical examination
X
X
Vital signs (heart rate/pulse, blood pressure, temperature and breathing rate)
X
X
Electrocardiogram – review of heart function
X
X
Blood samples
X
X
Pregnancy test (females only)
X
Tumour assessment every 4 cycles
(CT scan or MRI scan, and bone scan – disease specific)
X
(X)
Review of side effects and ongoing subject health
X
X
X
X
Review of non-study medications
X
X
X
X
VAL201 administration
X
X
X
Footnotes

Additional assessments may be conducted as clinically indicated.
Review of Medical History and Non-study Medications
At the start of the study you will be asked to provide information about your medical history and
a list of medications including any current or past drugs, any herbal therapies, any self-
medications such as multivitamins and minerals and any over the counter medications you may
be taking for pain, cold or allergies. At all subsequent visits, if your condition and/or medications
change during the course of the study, you will need to inform the study staff of these changes.
Disease assessment and effect on daily life
The Eastern Cooperative Oncology Group (ECOG) performance scale is used by doctors and
researchers to assess how a patient's disease is progressing. It will be used to assess how your
disease affects your daily living abilities throughout the study.
Physical Examination


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 6 of 17
This will include an examination of your general appearance, head and neck, eyes and ears, nose
and throat, chest, lungs, heart, abdomen, extremities and joints, lymph nodes, skin, and tests on
your nervous systems (e.g., eye movement, knee jerk). Height and weight will also be measured
at screening with weight checks taken over the study.
Vital Sign Assessment
Vital signs measurement (including your temperature, breathing rate, blood pressure, and heart
rate/pulse) will be obtained.
Electrocardiogram (ECG)
An electrocardiogram will be used to measure the electrical activity of your heart.
Blood Samples
Blood samples will be taken over the course of the study and will include various tests to check
your health and to check for the study drug levels in your blood. Additional blood samples will be
taken to assess how VAL201 is affecting both you and the tumour. These samples will be
destroyed after completion of the study.
All tests performed for safety measures such as standard haematology and blood chemistry will
be analysed at a local laboratory. The samples will be handled and destroyed after analysis
according to the local laboratory standard procedures.
Blood samples for all other analyses will be stored and sent outside of the hospital to specialized
secure laboratories for analysis. The samples will be sent coded, thus your identity can only be
traced back to you through the study site personnel who will keep a code list.
Urine Collection
Urine samples will be taken for various tests to check your ongoing health. These samples will be
analysed locally at your hospital and will be handled and destroyed after analysis according to
the local laboratory standard procedures.
Pregnancy testing
For female participants only, there will be regular pregnancy testing. The analysis will be
conducted on blood or urine collected as part of your safety assessments.
Tumour Assessment – disease assessments
The status of your tumour will be checked by MRI scans or CT scans; if you are a prostate cancer
patient you may also have radionuclide bone scans to assess the tumour.
1) Whole body radionuclide bone scan (Prostate cancer patients only)- A bone scan involves
injecting a radioactive material (radiotracer) into a blood vein. The substance travels
through your blood to the bones and organs. As it wears off, it gives off a little bit of
radiation. This radiation is detected by a camera that slowly scans your body. The camera
takes pictures of how much radiotracer collects in the bones and will be used to show any
bone lesions or metastatic tumours in your bones.
2)
CT scan (computerised tomography) - A CT scan uses X-rays and a computer to create
detailed images of the inside of the body.  You'll be exposed to radiation in the form of X-rays
from your chest down to the tops of your legs (pelvis) to assess your tumour.
3)
MRI (Magnetic resonance imaging) – An MRI scan uses a large magnet and radio waves
to look at organs and structures inside your body to assess your tumour.
4)
Prostate cancer patients only – Prostate-specific Antigen blood analysis will be
conducted for patients with prostate cancer only to assess their disease status. This analysis


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 7 of 17
forms part of the blood sampling that is conducted locally at your hospital throughout the study.
Optional Tissue Sampling – Biopsy collections
New tumour tissue samples - the provision of tumour tissue samples or biopsy samples is
completely optional to you. If you decide not to consent to the procedures to obtain such
samples, your involvement in the study or future medical care will not be affected. The tissue
samples will be taken for the assessment of biological activity of the study drug in the tumour
tissue. If you provide consent to have tissue samples collected, after you have received an
anaesthetic (the area will be numbed or the lower part of your body will be numbed with an
injection at your spine), your doctor will look at your tumour and snip small pieces (biopsies) of
it for storage and testing later in the laboratory. Imaging may be used to help locate the tumour
when collecting the tissue sample.  Two samples will be collected, one prior to the start of study
drug e.g. at screening and one after treatment has commenced in Cycle 3 Day 15. During the
study, the tissue samples will be stored in a secure laboratory, with a sub-sample prepared for
storage and future evaluation of study drug. After completion of the study analysis of these
samples, if there is any remaining tissue it will be returned to your local hospital for your Doctor
to use to support your future medical treatment.
If you do agree to provide a biopsy sample an additional 10 ml blood sample will be taken to
enable a genetic comparison of your body’s normal DNA to the tumour cell DNA. The results of
the tests for this optional part are for research purposes only investigating mutations in tumour
cell DNA.  The results will not be of individual significance to you and they will not be used for
your medical care.  Therefore, results will not be provided to you or your study doctor.
Access to previously collected tumour tissues samples– if you have previously had a biopsy of
your tumour we may ask you to consent to have access to part of this sample tissue for study
testing. The study Sponsor will only request access to this historical tissue sample from your
doctor following specific written approval from yourself to do so. After completion of the study
analysis of this sample, if there is any remaining tissue it will be returned to your local hospital
for your Doctor to use to support your future medical treatment.
If you do agree to provide a biopsy sample from tumour tissue that you have previously provided
prior to this study, an additional 10 ml blood sample will be taken to enable a genetic comparison
of your body’s normal DNA to the tumour cell DNA. The results of the tests for this optional part
are for research purposes only investigating mutations in tumour cell DNA.  The results will not
be of individual significance to you and they will not be used for your medical care.  Therefore,
results will not be provided to you or your study doctor.
Review of Side Effects and Ongoing Subject Health
Throughout the study you will be asked how you feel and will be encouraged to report to your
study doctor if you feel unwell at any time. You will be given a card with contact details of your
study doctor who you can contact to report any effects you are feeling throughout the study up
until your final study assessment visit.
Study Visits and Dosing Days
The diagram below summarises the expected number of visits and the study design.  The starting
dose of VAL201 was 0.5 mg/kg (0.5 mg per every kg you weigh) in the first cohort of patients,
and as the study progresses to the 6th cohort of patients, the dose will not exceed 16.0 mg/kg.
You will receive doses of VAL201 once a week on a 21-day cycle.
For Cycles 1, 3, 4 and 6 you will attend for visits on Days 1, 2, 8 and 15 and during Cycles 2 and 5
you will attend for visits on Days 1, 8, 15.
If your doctor feels you are doing well and you are benefiting from treatment, you may continue


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 8 of 17
to receive Cycles of treatment on Days 1, 8 and 15 after Cycle 6.  A Follow-up visit will be
completed 30 days after your last dose of treatment.
Diagram 1 Summary of visits and dosing days Cohorts 5&6
5
Expenses and payments
The study sponsor ValiRx is providing the study drug VAL201 free of charge and will cover all
other study related costs or procedures not considered part of standard care for someone with
your illness. Reasonable travel costs (by public transport or car, including parking) arising from
attending study visits will be reimbursed in exchange for a receipt. You will not be paid for
participating in this study.
Your study doctor and study clinic/hospital are being paid by the study sponsor to conduct this
research.
Any data or specimens (for example, blood, urine, tissue samples) collected during this study and
stored after study completion, may be used in research or in the development of future products.
The sponsor does not intend to provide you with ownership or financial benefits that may result
from this research or future commercial products.
6
What will I have to do?
You will be asked to attend the research unit for the screening visit and every assessment and
dosing day as detailed in the study schedule (Table 1 or a separate schedule as provided to you by
your research team) up until a final study assessment. However you may withdraw at any time or
the study doctor may decide it is in your best interests to be removed from the study.
It is important that, at all times during the study, you tell the study staff if you have taken any other
medications than those given to you for the purpose of this study or agreed with your study doctor.
This includes any over-the-counter medications, vitamins, herbal supplements or dietary
supplements. If you have to see another doctor or are admitted into the hospital, please let them
know that you are participating in this study and show them the patient card you will receive from
your study doctor. Please notify the study staff as quickly as possible of these types of events.
7
What are the alternatives for diagnosis or treatment?
Discuss with your doctor what other specific treatment options you have and your doctor will
discuss the alternative treatments.
8
What are the possible disadvantages and risks of taking part?


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 9 of 17
Before participating in this study, you should consider if this will affect any personal insurance e.g.
life insurance/assurance you have and seek advice if necessary.
Surgery: Tissue sampling / Tumour Biopsy
The surgical risks are similar to biopsies that you have previously had. These include a risk of
bleeding and infection. In addition, there are risks associated with the anaesthesia used which may
include feeling sick/nausea, vomiting, or infection at the site of the needle injection.
Administration of study drug
The study drug VAL201, will be injected under the skin (subcutaneously) into most likely your
upper arm, leg (thigh) or stomach (approximately an inch away from your belly button).  You may
experience some discomfort in the injection area. Please report all discomfort experienced to your
study doctor.
Other Risks:
Blood Sampling
Drawing blood results in local discomfort and may also cause bruising. No more than 631.5 ml
(just over a pint) of blood will be drawn over the 6–month period from screening to the Final
Study visit. Placement of a cannula (small plastic tube placed directly into the blood vein) is a
routine procedure that involves momentary discomfort at the time of insertion. Minor bruising
may occur. In rare cases, phlebitis (irritation of the vein), extravasation (leaking of fluid outside
the vein), and infection can also occur which resolves with or without antibiotic treatment.
Electrocardiogram
Some people have a skin reaction to the sticky electrode patches that attach to the chest for the
electrocardiogram. This skin irritation usually disappears when the patches are removed. Some
males may have some chest hair shaved to ensure adequate contact between the electrodes and
the skin.
Whole body radionuclide bone scan
The scan involves one injection but, apart from that, it is painless. To have the scan, you first have
a radioactive substance called a radionuclide injected into your bloodstream.
Before you have the injection, the nurse or radiographer will ask you about allergies or asthma as
some people can be allergic to it. The injection may make you feel hot and flushed for a minute or
two. The doctor will ask you to pass urine just before you return (or when you return) to get rid of
any radionuclide in your bladder. Otherwise this could interfere with the scan.  When you are
ready for the scan, you will lie down on an X-ray couch and will need to keep still. Your body goes
through the scanner. This makes some people feel claustrophobic, so let your doctor or nurse
know if you feel nervous as they can help to reassure you. The scan takes about an hour.
The
radiation dose of each bone scan is equivalent to about 14 months of natural background
radiation.  The risk of all the bone scans causing a cancer is about 1 in 1100. The body gets rid of
the radionuclide in the urine. This takes up to 24 hours. If you need to take any precautions in the
meantime, the doctor or nurses will tell you beforehand.
CT scan or MRI
A CT scan uses X-rays and a computer to create detailed images of the inside of the body.  You'll be
exposed to radiation in the form of X-rays for a full body scan. The radiation dose of each CT is
equivalent to about 8 years of natural background radiation.  The risk of all the potential CT scans
including the possible CT biopsy causing a cancer is about 1 in 143.
These risks (from the bone scans and the CT scans) should be considered in the context of 1 in 4


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 10 of 17
naturally occurring risk and are the risks to the average population and not someone with your
clinical condition.  Therefore it is reasonable to say that the risk from the radiation from this study
can be considered small.
An MRI is a type of scan that uses strong magnetic fields and radio waves to produce detailed
images of the inside of the body. An MRI scan is a painless and safe procedure. You may find it
uncomfortable if you have claustrophobia and are nor suitable for people who have certain types
of implants.  Please talk to your doctor if you have any questions or concerns about these tests.
Allergic Reactions
Rare or unknown side effects could possibly occur, including life-threatening reactions. As with
any drug, it is possible that you could experience an allergic reaction, such as itching, skin rash,
facial swelling, and an acute or sudden drop in blood pressure. The latter may lead to shock with
loss of consciousness and/or possible seizures, including the possibility of death. If any of the
above symptoms of an allergic reaction occurs, seek medical attention immediately.
Please remember that as with any drug, there is a risk that a rare or previously unknown side
effect will occur.
9
What are the side effects of any treatment when taking part?
Patients that have received VAL201 in clinical study to date, have experienced the following side
effects considered related to the VAL201 study drug:

Injection site reaction (rash/redness/pain/tenderness/itching/bruising)

Fatigue

Raised blood pressure (hypertension)
If you experience any side effects that you are concerned about you should contact your study
doctor immediately.
<add study doctor contact details here>
Harm to the unborn child:
You must avoid becoming pregnant or fathering a child while participating in this study. If you are
a woman that can bear children (that is, not surgically sterile or has not gone through menopause),
there may be a possibility that the study drug may harm an unborn child or nursing infant. For this
reason, if you are pregnant, plan to become pregnant, or are breast- feeding, you CANNOT take
part in this study. By signing the consent form, you confirm to the best of your knowledge that you
are not pregnant now, you are not currently breast-feeding and you do not intend to become
pregnant or start breast feeding during the study. If at any time during this study you think you
might be pregnant, or later learn that you were pregnant during the study or wish to start breast
feeding, you must contact the study doctor immediately for further instructions regarding your
participation in this study and follow-up. If you become pregnant at any time during the study you
will be immediately withdrawn from the study.
If you are a woman that can bear children, you must have a negative blood pregnancy test at
screening before you can enter the study. In addition, if you are a woman that can bear children, or
a man whose female partner can bear children, you and your partner must BOTH be on a form of
contraception during the treatment period and for at least 1month after the last dose of the study
drug.


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 11 of 17
If you are a male patient, you should use an effective method of contraception method upon
enrolment, during the course of the study, and for 1month following the last study drug dosing. In
the case of the woman who can bear children (whether study subject or partner of the study
subject), you/she must already be using an effective method of contraception (e.g. barrier
methods with spermicides, oral or parenteral contraceptives and/or intrauterine device
(a device which is placed within the uterus)).
In the case of the man (whether study participant or partner of the study subject), an effective
form of contraception must be used.
10
What are the possible benefits of taking part?
It is possible that you may benefit from the care given and that your tumour may respond to the
study treatment. VAL201 has not been tested in humans previously which means that there is no
evidence that your treatment will be successful. You should not enrol in this study with any
expectation that you will personally benefit, but your participation may help to provide
information that will be useful for future patients needing treatment for tumours like yours.
Research provides wider benefits to society / others with a similar condition and some indirect
benefits might be foreseeable for participants themselves.
11
What happens when the research study stops?
If the study drug results show that the growth of your tumour has slowed or halted and your study
doctor feels you may benefit, you may be allowed to continue taking the study drug for more than
6 cycles as part of this protocol.  You will be expected to continue to attend study visits as required
by your doctor so that your progress can be monitored.
12
What if there is a problem?
Any complaint about the way you have been dealt with during the study or any possible harm you
might suffer will be addressed.  The detailed information on this is given in Part 2.
13
Will my taking part in the study be kept confidential?
Yes, we will follow ethical and legal practice and all information about you will be handled in
confidence.  The details are included in Part 2.
This completes part 1.


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 12 of 17
Part 2.
1
What if new information becomes available?
Sometimes during the course of the study new information becomes available concerning the
investigational drug. If this happens, your study doctor will tell you about it and discuss with you
whether you want to continue in the study. Also on receiving new information your study doctor
might consider it to be in your best interests to withdraw you from the study. He/she will explain
the reasons why it is best that you do not continue on study and will arrange for your ongoing
medical care.
2
What happens if I don’t want to carry on with the study?
Your decision to take part in this study is entirely voluntary, and you can change your mind at a
later stage.
Any decision to withdraw (or to decline this invitation to take part) in this study will not affect the
care you receive from any relevant service (e.g. for patients, from the NHS).
Information and data collected up until the time of your withdrawal of consent may still be used.
Any stored blood or tissue samples already collected will remain the property of the study
Sponsor until they are destroyed (blood) or returned to your local hospital for your Doctor to use
to support your future medical treatment (tissue).
3
What if there is a problem?
If you have a concern about any aspect of this study, you should ask to speak to the study team
who will do their best to answer your questions, <Dr Name> at Tel. No. <tel number>. If you
remain unhappy and wish to complain formally, you can do this <add complaint procedure here>.
The Sponsor does not expect you to suffer any health problems by taking part in this study.
However, the Sponsor will compensate any patient who suffers injury, which is attributable to this
study in accordance with the Clinical Trial Compensation Guidelines published by the Association
of the British Pharmaceutical Industry (ABPI), a copy of which is available on request.
If you experience a research injury, emergency medical treatment will be provided.  A research
injury is any physical injury or illness caused by administration of the Sponsor study medicine or
any study procedure that would not have occurred but for your inclusion in the study.
NHS trusts will compensate for medical negligence on their part.
4
Will my taking part in the study be kept confidential?
ValiRx Plc, is the sponsor for this study based in the United Kingdom. We will be using information
from you and your medical records in order to undertake this study and will act as the data
controller for this study. This means that we are responsible for looking after your information
and using it properly. ValiRx Plc, will keep identifiable information about you for a minimum of 15
years after the study has finished.
Your rights to access, change or move your information are limited, as we need to manage your
information in specific ways in order for the research to be reliable and accurate. If you withdraw
from the study, we will keep the information about you that we have already obtained. To
safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information at https://www.valirx.com/about-
us/privacy-and-gdpr/ or contact George.morris@valirx.com.
[NHS site] will collect information from you and your medical records for this research study in


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 13 of 17
accordance with our instructions.
[NHS site] will keep your name, NHS number and contact details confidential and will not pass this
information to ValiRxPlc. [NHS site] will use this information as needed, to contact you about the
research study, and make sure that relevant information about the study is recorded for your care,
and to oversee the quality of the study. Certain individuals from ValiRx Plc and regulatory
organisations may look at your medical and research records to check the accuracy of the research
study. ValiRx Plc will only receive information without any identifying information. The people
who analyse the information will not be able to identify you and will not be able to find out your
name, NHS number or contact details.
[NHS site] will keep identifiable information about you from this study for at least 15 years after
the study has finished.
When you agree to take part in a research study, the information about your health and care may
be provided to researchers running other research studies in this organisation and in other
organisations. These organisations may be universities, NHS organisations or companies involved
in health and care research in this country or abroad. Your information will only be used by
organisations and researchers to conduct research in accordance with the UK Policy Framework
for Health and Social Care Research.
Your information could be used for research in any aspect of health or care, and could be
combined with information about you from other sources held by researchers, the NHS or
government.
Where this information could identify you, the information will be held securely with strict
arrangements about who can access the information. The information will only be used for the
purpose of health and care research, or to contact you about future opportunities to participate in
research. It will not be used to make decisions about future services available to you, such as
insurance.
Where there is a risk that you can be identified your data will only be used in research that has
been independently reviewed by an ethics committee.
Throughout this study your doctors, nurses, and other study personnel will record information
about you in forms provided by us (known as “case report forms”). This personal information will
include information about your health and your demographic details (such as your date of birth,
your sex, and your ethnic origin/race).
All records and all other information about you entered into the case report forms will be
identified by a unique study participant number, not your full name.
The Sponsor may use the information collected by us:

By storing and analysing it electronically to find out what this study is telling us;

by sharing it with regulatory authorities that approve new medicines, or with groups that
check that research is done properly;

by publishing the results of the study (this will not include any information that directly
identifies you);

By sharing it as part of research with other companies or universities for the purpose of
further understanding or developing this drug. If the information is sent to another
country, ValiRx will apply the same level of protection to your information, to the extent
permitted by local law;

By using it to plan new studies or other types of research or other medical purposes
related to the development of the drug.


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 14 of 17
By consenting to this study you understand that all data derived from this study or from the
specimens or samples obtained from you are the properties of the study Sponsor. In the event you
withdraw your consent to participate in the study, you may be asked if you will allow the
continued analysis of your samples and specimens, collected up to the time you withdrew your
consent and the data to be used in analyses. Your permission will be recorded in writing. However,
as provided under applicable data protection law you have the right of access to data relating to
yourself and if needed, correct such data. You have certain rights, which may allow you to have
access to data held about you, and to object or prevent certain processing of your information if it
will cause you damage or distress. You understand that you may obtain access to such data
through your study doctor.
Monitors, auditors, ethics committees and the regulatory authorities will be granted direct access
to your original medical records for verification of clinical trial procedures and/or data, without
violating your confidentiality, to the extent permitted by the applicable laws and regulations.
By signing the written informed consent form you authorise such access. For further details on
your rights and how you can enforce them, you should contact the Information Commissioner
(Wycliffe House, Water Lane, Wilmslow, and Cheshire, SK9 5AF).
5
Involvement of the General Practitioner/Family doctor (GP)
With your consent your family doctor (General Practitioner) will be told that you have decided to
take part in this study.
6
What will happen to the samples I give?
Your samples will be stored and used for the tests described in this Participant Information Sheet.
Any excess blood samples will be destroyed by the Sponsor when the analysis has been completed.
Any remaining tissue samples will be returned to your local hospital for your Doctor to use to
support your future medical treatment.
Blood samples will be taken over the course of the study and will include various tests to check
your health and to check for the study drug levels in your blood. Additional blood samples will be
taken to assess how VAL201 is affecting both you and the tumour. Specifically there will be
assessment of biomarkers on both blood and tissue samples. A biomarker is a biological molecule
found in blood, other body fluids or tissues that is a sign of a normal or abnormal process, or of a
condition or disease. A biomarker may be used to see how well the body responds to a treatment
for a disease or condition.
You will be requested to provide a specific consent for the optional testing on archived and/or
fresh tumour tissue where a sample is available.
7
What will happen to the results of the research study?
The study results will be published on a publically accessible database e.g. clinincialtrials.gov and
may also be published in scientific journals, however in all cases, personal information identifying
you as a participant will not be released.
8
Who is organising and funding the research?
The study is sponsored by ValiRx plc. UK, a pharmaceutical company.  This means that ValiRx plc
is paying the research team for the costs of the study.
9
Who has reviewed the study?


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 15 of 17
The study protocol and this information sheet has been submitted to the UK Regulatory Authority
(MHRA) and a registered Research Ethics Committee and these committees have approved this
study. This study will be conducted under Good Clinical Practice guidelines (an international
ethical and scientific quality standard for clinical trials involving human participants).
Further information and contact details
If you have any questions about this study, please contact your study doctor or other study
personnel.
Contact details [add the details of Principal Investigator; if the PI is not the point of contact for the
patient, modify accordingly]:
Study doctor:
tel.
<Add study nurse’s name and telephone number>
For any concerns about your rights as a participant or any complaints please contact:
<Add hospital/trust complaints department/patient services>
For emergencies only please contact:
<Add 24hr emergency telephone number>
Before you sign the informed consent form, you should ask questions about anything that you do
not understand.  The study staff will answer any questions before, during and after the study.
Thank you for taking the time to read this information sheet.


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 16 of 17
Centre Number:
Study Number:  VAL201-001
Patient Identification Number for this trial:
CONSENT FORM
Title of Project: A Phase I/II, Dose Escalation Study to Assess the Safety and Tolerability of
VAL201 in Patients with Locally Advanced or Metastatic Prostate Cancer and Other
Advanced Solid Tumours
Name of Researcher: [NAME OF INVESTIGATOR]
Please initial
all boxes
1.
I confirm that I have read and understand the information sheet dated [DATE]
(version [VERSION NUMBER]) for the above study.  I have had the opportunity to
consider the information, ask questions and have had these answered satisfactorily.
2.
I have been informed that there has been a change in the planned study dosing and
assessment schedule and have been provided with the new schedule [VERSION
NUMBER]) for  reference.
Not applicable
3.
I understand that my participation is voluntary and that I am free to withdraw at any
time without giving any reason, without my medical care or legal rights being affected.
4.
I confirm to the best of my knowledge that I am not pregnant now, am not currently
breast-feeding and do not intend to become pregnant or start breast feeding during the
study.
5.
I understand that relevant sections of my medical notes and data collected during the
study, may be looked at by individuals from ValiRx, from ValiRx authorised persons,
from regulatory authorities or from the NHS Trust, where it is relevant to my taking
part in this research.  I give permission for these individuals to have access to my
records.
6.
I agree to take part in the above study. I agree that samples taken from me and my
personal data, in anonymised form may be transferred and used as described in the
PIS for the study.
7.
I agree to my GP being informed of my participation in the study.
Not applicable for males


ValiRx Plc
Protocol Number: VAL201-001
IRAS ID: 152483
PIS and ICF version: 6.0 dated 05 August 2019
Page 17 of 17
Optional testing for tumour biopsy analysis - by initialing either of the following two boxes
below I am specifically providing consent for the optional tumour analysis listed. If I decide not to
consent to this testing, I understand that my involvement in the study or future medical care will not
be affected.
8.
I agree to allow ValiRx assess to any previously collected tumor material that may be
available to my study doctor. I understand that part of this sample may be transferred
to a secure laboratory for testing located outside of my hospital facility and may be
used for future testing of the study drug. I understand that there will also be an
additional 10 ml blood sample taken to enable a genetic comparison of my body’s
normal DNA to tumour cell DNA.
9.
I agree to undergo two biopsy procedures on my tumor (one prior to and one after
dosing) to provide tissue samples for analysis as part of this research project.  I
understand that part of this sample may be transferred to a secure laboratory for
testing located outside of my hospital facility and may be used for future testing of the
study drug. I understand that there will also be an additional 10 ml blood sample
taken to enable a genetic comparison of my body’s normal DNA to tumour cell DNA.
Name of Participant
Date
Time
Signature
Name of Person
Date
Time
Signature
taking consent
(Optional)
(Optional)

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