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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Robert Ladner
+44 (0) 2890972674
rladner@cv6t.com


Prof Richard Wilson
+44 (0)141 3307523, (0)141 3017043
Richard.h.wilson@glasgow.ac.uk


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Be Part of Research - Trial Details - A first in human study to investigate the safety and tolerability of CV6-168 in combination with anti-cancer treatments in patients with advanced cancer.
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A first in human study to investigate the safety and tolerability of CV6-168 in combination with anti-cancer treatments in patients with advanced cancer.

Recruiting

Open to: All Genders

Age: Mixed

Glasgow Newcastle upon Tyne Belfast Surrey

Medical Conditions

Advanced malignancies

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


CV6-168 is a new experimental medicine to be given to humans for the first time. The study goal is to determine whether giving CV6-168 in combination with other anti-cancer treatments is a safe, tolerable, and effective treatment for patients with cancer. Different doses of CV6-168 and different anti-cancer treatments will be tested to see if there is an optimal dose and combination.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

18 Apr 2024 30 Sep 2025

This is a modular design study which consists of Module 1 and an optional Module 2. Each Module consists of Part A, B (Optional for Module 2), C (Optional) and D (Optional). Module 1 with Part A and Part B will be investigated first for the optimal combination doses of CV6-168 with other anti-cancer treatments.
The expected duration of the trial for each patient is up to 34 weeks for Part A and up to 31 weeks for Part B. Patients in both Parts A and B will be permitted 12 treatment cycles, based on the availability of IMP. Additional treatment with CV6-168 would be based on recommendation by the Investigator in agreement with the Sponsor. Part C will be investigated for dose optimisation and Part D will be investigated for dose expansion.

There will be substantial protocol amendments to provide additional modules.
Further Modules may explore:
1. Combinations with other standard-of-care anti-cancer treatments.
2. The effect of food on the bioavailability of CV6-168.
3. A switch of formulation of CV6-168.

The end of the study is defined as the last visit of the last patient participating in the study.


Patients aged at least 18 years old with a diagnosis of an advanced cancer

You can take part if:



You may not be able to take part if:


Module 1 Exclusion Criteria: Exclusion Criteria for Part A (Dose Escalation) & Part B (Dose Expansion)To be eligible for inclusion into this study, each patient must violate none of the following exclusion criteria within 28 days before C1D1:1. Patients who received treatment for the malignancy within 28 days before the first dose of IMP. 2. Patients with an active bacterial or viral infection (including Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2], Herpes Zoster, Varicella Zoster or chickenpox), including a major systemic infection requiring antibiotics or antivirals 1 week or less prior to the first dose of study drug.3. Patients with known active hepatitis B or C (mandatory testing not required).4. Patients with known Human Immunodeficiency Virus (HIV) infection (mandatory testing not required). 5. Patients with any other condition, including mental illness or substance abuse or abnormal laboratory results, deemed by the Investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results. This includes (but is not limited to) the following:5.1. Congestive heart failure (New York Heart Association Class III or Class IV).5.2. Clinically significant coronary heart disease or myocardial infarction within 6 months of the first dose of study medication or high risk of uncontrolled arrhythmia. 5.3. Unstable or poorly controlled angina pectoris. 5.4. Complete left bundle branch, fascicular block or other clinically significant abnormal ECG finding. 5.5. QTc interval >470 milliseconds using the Fridericia formula.5.6. History of or current risk factor for torsade de pointes (e.g., heart failure, hypokalaemia, or a family history of long QT syndrome). 5.7. History of severe skin reactions.5.8. History of severe ocular disorders.5.9. Interstitial pneumonitis or pulmonary fibrosis.5.10. Diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalisation in the preceding 6 months; or any other intercurrent medical condition that contra-indicates treatment with CV6-168 or places the patient at undue risk for treatment-related complications.6. Female patients who are pregnant or breastfeeding.7. Patients who have had any active bleeding in the last ≤ 4 weeks or have an otherwise known bleeding diathesis.8. History of hypersensitivity or current contra-indications or severe toxicity to 5-FU (irrespective of DPYD polymorphism status), FUdR or capecitabine.9. Evidence of central nervous system (CNS) or leptomeningeal metastases.10. Palliative radiotherapy during participation in the study is permitted but should not be concurrent with study treatment and recovery should be allowed to prevent overlapping toxicity. It should not include a target lesion.11. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, curatively treated in situ cancer of the cervix, surgically excised or potentially curatively treated ductal carcinoma in situ of the breast or potentially curatively treated in situ melanoma, superficial bladder cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for at least 3 years.12. Thromboembolic event in the 6 months before inclusion (e.g., transitory ischemic stroke, stroke, subarachnoid haemorrhage) except deep vein thrombosis treated with therapeutic anticoagulants which have been discontinued and asymptomatic pulmonary emboli.13. Acute intestinal obstruction, sub-acute obstruction in the preceding 4 weeks, or history of uncontrolled inflammatory intestinal disease.14. Received a live vaccination within four weeks of the first planned dose of study medication.15. Known DPYD mutations associated with potential increased toxicity from fluoropyrimidines.16. Required concomitant use of drugs known to prolong QT/QTc interval.17. Patients who are on any dose of warfarin or are on full dose anticoagulation with other agents (including low molecular weight heparin, antithrombin agents, anti-platelet agents and more than 325 mg daily aspirin) within 7 days prior to first dose of study drug are excluded. Patients on prophylactic doses of low-molecular-weight heparin or aspirin at doses lower than 325 mg daily are allowed on study.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Beatson West of Scotland Cancer Centre
    1053 Great Western Road
    Glasgow
    G12 0YN
  • Freeman Hospital
    Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • Belfast City Hospital
    51 Lisburn Rd
    Belfast
    BT9 7AB
  • The Royal Marsden Hospital (surrey)
    Downs Road, Sutton
    Surrey
    SM2 5PT

Blood Sampling:
Blood collection either by direct venepuncture or indwelling cannula may cause mild pain & bruising at the collection site. The placement of an indwelling catheter is proposed to minimise these effects for rapid PK sampling. Very rarely, a vein blockage or a small nerve injury can occur, resulting in numbness & pain which will resolve with time.
Women of childbearing potential, any patient who is pregnant, breastfeeding or intending to become pregnant will not be eligible for participation. Women of childbearing potential, patients must agree to use two highly effective forms of contraception with their partner using a condom (if applicable) during the study & for at least 6 months following the last dose of study medication.
Male patients with partners of childbearing potential, must not father a child during this study or for a safety period of 6-months following the last dose of study medication. Patients must agree to use two highly effective forms of contraception with their partner using a condom (if applicable) during the study & for at least 6 months following the last dose of study medication. Male patients who have been sterilised or engage in non-vaginal intercourse should use a condom to prevent exposure of semen to any partner (male or female) until 6 months following the last dose of study medication. Patients must not donate sperm until 6 months following the last dose of study medication.
A small number of people have a skin reaction to the stick electrode patches that attach to the chest for the electrocardiogram. Skin irritation usually disappears when patches are removed. Some men may need to have some chest hair shaved to ensure adequate contact between the electrodes & skin.
During an echocardiogram, the patient may feel sick and dizzy, and experience some chest pain. There’s a small chance of the procedure triggering an irregular heartbeat or heart attack. Patients will be monitored carefully during the procedure, which will be stopped if there are any signs of problems.
A cardiac MRI is an optional assessment which can be used instead of an echocardiogram. It may involve an injection of contrast medium, which can cause some side effects, such as headache, feeling sick (nausea) or dizziness. These effects are most common, but only happen in less than 1 in every 200 patients & generally do not last long.
For tumour imaging, Computed Tomography (CT) is the preferred imaging modality, but Magnetic Resonance Imaging (MRI) or CT/MRI is also accepted. Contrast CT and/or MRI chest, abdomen and pelvis (CAP) should be performed, but non-contrast is accepted if patients cannot tolerate contrast. Brain CT/MRI will be performed only if clinically indicated. Generally, the amount of radiation exposure during each CT scan is the same as between a few months and a few years of exposure to natural radiation from the environment (including the sun). It's thought exposure to radiation during each CT scan could slightly increase the chances of developing cancer many years later, although this risk is very small (< 1 in 2,000). MRI uses radio waves and a strong magnetic field which is medically safe to provide images of internal organs and tissues. Radiation is not used for MRI, there is no risk of exposure to radiation during an MRI procedure. If the patients have any metal parts in their body, there is a risk of interference, including heating & injury. Some patients may have a ‘closed in’ feeling while inside the imaging machine(s), the contrast dye may contain iodine which some people are allergic to, it may also make the patient feel sick or faint, and may cause pain, warmth, swelling, bruising, and/or a small blood clot or infection at the injection site.
Most types of biopsies are painless once the anaesthetic starts to work, although this depends on where the sample is taken. Patients may experience nausea, vomiting & dull aches, which can be treated with painkillers. Risks of bleeding & infection can be treated on the doctor's or surgeon's advice. Mild pain is usually experienced, and the severity of pain may vary according to the site where the biopsy is being performed.
CV6-168 is a new medicine that is being given to humans for the first time & there is limited information on what the potential side effects of CV6-168 could be in humans. CV6-168 has been considered to be safe to proceed into testing in humans, there have been several preclinical studies performed & concluded no major safety concerns. CV6-168 stimulates the immune system, patients may experience a general body reaction from the infusion. This may include difficulty breathing, low blood pressure, high blood pressure, headache, skin rashes and increased temperature. The study doctor will follow patients closely during the treatment and treat them accordingly if any reaction should occur.

Prof Richard Wilson
+44 (0)141 3307523, (0)141 3017043
Richard.h.wilson@glasgow.ac.uk


Prof Robert Ladner
+44 (0) 2890972674
rladner@cv6t.com



The study is sponsored by CV6 Therapeutics (NI) Ltd and funded by CV6 Therapeutics (NI) Ltd.



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Read full details for Trial ID: ISRCTN12434145

Or CPMS 55993

Last updated 13 March 2025

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