Lung CancerPhase 1EvolutionNCT05510674
Safety and Dose Ranging Study for OWL-EVO1 as a Lung Cancer EVOC® Probe (Evolution)
A Phase 1 study testing OWL-EVO1 in people with Lung Cancer, run by Owlstone Ltd at 2 sites in United Kingdom.
Trial summary
The Evolution study is a phase 1a and 1b study evaluating the safety and pharmacokinetics of D5- ethyl-βGlucuronide as well as the target dose for the probe to maximize the difference between controls and subjects with lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- OWL-EVO1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 6 Jul 2021to 20 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-70 years
- Ability to provide written informed consent
- Weight not exceeding 100 kg
- Body Mass Index (BMI) between 18.5 and 30
- Meeting criteria for fitness for infusion as detailed in Section 10.3.1 - Safety Assessment Phase 1a and b Study
- Aged 55-80 years
Show all 14Show fewer
- Ability to provide informed consent
- Weight not exceeding 100kg
- BMI between 18.5 and 30.0
- Meeting criteria for fitness for infusion as detailed in Section 10.3.1 - Safety Assessment Phase 1a and b Study
- Control specific inclusion criteria - phase 1b ONLY 1. healthy as per medical records and clinical assessment at screening
- Lung cancer subject specific inclusion criteria - Phase 1b ONLY
- Tumor Node Metastasis (TNM) stage I, II, III or IV primary lung cancer.
- Multi-Disciplinary Team (MDT) diagnosis of an invasive malignant lung tumor. This evaluation should integrate data from the clinical, imaging and pathology work-up.
Who cannot join
- Phase 1a and 1b
- (Anticipated) inability to complete the breath sampling procedure due to e.g., inability to maintain adequate ventilation unaided or claustrophobia.
- Received an investigational medical product in the context of a Clinical Trial (CTIMP)during the 28 days prior to first probe administration.
- History of alcohol dependence or diagnosis of alcoholism.
- Subjects known to suffer from an unstable systemic, inflammatory, infectious, or neoplastic condition. Specifically, subjects should be excluded if:
- 4.1. Currently in the process of investigation for a potential malignancy. 4.2. Any history of cancer or indeterminate lung nodule. 4.3. Known active bacterial, fungal, or viral infection including but not limited to upper respiratory tract infection, tuberculosis, pneumonia, cystitis, pyelonephritis, active gastritis under medical treatment, prostatitis, or viral hepatitis. Patients can be recruited after being symptom free for at least 2 weeks for mild infections or 6 weeks if admitted to the hospital and/or treated with intravenous antibiotics. For the avoidance of doubt: Any skin infection without subcutaneous involvement (such as acne vulgaris) is permissible in the study.
Show all 19Show fewer
- 4.4. Clinically diagnosed presence of rheumatoid arthritis. Osteoarthritis, spondylarthritis and sports injuries are NOT exclusion criteria 28.
- 4.5. Documented history of a clinically important lung condition including asthma, Chronic Obstructive Pulmonary Disease (COPD), α1- antitrypsin deficiency, moderate to severe bronchiectasis and/or exacerbation of bronchiectasis requiring treatment, cystic fibrosis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis/mycosis, moderate to severe pulmonary fibrosis or hypersensitivity pneumonitis.
- 4.6. Known renal function impairment (eGFR 45ml/min or less). 4.7. Known liver function impairment with test results being above 1.5 times the normal upper limit.
- 4.8. Pregnant or breastfeeding women and women of child-bearing potential not using adequate contraceptive methods. Please refer to Appendix 1 for an overview of highly effective contraceptive measures that are accepted adequate contraceptive methods for this study. A woman of childbearing potential is a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient any hospitalization during the 6 weeks prior to first probe administration.
- Known glucose intolerance or Diabetes Mellitus.
- Self-reported immunocompromised patients: specifically, patients with Acquired Immune Deficiency Syndrome (AIDS), inborn or acquired severe immunodeficiency including those caused by pharmacological treatment.
- Documented history of pulmonary surgery or endobronchial interventional procedures other than biopsy, lavage, or bronchial brushings. These include surgical resection,
- Control specific exclusion criteria - phase 1b ONLY
- Under clinical investigation for lung cancer
- Current smoker
- At high risk of lung cancer: Aged 55-70 with >30 packyears smoking history, either a current smoker or quit smoking in the past 15 years as per USPSTF risk-criteria30.
- Lung cancer subject specific exclusion criteria - phase 1b ONLY
- 1. Initiation of treatment for lung cancer prior to providing final breath sample.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB20AY
Wythenshawe Hospital
Manchester, Greater Manchester, M239QZ
About this study
Official title: Safety and Dose Ranging Study for OWL-EVO1 as a Lung Cancer EVOC® Probe
The Evolution study is a phase 1a and 1b study evaluating the safety and pharmacokinetics of D5- ethyl-βGlucuronide as well as the target dose for the probe to maximize the difference between controls and subjects with lung cancer.
The phase 1a study will be designed as a single ascending dose study in healthy volunteers and will be conducted in a phase 1 trial unit with a primary objective to assess safety of the probe. A subsequent phase 1b study will be conducted at clinical sites and will aim to find the optimal dosing and breath sampling protocol to maximize the accuracy of the breath test.
Evolution Phase 1 is a multicentre study; Phase 1a will be conducted at a Phase 1 facility in Belgium and Phase 1b will be conducted in the UK.
Read the detailed description
Owlstone has recently pioneered the EVOC approach which enables active investigation of disease specific pathways by administering probe compounds to patients and measure its signal on breath. In the Evolution study, Owlstone Medical aims to evaluate one such EVOC probe strategy based on the administration of the probe OWL-EVO1.
The Evolution study consist of phase 1a, in which the safety and pharmacokinetics of OWL-EVO1 are assessed; in this part of the study up to 21 healthy volunteers will be recruited. The probe will be administered for the first time in humans in a single ascending dose design. Five different doses of the probe are planned to be administered across 5 different cohorts. This part of the study will be conducted at a Phase 1 unit in Belgium. Participating subjects will be administered a dose of the EVOC probe; up to 8 breath samples, using Owlstone's RECIVA, will be collected in a 24h wash-out.
In the subsequent Phase 1b, research will aim to identify the most optimal dose and timing of the breath test to maximise the discriminative signal between lung cancer patients (cases) and healthy controls. Up to 50 cases and 50 controls will be recruited in selected sites in the UK. The Phase 1b has been designed as an adaptive trial design. Participating subjects will be administered the probe and will provide up to 7 breath samples over a 240 minute wash-out.
This study is intended to provide proof of concept for the use of OWL-EVO1 as a probe for breath-based detection of lung cancer.
This will be an important step towards creating a breath-based screening approach for lung cancer.
- Conditions
- Lung Cancer
- Being tested
- OWL-EVO1
- Keywords
- Lung Cancer, Diagnostic Test, Diagnostic Breath Test
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OWL-EVO1Diagnostic test
Also called OWL-EVO1 Breath Biopsy Test, D5-ethyl-βD-glucuronide
EVOC probe
| Study group | Role | What they receive |
|---|---|---|
| OWL-EVO1 | Experimental | OWL-EVO1 probe will be administered to those who are fully eligible, including those diagnosed with lung cancer and healthy volunteers Receives: Diagnostic Test: OWL-EVO1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirm safety of OWL-EVO1 probe in Phase 1a
The primary endpoint for the Phase 1a study is safety of OWL-EVO1 being administered to the subjects evaluated through the number of adverse events and whether or not they are related to the administered probe.
Measured: 2 months
Determining optimal dose
To determine the optimal dose(mg/kg) of the OWL- EVO1 breath test which maximizes the discriminative signal between cases and controls
Measured: 8 months
Evaluate the safety safety of OWL-EVO1 probe in Lung cancer patients
The primary endpoint for the Phase 1b study is to evaluate safety of OWL-EVO1 in healthy subjects and Lung cancer patients.
Measured: 8 months
Determining optimal timing
To determine the optimal timing (minutes) of the OWL- EVO1 breath test which maximizes the discriminative signal between cases and controls
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start6 Jul 2021
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Owlstone Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Rintoul, Principal investigator, Royal Papworth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510674
- Sponsor's protocol ID
- OML-001
- Acronym
- Evolution
- Status last verified
- Dec 2023
- First submitted
- 4 Apr 2022
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Dose Ranging Study for OWL-EVO1 as a Lung Cancer EVOC® Probe
- ClinicalTrials.gov ID
- NCT05510674
- Acronym / sponsor ID
- Evolution / OML-001
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Diagnostic Test, Diagnostic Breath Test
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Owlstone LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Evolution study is a phase 1a and 1b study evaluating the safety and pharmacokinetics of D5- ethyl-βGlucuronide as well as the target dose for the probe to maximize the difference between controls and subjects with lung cancer.
The phase 1a study will be designed as a single ascending dose study in healthy volunteers and will be conducted in a phase 1 trial unit with a primary objective to assess safety of the probe. A subsequent phase 1b study will be conducted at clinical sites and will aim to find the optimal dosing and breath sampling protocol to maximize the accuracy of the breath test.
Evolution Phase 1 is a multicentre study; Phase 1a will be conducted at a Phase 1 facility in Belgium and Phase 1b will be conducted in the UK.
Detailed description
Owlstone has recently pioneered the EVOC approach which enables active investigation of disease specific pathways by administering probe compounds to patients and measure its signal on breath. In the Evolution study, Owlstone Medical aims to evaluate one such EVOC probe strategy based on the administration of the probe OWL-EVO1.
The Evolution study consist of phase 1a, in which the safety and pharmacokinetics of OWL-EVO1 are assessed; in this part of the study up to 21 healthy volunteers will be recruited. The probe will be administered for the first time in humans in a single ascending dose design. Five different doses of the probe are planned to be administered across 5 different cohorts. This part of the study will be conducted at a Phase 1 unit in Belgium. Participating subjects will be administered a dose of the EVOC probe; up to 8 breath samples, using Owlstone's RECIVA, will be collected in a 24h wash-out.
In the subsequent Phase 1b, research will aim to identify the most optimal dose and timing of the breath test to maximise the discriminative signal between lung cancer patients (cases) and healthy controls. Up to 50 cases and 50 controls will be recruited in selected sites in the UK. The Phase 1b has been designed as an adaptive trial design. Participating subjects will be administered the probe and will provide up to 7 breath samples over a 240 minute wash-out.
This study is intended to provide proof of concept for the use of OWL-EVO1 as a probe for breath-based detection of lung cancer.
This will be an important step towards creating a breath-based screening approach for lung cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OWL-EVO1 | Experimental | Diagnostic Test: OWL-EVO1OWL-EVO1 probe will be administered to those who are fully eligible, including those diagnosed with lung cancer and healthy volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged 18-70 years
- Ability to provide written informed consent
- Weight not exceeding 100 kg
- Body Mass Index (BMI) between 18.5 and 30
- Meeting criteria for fitness for infusion as detailed in Section 10.3.1 - Safety Assessment Phase 1a and b Study
Key exclusion criteria (19 listed)
- Phase 1a and 1b
- (Anticipated) inability to complete the breath sampling procedure due to e.g., inability to maintain adequate ventilation unaided or claustrophobia.
- Received an investigational medical product in the context of a Clinical Trial (CTIMP)during the 28 days prior to first probe administration.
- History of alcohol dependence or diagnosis of alcoholism.
- Subjects known to suffer from an unstable systemic, inflammatory, infectious, or neoplastic condition. Specifically, subjects should be excluded if:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OWL-EVO1Also: OWL-EVO1 Breath Biopsy Test, D5-ethyl-βD-glucuronideEVOC probe | Diagnostic test | OWL-EVO1 |
Primary outcome
Confirm safety of OWL-EVO1 probe in Phase 1a
Time frame: 2 months
The primary endpoint for the Phase 1a study is safety of OWL-EVO1 being administered to the subjects evaluated through the number of adverse events and whether or not they are related to the administered probe.
Determining optimal dose
Time frame: 8 months
To determine the optimal dose(mg/kg) of the OWL- EVO1 breath test which maximizes the discriminative signal between cases and controls
Evaluate the safety safety of OWL-EVO1 probe in Lung cancer patients
Time frame: 8 months
The primary endpoint for the Phase 1b study is to evaluate safety of OWL-EVO1 in healthy subjects and Lung cancer patients.
Determining optimal timing
Time frame: 8 months
To determine the optimal timing (minutes) of the OWL- EVO1 breath test which maximizes the discriminative signal between cases and controls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Rintoul principal investigator
Royal Papworth Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OWL-EVO1 in people with Lung Cancer, run by Owlstone Ltd at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm safety of OWL-EVO1 probe in Phase 1a (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.