Safety and Dose Ranging Study for OWL-EVO1 as a Lung Cancer EVOC® Probe (Evolution)

NCT05510674 | Completed Phase 1

• 1 other identifier: OML-001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Lung Cancer

Keywords

Lung Cancer; Diagnostic Test; Diagnostic Breath Test

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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

  8 months

Study Arms (1)

OWL-EVO1

EXPERIMENTAL

OWL-EVO1 probe will be administered to those who are fully eligible, including those diagnosed with lung cancer and healthy volunteers

Diagnostic Test: OWL-EVO1

Interventions

OWL-EVO1 DIAGNOSTIC_TEST

EVOC probe

Also known as: OWL-EVO1 Breath Biopsy Test, D5-ethyl-βD-glucuronide

OWL-EVO1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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.

You may not qualify if:

• 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:
• 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.
• 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.
• 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.
• 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,
• 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.

Sponsors & Collaborators

• Owlstone Ltd: lead

Study Sites (2)

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB20AY, United Kingdom

Location

Wythenshawe Hospital

Manchester, Greater Manchester, M239QZ, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert Rintoul

  Royal Papworth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: August 22, 2022
• Study Start: July 6, 2021
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)