None listed
Conditions
Brief summary
Study purpose: The aim of this study is to determine if a new investigational radiopharmaceutical product used to perform PET scans can distinguish participants who are not responding to immune check point inhibitor (ICI) treatment from those that are responding. Who is it for? Participants with resectable, locally advanced or metastatic solid malignancy intended for immune checkpoint inhibitor therapy either alone or in combination with chemotherapy and/or radiotherapy. Study details: Participants will complete two CDI-DX001 PET imaging tests to assess tumour uptake of CDI-DX001. The first of these tests will be done within 14 days before ICI therapy is started and the second will be done 3-7 days after administration of the second dose of therapy (approximately 3-5 weeks later). Vital signs (heart rate, blood pressure, and temperature), a physical exam, and an ECG will be conducted on the day of each scan. Participants will otherwise undertake standard of care treatment as per their treating oncologist. It is hoped that the findings of this study may contribute to earlier identification of non-response to immune checkpoint inhibitor (ICI) therapy, reduce delays in initiating subsequent treatment strategies, and inform the development of novel therapeutic approaches.
Interventions
CDI-DX001 is an investigational radiopharmaceutical for imaging of multiple forms of cell death using PET/CT in near real time.
CDI-DX001 is administered as an intravenous (IV) bolus with the volume administered to study participants to be determined by the level of activity (MBq/mL) and the weight of the participant, with a target dose of 1.8 - 2.2MBq/kg (± 10%) (minimum 111MBq, maximum 259 MBq). CDI-DX001 will be administered by a qualified Nuclear Medicine Technician.
Study participants wi
CDI-DX001 is an investigational radiopharmaceutical for imaging of multiple forms of cell death using PET/CT in near real time. CDI-DX001 is administered as an intravenous (IV) bolus with the volume administered to study participants to be determined by the level of activity (MBq/mL) and the weight of the participant, with a target dose of 1.8 - 2.2MBq/kg (± 10%) (minimum 111MBq, maximum 259 MBq). CDI-DX001 will be administered by a qualified Nuclear Medicine Technician. Study participants will undergo an approximately 30 minute PET/CT at 60 minutes ± 6 minutes post CDI-DX001 administration. Each participant will undergo two (2) CDI-DX001 PET scans, one within 14 days prior to commencing treatment, and the second within 3-7 days (inclusive) after administration of cycle 2 of ICI of treatment. These two imaging visits will occur over an average period of approximately 8 weeks, and a maximum period of 15 weeks depending on treatment cycle length. Participants will undertake standard of care treatment as per their treating oncologist. Participant outcomes will be collected from standard of care assessments for up to 12 months or until final closure of the study. This includes histological assessment of resected tissue (where available), standard imaging modalities (CT/MRI/FDG-PET) and/or biological markers where relevant.
Sponsors
Centenary Institute of Cancer Medicine and Cell Biology
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent will be obtained before any study specific procedure. Participants must be able to understand and willing to sign the written informed consent. 2. Male or female participants greater than or equal to 18 years of age. 3. Histologically or cytologically confirmed solid malignancy intended for immune checkpoint inhibitor treatment either alone or in combination with chemotherapy and/or radiotherapy. 4. At least one measurable lesion greater than or equal to 2 cm in maximum transaxial dimension. Where external beam radiotherapy is also being administered at least one measurable lesion must be outside of the irradiated volume in the opinion of the treating radiation oncologist. 5. Adequate renal function (eGFR >30 ml/min/1.73m2) 6. Female participants of non-childbearing potential (i.e post-menopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], or has undergone hysterectomy or bilateral oophorectomy). OR Female participants of childbearing potential with a negative serum pregnancy test within 7 days prior to the first CDI-DX001 PET scan, and must agree to use a highly effective and approved contraceptive method until 24 hours after the last CDI-DX001 PET scan. OR Male participants who are capable of fathering a child must agree to use a highly effective and approved contraceptive method prior to the first CDI-DX001 PET scan until 24 hours after the last CDI-DX001 PET scan.
Exclusion criteria
1. Cancer treatment within the previous 4 weeks. External beam radiotherapy is permitted within the previous 4 weeks provided there is at least one measurable lesion outside of the irradiated volume in the opinion of the treating radiation oncologist. 2. Major surgery within 4 weeks to the site / all sites of measurable disease. Biopsy is permitted. Where there is at least one site of measurable disease outside of the operative field, surgery within 4 weeks is permitted. 3. For solid malignancy of the urinary tract the disease must not be isolated to the kidney, ureter or bladder. 4. Active uncontrolled infection. 5. Congestive heart failure or prior NYHA class III-IV cardiac disease. 6. Uncontrolled hypertension (systolic BP > 180mmHg or diastolic BP >100mmHg). 7. Pregnancy. 8. Breast feeding. 9. Allergy to CDI-DX001 or any of its components.
Outcome results
None listed