None listed
Conditions
Brief summary
This study aims to assess the safety of the study imaging tracer in Participants with Advanced Solid Tumours. The study imaging tracer is a radioactive tracer that is used to assist with visualising tumors during a specific type of PET scan. Who is it for? You may be eligible for this study if you are aged 18 years or above with advanced or metastatic triple negative breast cancer, squamous non-small cell lung cancer, oesophageal squamous cell cancer or head and neck squamous cell cancer. Study details All participants who choose to enrol in this study will be asked to attend a Screening Visit which may need to take place over more than 1 day. Participants deemed eligible following their screening visits will be required to attend a single study visit that lasts for up to 8 hours. During this visit participants will be asked to complete at least 3 full body PET scans, which will include an injection of the study tracer and collection of blood samples at various timepoints. Participants may be asked to complete 1 additional scans and will then be followed up for 6 days, including general monitoring. It is hoped that this study will help determine if the study imaging agent is a safe and effective tracer that can be used in the imaging of tumours in individuals with cancer.
Interventions
This is an open-label, non-controlled, interventional Phase 1 clinical study of a gallium-68 (68Ga) labelled PET imaging tracer in patients with solid tumours who have received treatment with at least one prior chemotherapy, or targeted therapy, or immuno-oncology agent.
This study will include only participants who have one of the following tumour types: TNBC, sqNSCLC, OSCC, or HNSCC.
The study will initially assess imaging and pharmacokinetics (PK) of [68Ga]Ga-AB101 in up to 10 participants w
This is an open-label, non-controlled, interventional Phase 1 clinical study of a gallium-68 (68Ga) labelled PET imaging tracer in patients with solid tumours who have received treatment with at least one prior chemotherapy, or targeted therapy, or immuno-oncology agent. This study will include only participants who have one of the following tumour types: TNBC, sqNSCLC, OSCC, or HNSCC. The study will initially assess imaging and pharmacokinetics (PK) of [68Ga]Ga-AB101 in up to 10 participants with any of the carcinoma indications). Depending on the results, the study will continue to assess imaging and PK of [68Ga]Ga-AB101 in up to 5 participants in each of the carcinoma indications [68Ga]Ga-AB101 will be administered once, as a single intravenous injection, by a qualified nuclear medicine physician or nuclear medicine technologist. This will be followed by 3 -4 PET/CT scans up to 6 hours post-dose. The administered activity is calculated based on body weight, at a dose of 2 MBq/Kg. At least 3 scans will be done. A 4th scan may be done depending on how clearly the image shows the actual body tissue compared to region to the background. The first scan will take about 30mins and the other scans will take approximately 30 min.
Sponsors
ARTBIO Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or over and capable of giving signed informed consent 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2. 3.Locally advanced or metastatic carcinoma with histological confirmation of one of the following indications: triple negative breast cancer (TNBC), squamous non-small cell lung cancer (sqNSCLC), oesophageal squamous cell carcinoma (OSCC), head and neck squamous cell carcinoma (HNSCC). 4. Availability of an archival tumour sample for immunohistochemical (IHC) analysis. 5. Previous treatment requirements: at least one prior chemotherapy, or targeted therapy or immuno-oncology agent. 6. Presence of at least one [fluorine-18 (18F)]fluorodeoxyglucose (FDG) PET-avid, non-necrotic lesion measuring at least 1 cm with no prior radiation therapy within 28 days before study imaging agent administration. 7. Adequate bone marrow, renal, and hepatic function. 8. Participants must agree to use highly effective contraception during the study and for 30 days after the last dose of study imaging agent. Male participants must also agree to refrain from donating sperm during and fathering a child until 90 days after the last dose of study imaging agent.
Exclusion criteria
1. Inability or unwillingness to undergo PET/CT imaging. 2. Bladder outflow obstruction or unmanageable urinary incontinence. 3. A known additional malignancy that has required active treatment within the past 2 years before start of the study, except for adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ that has undergone curative therapy. 4. Active clinically serious infection or serious non-healing wound, ulcer, or bone fracture. 5. Major surgery or significant trauma within 4 weeks before start of study. 6. Impaired cardiac function or clinically significant cardiac disease. 7. Known allergies, hypersensitivity, or intolerance to PET/CT tracers or compounds similar to the study imaging agent (including excipients). 8. Administration of a radiopharmaceutical within five half-lives of the radionuclide used prior to injection of the study imaging agent. 9. Prior radiotherapy completed less than two weeks before the start of study. 10. Concurrent participation in the active treatment part of another clinical study with IMP(s).
Outcome results
None listed