None listed
Conditions
Brief summary
This study aims to assess the safety, tolerability, tumour uptake, biodistribution and dosimetry of a new tumour imaging agent, [68Ga]Ga-A9-5209, in patients with advanced or metastatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above with advanced or metastatic breast cancer, prostate cancer, non-small cell lung cancer, small cell lung cancer or mesothelioma. Study details All participants who choose to consent in this study will undergo a screening visit to assess their eligibility. Participants will receive a single administration of [68Ga]Ga-A9-5209 via intravenous injection on Day 1. Participants will receive up to four PET/CT scans, and four blood draws (one for each scan) on Day 1. Participants will complete a safety follow up visit/end of study visit on Day 2. Patients with advanced or metastatic breast cancer, prostate cancer, NSCLC, SCLC, or mesothelioma can participate in either Part 1 or Part 2 of this study. There will be no differences in the assessments conducted for participants in Parts 1 and 2, the analysis however will differ. Part 1 participants will be evaluated for tumour uptake, biodistribution and dosimetry of [68Ga]Ga-A9-5209. Part 2 participants will be evaluated for tumour uptake. A minimum of 4 participants per indication will be included in the study. Target indications are advanced or metastatic breast cancer, prostate cancer, non small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC), or mesothelioma. If successful, this potential new product could provide more accurate tumour staging and treatment response evaluation.
Interventions
[18F]FDG-PET and/or [68Ga]Ga PSMA 11-PET and/or [18F]DCFPyL-PET scans may be performed during screening for disease confirmation.
Following an ultra-low dose CT scan for attenuation correction, [68Ga]Ga A9 5209 will be administered to all participants as a slow intravenous push using an intravenous catheter, followed by a flush of 10 to 20 mL of normal saline for the Whole Body PET-CT. Participants will have two scans, one 60 minutes after injection and another scan 150 minutes after injection.
[18F]FDG-PET and/or [68Ga]Ga PSMA 11-PET and/or [18F]DCFPyL-PET scans may be performed during screening for disease confirmation. Following an ultra-low dose CT scan for attenuation correction, [68Ga]Ga A9 5209 will be administered to all participants as a slow intravenous push using an intravenous catheter, followed by a flush of 10 to 20 mL of normal saline for the Whole Body PET-CT. Participants will have two scans, one 60 minutes after injection and another scan 150 minutes after injection. Each scan will take 10-20 minutes. [68Ga]Ga-A9-5209 will be administered at 2 MBq/kg by a nuclear medicine technologist, a study nurse, or by an investigator. Part 1: 10 participants evaluating tumour uptake, biodistribution and dosimetry Part 2: Up to 30 additional participants: a minimum of 4 participants per indication should be included in the study. Target indications are advanced or metastatic breast cancer, prostate cancer, non small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC), or mesothelioma. There will be no differences in the assessments conducted for participants in Parts 1 and 2, the analysis however will differ. Part 1 participants will be enrolled first, once that cohort is complete then Part 2 participants will be enrolled.
Sponsors
Alpha-9 Theranostics
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. Histologically or cytologically confirmed advanced or metastatic breast cancer, prostate cancer, NSCLC, SCLC, or mesothelioma 2. Willing to provide an archival tumour sample, if available, for B1R immunohistochemistry 3. Age 18 years old or older 4. Mentally competent and able to understand and sign the Informed Consent Form 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 6. Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST 1.1): Participants with bone-only disease evaluable by PSMA-PET and/or FDG-PET may be included in the study after discussion with the Medical Monitor. 7. Participants with brain metastases are eligible, provided they meet the following criteria: a. Radiotherapy or surgery for brain metastases was completed at least 4 weeks prior to administration of investigational product b. Symptoms are stable and steroid/antiepileptic doses remain unchanged for a minimum of 4 weeks 8. At least 4 weeks from prior major surgery 9. Willing to use contraceptive measures: women of childbearing potential and men must agree to use effective methods of contraception (hormonal or barrier methods or abstinence) before study entry, during study participation, and for 6 months following exposure to the investigational product. 10. Laboratory values at screening must be as follows: a. Hematology: i. Absolute neutrophil count greater than 1,000 cells/mm3 ii. Platelet count greater than 75,000 cells/mm3 iii. Haemoglobin greater than or equal to 8 g/dL (4.96 mmol/L): Transfusion is acceptable to meet this criterion but not within 7 days before administration of investigational product. b. Renal: i. Creatinine clearance greater than or equal to 40 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation c. Coagulation: i. International normalized ratio (INR) must be less than 1.5 × upper limit of normal (ULN) d. Liver: i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 × ULN or less than or equal to 5 × ULN in the presence of liver metastases
Exclusion criteria
Any medical condition that would, in the Investigator’s judgment, prevent the participant’s full participation in the clinical study due to safety concerns or compliance with clinical study procedures 2. Residual toxicity > Grade 1 from prior anticancer therapy (except alopecia and/or fatigue) 3. History of uncontrolled allergic reactions and/or known or expected hypersensitivity to a peptide-based imaging or therapeutic agent or any excipient present in [68Ga]Ga-A9-5209 4. Cardiovascular exclusions: a. A medical condition that, in the opinion of the Investigator, could interfere with the administration of diagnostic agent or assessment of toxicity b. Clinically significant cardiac disease not controlled on medical therapy (e.g., congestive cardiac failure, arrhythmia, coronary heart disease) c. History of myocardial infarction or unstable angina within 6 months before Day 1 5. Other exclusions: a. Previous enrollment in this study b. Concomitant treatment with a radiopharmaceutical agent 6. Prior External Beam Radiation Therapy (EBRT) comprising a volume > 25% of the bone marrow 7. Recent medical concerns exclusions: a. Uncontrolled bleeding or a bleeding diathesis within 7 days prior to Day 1 b. Serious or non-healing wound, fistula, skin ulcer, or non-healing bone fracture within 7 days prior to Day 1 c. History of organ transplant 8. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer: Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis after discussion with the Medical Monitor. 9. Pregnant or lactating
Outcome results
None listed