Trial purpose
Diagnostic
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This study aims to assess how safe and effective a radioactive tracer (called [68Ga]Ga-A9-6217) is at helping visualise potential tumours.
You may be eligible for this study if you have advanced or metastatic breast cancer, prostate cancer, non-small cell lung cancer, small cell lung cancer, or colorectal (bowel) cancer.
All participants 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 session that lasts for approximately 6 hours to complete at least 2 full body PET scans, which will include an injection of the tracer [68Ga]Ga-A9-6217 and collection of blood and urine samples at various timepoints. Participants may be asked to complete 2 additional scans and will then be followed for up to 2 days, including general monitoring.
It is hoped that this study will help determine if [68Ga]Ga-A9-6217 is a safe and effective tracer that can be used in the diagnosis and monitoring of tumours in people with cancer.
Conditions
This trial is treating people with advanced or metastatic breast, bowel, prostate, non-small cell or small cell lung cancers
Eligibility
Inclusion
1. Histologically or cytologically confirmed advanced or metastatic breast cancer, prostate cancer, NSCLC, SCLC, or CRC
2. Willing to provide an archival tumor sample, if available, for immunohistochemistry
3. Age equal to or greater than 18 years old
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 Tumors (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 the first 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 2 weeks following exposure to the investigational product
10. Laboratory values at screening must be as follows:
a. Hematology:
i. Absolute neutrophil count equal to 1,000 cells/mm3
ii. Platelet count equal to 75,000 cells/mm3
iii. Hemoglobin 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 equal to 40 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation
c. Coagulation:
i. International normalized ratio must be < 1.5 × upper limit of normal (ULN)
d. Liver:
i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) equal to 2.5 × ULN or equal to 5 × ULN in the presence of liver metastases
Exclusion
1. 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-A9-6217.
4. Cardiovascular exclusions:
a. A medical condition that the Investigator assesses 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Alpha-9 Theranostics
Scientific Title
A Phase 1 Study Investigating the Safety, Biodistribution, and Dosimetry of [68Ga]Ga-A9-6217 in Participants with Select Advanced or Metastatic Solid Tumors
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