Gallium Imaging Pilot Study in Metastatic Melanoma
A Multicentre, Phase 1 Study Investigating the Safety, Tumor Uptake, Biodistribution, and Dosimetry of 68Ga-A9T-3202 in Participants with Locally Advanced or Metastatic Melanoma
Alpha-9 Theranostics Australia Pty Ltd
30 participants
Apr 24, 2024
Interventional
Conditions
Summary
This study aims to assess the safety and tolerability of a new tumour imaging agent in patients with locally advanced or metastatic melanoma. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older and have been diagnosed with locally advanced or metastatic melanoma. All potential participants will be reviewed by the study investigators to ensure that they meet additional health criteria before enrolment. Study details All participants who choose to consent in this study will undergo a screening visit to assess their eligibility. An 18F-FDG-PET and CT scans will be required for assessing participant eligibility, however if these scans were performed as part of standard of care prior to the date of consent but are within 28 days of the Day 1, they may not need to be repeated. Each participant's circumstances will be assessed by a study investigator and participants will be advised if scans need to be repeated. If eligible, participants will receive a single dose of 68Ga-A9T-3202 via intravenous injection, and then undergo 4 whole body PET-CT scans at set timepoints on the day of administration. Participants will then complete an End of Observation visit (one day post IP administration) to check participant safety and tolerability of 68Ga-A9T-3202. It is hoped this research will demonstrate that 68Ga-A9T-3202 is safe and well tolerated by patients with metastatic melanoma, and provide more accurate staging and treatment response evaluation when compared to the current standard of care PET/CT imaging.
Eligibility
Inclusion Criteria37
- Has histologically or cytologically confirmed locally advanced or metastatic melanoma.
- 18F-FDG-PET proven disease in the recent 3 months. 18F-FDG-PET scans performed prior to date of consent, as part of a participant’s routine clinical assessments, but within the 28 day screening window can be used to assess eligibility and are not required to be repeated unless specified by the Study Investigator.
- Age greater than or equal to 18 years old.
- Mentally competent and able to understand and sign the Informed Consent Form.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Expected life expectancy of >12 weeks per the Investigator.
- Participants must have at least one lesion with the following characteristics (measured by diagnostic CT imaging). CT scans performed prior to date of consent, as part of a participant’s routine clinical assessments, but within the 28 day screening window can be used to assess eligibility and are not required to be repeated unless specified by the Study Investigator.:
- visceral organ metastases greater than 1 cm
- nodal metastases greater than 1 cm short axis diameter
- bone lesions with a soft-tissue component of at least 1 cm in short axis
- 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.
- At least 4 weeks from prior major surgery.
- 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 1 month following exposure to the investigational product.
- Laboratory values at screening must be as follows:
- a. Hematology:
- i. Absolute neutrophil count greater than or equal to 1,500 cells/mm3.
- ii. Platelet count greater than or equal to 100,000 cells/mm3.
- iii. Hemoglobin greater than or equal to 10 g/dL (transfusion is acceptable to meet this
- criterion but must be longer than 14 days before administration).
- b. Renal:
- i. Serum creatinine < 1.5 × upper limit of normal (ULN) or creatinine clearance greater
- than or equal to 60 mL/min based on the Cockcroft-Gault glomerular filtration rate
- estimation.
- c. Coagulation:
- i. International normalized ratio must be < 1.5 × ULN.
- ii. Prothrombin time or activated partial thromboplastin time greater than or equal to
- 5 × ULN unless undergoing anticoagulation therapy.
- d. Cardiac QTc<0.44sec based on 12-lead electrocardiogram within 30 days of
- enrolment.
- e. Liver:
- i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than or
- equal to 2.5 × ULN or greater than or equal to 5 x ULN in the presence of liver
- metastases .
Exclusion Criteria37
- Have 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 such as participants with severe claustrophobia who are
- unresponsive to oral anxiolytics, participants with low back pain who cannot lie
- comfortably on an imaging table, participants who are hyperactive or hyperkinetic such
- that they cannot tolerate lying still for multiple time-point imaging procedures, etc.
- 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
- peptide therapeutics, 68Ga-A9T-3202.
- Cardiovascular exclusions:
- a. Has a medical condition that the Investigator assesses could interfere with the
- administration of the diagnostic agent or assessment of toxicity or response to the
- diagnostic agent.
- b. Has clinically significant cardiac disease not controlled on medical therapy (e.g.,
- congestive cardiac failure, arrhythmia, coronary heart disease).
- c. Has a medical history of myocardial infarction or unstable angina within 6 months
- before Day 1.
- Other exclusions:
- a. Was previously enrolled in this study.
- b. Is actively enrolled in another clinical study unless it is an observational
- (noninterventional) clinical study or the follow-up component of an interventional
- study.
- c. Use of another systemic anticancer therapy within 3 weeks prior to Day 1 or 5 half-lives,
- whichever is shorter, unless agreed to following discussion with the Medical Monitor.
- Prior External Beam Radiation Therapy (EBRT)
- Volume > 25% of the bone marrow.
- Within 4 weeks of 68Ga-A9T-3202 dosing. (Exceptions may be approved on a case-by-
- case basis in discussion with study Sponsor.)
- Recent medical concerns exclusions:
- Has evidence of active infection requiring IV antibiotics within 7 days prior to Day 1.
- Has active uncontrolled bleeding or a bleeding diathesis within 7 days prior to Day 1.
- Has serious or non-healing wound, fistula, skin ulcer, or non-healing bone fracture
- within 7 days prior to Day 1.
- History of organ transplant.
- 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 in discussion with study Sponsor.
- Participants with a history of leptomeningeal disease may not participate even if clinically
- stable.
- Pregnant or lactating.
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Interventions
This study involves the use of an investigational imaging product, 68Ga-A9T-3202. 68Ga-A9T-3202 is an investigational imaging agent being developed for patients with MC1R positive metastatic melanoma. A single dose of 68Ga-A9T-3202 will be administered via intravenous injection by a Nuclear Medicine Physician prior to whole body PET-CT scans being performed at 4 timepoints post dose (15mins, 30mins, 60mins and 150mins post dose for conventional scanners; dynamic scan at 0-30mins post dose, static scans at 60mins, and 120min with an optional scan at 240mins post dose for Long Axial Field-of-View scanners). The radioactivity of the injected dose will be determined according to body weight, with a target administration activity of 2MBq/kg ±10%. The maximum administered activity will not exceed 300MBq.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12624000085572