Gallium Imaging Pilot Study in Metastatic Melanoma
- Conditions
- Metastatic MelanomaLocally Advanced MelanomaCancer - Malignant melanoma
- Registration Number
- ACTRN12624000085572
- Lead Sponsor
- Alpha-9 Theranostics Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
1. Has histologically or cytologically confirmed locally advanced or metastatic melanoma.
2. 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.
3. Age greater than or equal to 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 or 1.
6. Expected life expectancy of >12 weeks per the Investigator.
7. 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
8. 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.
9. At least 4 weeks from prior major surgery.
10. 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.
11. 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
1.5 × 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 .
1. 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.
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
peptide therapeutics, 68Ga-A9T-3202.
4. 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.
5. 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.
6. 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.)
7. 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.
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 in discussion with study Sponsor.
9. Participants with a history of leptomeningeal disease may not participate even if clinically
stable.
10. Pregnant or lactating.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method