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

ACTRN 12624000085572

Brief Summary

This study aims to assess the safety and tolerability of a new tumour imaging agent in patients with locally advancedat a late stage, far along or metastatic melanoma.

Intervention/Treatment

• Drug: 68Ga-A9T-3202

Inclusion Criteria

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:
   • Radiotherapy or surgery for brain metastases was completed at least 4 weeks prior to
     the first administration of investigational product.
   • 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:
    • Hematology:
      1. Absolute neutrophil count greater than or equal to 1,500 cells/mm3.
      2. Platelet count greater than or equal to 100,000 cells/mm3.
      3. 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).
    • Renal:
      1. 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.
    • Coagulation:
      1. International normalized ratio must be < 1.5 × ULN.
      2. Prothrombin time or activated partial thromboplastin time greater than or equal to
         1.5 × ULN unless undergoing anticoagulation therapy.
    • Cardiac QTc<0.44sec based on 12-lead electrocardiogram within 30 days of
      enrolment.
    • Liver:
      1. 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 .