An Open-label, First-in-human, Exploratory Imaging Study of the DOTA-STR-17126 Theranostic Pair [68Ga]Ga-DOTA-STR-17126 and Low-dose [177Lu]Lu-DOTA-STR-17126 in Patients With Advanced or Metastatic Cancer
This is an open-label, first-in-human, exploratory Phase 0 study evaluating the safety and diagnostic imaging performance of the DOTA-STR-17126 theranostic pair in patients with advanced or metastatic breast or prostate cancer. The study investigates \[68Ga\]Ga-DOTA-STR-17126 for PET imaging and, in patients with positive GRPR uptake, a low dose of \[177Lu\]Lu-DOTA-STR-17126 for SPECT imaging and dosimetry. The primary objective is to assess safety and tolerability. Secondary objectives include evaluation of imaging quality, biodistribution, pharmacokinetics, and radiation dosimetry. Exploratory objectives assess correlations between GRPR expression in tumour tissue and imaging uptake. The study is conducted at a single centre in Australia, with 12 evaluable participants (up to 20 enrolled), and supports the development of a GRPR-targeted theranostic approach for personalised cancer management.
• Ability to understand and willingness to provide informed consent
• Adults ≥ 18 years of age
• Must have the following histologically or cytologically confirmed diagnosis of advanced or metastatic i. breast cancer ii. prostate cancer
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Participant must have clinical or radiological documented tumour progression as established by the Investigator within 30 days of signing consent for the study
• Participants who have exhausted standard-of-care systemic therapies in their metastatic setting. At least one detectable by conventional imaging tumour lesion with any diameter of ≥ 1 cm in size
• Participants must have adequate organ and bone marrow function, defined as follows:
• i. Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 ii. Platelet count ≥ 100,000/mm3 iii. Haemoglobin ≥ 9.0 g/dL iv. AST, ALT, alkaline phosphatase ≤ 3 times upper limit of normal (ULN) if there is no evidence of liver metastases or ≤5 ULN in the presence of liver metastases v. Total bilirubin ≤ 2 times upper limit of normal (ULN) vi. Creatinine ≤ 2 times ULN and creatinine clearance (CrCL) ≥ 60mL/min using the Cockcroft Gault equation (Appendix 2)
• Able to remain still for up to 60 minutes per scan
• Any other condition which, in the opinion of the Investigator, would preclude participation in this study Optional: Participants that have available archival tissue (at least 15 consecutive, unstained, formalin-fixed, paraffin embedded (FFPE) slides or 1 FFPE block), or a fresh tumour biopsy sample that opt to provide samples will be used for GRPR analysis (histology staining or RNA measurements). Participants without any archival tissue or fresh biopsy sample, or who refuse to provide archival tissue are still eligible for the study.