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
Known hypersensitivity to the investigational medicinal products (DOTA-STR-17126) or any of the excipients.
Participants with Class 3 or 4 New York Heart Association (NYHA) Congestive Heart Failure.
Average QTc (using the Fridericia correction calculation) > 470 msec for females and QTcF >450 msec for males on screening ECG or history of congenital long QT syndrome.
Clinically significant bleeding within two weeks prior to trial entry (i.e., gastrointestinal bleeding, intracranial bleeding).