First-in-human Diagnostic Imaging Profile of the Theranostic Pair [68Ga]Ga-DOTA-STR-17126 and Low… (NCT07608848) | Clinical Trial Compass
RecruitingEarly Phase 1
First-in-human Diagnostic Imaging Profile of the Theranostic Pair [68Ga]Ga-DOTA-STR-17126 and Low Dose [177Lu] Lu-DOTA-STR-17126 in Patients With Advanced or Metastatic Cancer
Australia20 participantsStarted 2026-05-28
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events (AEs), serious adverse events (SAEs), with abnormal laboratory parameters (hematology, blood chemistry, and urinalysis), abnormal Physical examinations findings
Timeframe: Day 43
Trial details
NCT IDNCT07608848
SponsorIntegrated Haematology and Oncology Network
. Participants must have adequate organ and bone marrow function, defined as follows:
. Able to remain still for up to 60 minutes per scan
Exclusion criteria
. 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).
. Pregnant or lactating women. i. For female participants of childbearing potential or male participants with female partner of childbearing potential, who are not willing to practice highly effective contraception during the trial and for at least 6 months after \[177Lu\] Lu-DOTA-STR-17126 administration ii. Sexually active males must use a condom during intercourse while taking the drug and for 4 months after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Female partners of childbearing potential should use highly effective contraceptive methods during and up to 6 months after stopping treatment.
. Have any medical condition that impairs complete bladder emptying. Participants with permanent urinary indwelling catheter (IDC) or nephrostomy may be allowed to enrol on a case-by-case basis in discussion with Principal Investigator, if it is determined not to put the patient at an increased risk of adverse drug effects and/or interfere with the integrity of study outcome.
. Major surgery, defined as any surgical procedure that involves general anaesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 30 days before study day 1 or anticipated surgery within the subsequent 43 days (6 weeks).
. Has an additional active malignancy requiring therapy within the past 2 years.