RecruitingEarly Phase IEN originalBreast cancerProstate cancerMetastatic / advanced

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Zgoda na udział w badaniu i rozumienie jego zasad.
  • Osoby pełnoletnie (powyżej 18 lat).
  • Potwierdzony rak piersi lub prostaty w zaawansowanym stadium lub z przerzutami.
  • Ogólny stan zdrowia pozwalający na udział w badaniu (sprawność w skali ECOG 0-1).
  • Potwierdzony postęp choroby w ciągu ostatnich 30 dni.
  • Pacjenci, którzy wyczerpali standardowe leczenie.
  • Wystarczające parametry funkcji narządów i szpiku kostnego.
  • Możliwość spokojnego leżenia przez maksymalnie 60 minut podczas każdego badania obrazowego.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
June 10, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

Icon Cancer Centre Hollywood

Perth, Australia

Trial contact

Amma P Owusu, RN BSc MN

Duncan Colyer, RN BN PGDip

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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