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Study identifier: NCT07608848 Synced from ClinicalTrials.gov · July 29, 2026
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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

Condition: Metastatic Breast Cancer · Metastatic Prostate Cancer · GRPR-Targeted Molecular Imaging  ·  Sponsor: Integrated Haematology and Oncology Network

PhaseEARLY_Phase 1
Planned participants20
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Amma P Owusu, RN BSc MN  ·  +61498120411  ·  research.iit@icon.team

Duncan Colyer, RN BN PGDip  ·  research.iit@icon.team

Always discuss trial participation with your own doctor first.

Locations (1)

Icon Cancer Centre HollywoodPerth, Western Australia, AustraliaRecruiting

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Source record: clinicaltrials.gov/study/NCT07608848