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First-in-human Imaging Study of Theranostic Pair [68Ga]Ga-DOTA-STR-17126 and Low-dose [177Lu]Lu-DOTA-STR-17126 in Patients With Advanced or Metastatic Cancer

NCT07608848 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

[177Lu]Lu-DOTA-STR-17126

Participants will receive a low dose of \[177Lu\]Lu-DOTA-STR-17126, dose activity: 1.0+/-0.5 GBq (50 micrograms peptide) of \[177Lu\]Lu-DOTA-STR-17126 precursor will be administered as a slow infusion.

DRUG

[68Ga]Ga-DOTA-STR-17126

Participants will receive a single intravenous bolus dose of 150+/-50MBq (25 - 50 micrograms) of \[68Ga\]Ga-DOTA-STR-17126 precursor.

Sponsors & Collaborators

  • Integrated Haematology and Oncology Network

    lead OTHER

Principal Investigators

  • Nat Lenzo, MD · Integrated Hematology Oncology Network (Icon Group)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-03
Primary Completion
2028-05-30
Completion
2029-05-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07608848 on ClinicalTrials.gov