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

Sponsor
Integrated Haematology and Oncology Network
Study ID
NCT07608848
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Active Cancer
  • Cancer
  • GRPR-Targeted Molecular Imaging
  • Metastatic Breast Cancer
  • Metastatic Prostate Cancer
  • Radiopharmaceutical
  • Theranostic
  • Theranostic Radiopharmaceuticals

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [177Lu]Lu-DOTA-STR-17126 — DRUG
    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.
  • [68Ga]Ga-DOTA-STR-17126 — DRUG
    Participants will receive a single intravenous bolus dose of 150+/-50MBq (25 - 50 micrograms) of \[68Ga\]Ga-DOTA-STR-17126 precursor.

Study Details

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.

Key Dates

First listed
May 27, 2026
Start date
May 28, 2026
Status verified
Jun 2026
Primary completion
May 30, 2028
Completion
May 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: [68Ga]Ga-DOTA-STR-17126 and Low Dose [177Lu]Lu-DOTA-STR-17126
    The intervention involves administration of two radiopharmaceuticals under investigation: Part 1: \[68Ga\] Ga-DOTA-STR-17126 is used as a PET imaging tracer to identify tumour lesions with high expression of GRPR. Participants will receive a single intravenous bolus dose of 150+/-50MBq (50 micrograms) of DOTA-STR-17126 precursor. Part 2: Participants who have GRPR positive lesions identified by \[68Ga\] Ga-DOTA-STR-17126 PET imaging will receive a low Dose \[177Lu\] Lu-DOTA-STR-17126. Eligible participant(s) will receive 1.0+/-0.5GBq (50 microgram peptide) dose of \[177Lu\] Lu-DOTA-STR-17126, administered as a slow intravenous infusion. SPECT/CT scans will be performed to assess the biodistribution, dosimetry, and extrapolation of potential therapeutic dose potential of the radiopharmaceutical.

Primary Outcome Measure

Number of participants with adverse events (AEs), serious adverse events (SAEs), with abnormal laboratory parameters (hematology, blood chemistry, and urinalysis), abnormal Physical examinations findings [ Time Frame: Day 43 ]

Central Contacts

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