XCancer

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

Description:

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.

Sponsor:

Unknown Organization

Phase:

Early Phase 1

Contacts:

Nat Lenzo, MD (PRINCIPAL_INVESTIGATOR)

Amma P Owusu, RN BSc MN (CONTACT)

research.iit@icon.team

+61498120411

Duncan Colyer, RN BN PGDip (CONTACT)

research.iit@icon.team

Government Study Link:

NCT07608848 - Click here to see study on

ClinicalTrials.gov

DOTA-STR-17126

Isotope(s):
Target(s):
  • GRPR
Ligand Class: Peptides
Chelator: DOTA
Inclusion
  • Ability to understand and willingness to provide informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • Must have the following histologically or cytologically confirmed diagnosis of advanced or metastatic i. breast cancer ii. prostate cancer
  • Adults ≥ 18 years of age
  • Inclusion criteria refer to the enrolment of participants for the PET/CT and SPECT/CT imaging with the radioligands; PET imaging tracer \[68Ga\]Ga-DOTA-STR-17126 and with the SPECT imaging tracer \[177Lu\]Lu-DOTA-STR-17126. Participants must meet all of the following inclusion criteria to be eligible for enrolment.
Exclusion
  • Clinically significant bleeding within two weeks prior to trial entry (i.e., gastrointestinal bleeding, intracranial bleeding).
  • Participants with Class 3 or 4 New York Heart Association (NYHA) Congestive Heart Failure.
  • Participants must not be enrolled into the trial if one or more of the following criteria are met. Participants must NOT meet any of the following Exclusion criteria to be eligible for enrolment:
  • 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.
  • Known hypersensitivity to the investigational medicinal products (DOTA-STR-17126) or any of the excipients.