PET/CT Imaging of GRPR Expression in Various Tumors

NCT07828678 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2027-5057
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This open-label imaging study will evaluate \[⁶⁸Ga\]-LY4257529 PET/CT, a gastrin-releasing peptide receptor (GRPR)-targeted radiopharmaceutical, in patients with cancers known or suspected to express GRPR. Up to 60 participants will be enrolled in two cohorts: 30 patients with breast cancer and 30 patients with other selected malignancies, including prostate, ovarian, pancreatic, small-cell lung, head and neck squamous cell carcinoma, and other tumors with documented GRPR expression.

Conditions

Malignancies Multiple

Keywords

GRPR; PET/CT

Outcome Measures

Primary Outcomes (1)

• Per-Patient GRPR PET/CT Detection Rate

  Proportion of participants with at least one GRPR-positive lesion on \[⁶⁸Ga\]-LY4257529 PET/CT. Detection rate will be calculated as the number of participants with at least one GRPR-positive lesion divided by the total number of participants in the relevant cancer cohort.

  After the PET/CT imaging is completed

Study Arms (1)

[⁶⁸Ga]-GRPR PET/CT

EXPERIMENTAL

Participants with breast cancer or other selected GRPR-expressing malignancies will receive a single intravenous administration of approximately 170 MBq ±20% of \[⁶⁸Ga\]-LY4257529, followed by PET/CT imaging approximately 50-70 minutes after injection. All participants undergo the same imaging intervention.

Diagnostic Test: GRPR PET/CT

Interventions

GRPR PET/CT DIAGNOSTIC_TEST

\[⁶⁸Ga\]-LY4257529 is an investigational gastrin-releasing peptide receptor (GRPR)-targeted PET radiopharmaceutical. Participants will receive approximately 170 MBq ±20% (4.6 mCi ±20%) intravenously. PET/CT imaging will begin approximately 50-70 minutes after administration to evaluate GRPR-targeted tumor uptake and distribution.

[⁶⁸Ga]-GRPR PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older Able to understand and provide written informed consent
• Diagnosis of a breast cancer or other tumor known or suspected to express GRPR, including:
• ER-positive/HER2-negative breast cancer Invasive lobular breast cancer Head and neck squamous cell carcinoma Small-cell lung cancer Ovarian cancer Prostate cancer with biochemical recurrence and a negative PSMA PET/CT Metastatic pancreatic cancer after pancreatic surgery Other tumor with GRPR expression demonstrated on histopathology ECOG performance status 0-3 Under the care of a referring physician Able to tolerate PET/CT imaging, including lying supine for up to 30 minutes with arms above the head and intravenous cannulation

You may not qualify if:

• Tumor type known in the literature not to express GRPR, unless patient-specific tissue demonstrates GRPR expression Medically unstable condition, including acute cardiac or respiratory distress or hypotension Weight exceeding PET/CT table limit of 200 kg or inability to fit within the 70-cm PET/CT bore Unmanageable claustrophobia Known allergic or hypersensitivity reaction to a prior GRPR-targeting radioligand such as ⁶⁸Ga-RM2 or bombesin analogues Pregnancy Lactation For individuals of childbearing potential, inability to document a negative pregnancy test before tracer administration

Sponsors & Collaborators

• Jewish General Hospital: lead
• Eli Lilly and Company: collaborator

Central Study Contacts

Gad Abikhzer

CONTACT

514-340-8222; gad.abikhzer@mcgill.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 18, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share