[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

NCT07432633 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BED-FAP-121
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of \[18F\]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).

Conditions

Colorectal Cancer; Epithelial Ovarian Cancer; Gastric Cancer; Invasive Lobular Breast Carcinoma; Pancreatic Ductal Adenocarcinoma

Keywords

Positron emission tomography; Fibroblast activation protein

Outcome Measures

Primary Outcomes (2)

• Assess radiation dosimetry of [18F]FPyQCP (Cohort A)

  Whole body effective dose of a single dose of \[18F\]FPyQCP

  Up to 360 minutes post injection

• Assess the diagnostic performance of [18F]FPyQCP in the peritoneum (Cohort B)

  Sensitivity and specificity of \[18F\]FPyQCP PET/CT compared to composite standard of truth

  Until completion of follow-up procedures, up to 42 days post injection

Secondary Outcomes (2)

• Incidence and severity of adverse events using CTCAE version 5.0 (Both Cohorts)

  From screening until safety follow-up (48 hours post injection)

• Further assess the diagnostic performance of [18F]FPyQCP (Cohort B).

  Until completion of follow-up procedures, up to 42 days post injection

Study Arms (1)

[18F]FPyQCP PET/CT

EXPERIMENTAL

Each participant will receive \[18F\]FPyQCP followed by positron emission tomography (PET)/computed tomography (CT) imaging at the PET/CT imaging visit (Visit 2)

Drug: [18F]FPyQCP

Interventions

[18F]FPyQCP DRUG

positron emission tomography (PET)/computed tomography (CT) imaging

[18F]FPyQCP PET/CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.
• Participants must be ≥ 18 years and \< 80 years of age and competent to give informed consent.
• Eastern Cooperative Oncology Group performance status ≤ 2.
• Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).
• Women of childbearing potential (WOCBP) should have a negative serum test at screening (Visit 1) and a negative urine pregnancy test at the PET/CT imaging visit (Visit 2) prior to \[18F\]FPyQCP administration.
• WOCBP, and men who are sexually active with WOCBP, must agree to use a highly effective method(s) of contraception for the duration of the study
• Cohort A specific: Participants with stage I-III (see Appendix 3) CRC, GC, PDAC, ILC, or EOC (stage IV disease is allowed in the setting of oligometastatic disease \[5 or fewer known metastases) as assessed by conventional imaging within 8 weeks of \[18F\]FPyQCP administration.
• Cohort B specific: Conventional imaging performed within 8 weeks of screening and no later than 24 hours before \[18F\]FPyQCP administration and available for upload to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.
• Either:
• Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day 42.
• Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42. \[18F\]FPyQCP PET/CT imaging should be performed as close to scheduled procedure as clinically feasible.
• Suspected recurrence after definitive therapy

You may not qualify if:

• Participants administered any radioisotope within 5 physical half-lives prior to \[18F\]FPyQCP administration.
• Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to \[18F\]FPyQCP administration.
• Participants who have recently received any other contrast agent (\< 24 hours for intravenous agents and \< 5 days for oral agents) before the day of \[18F\]FPyQCP administration.
• Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
• Known hypersensitivity to \[18F\]FPyQCP or any of its constituents.
• Participants with any medical condition or other circumstances at screening or in their past medical history that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or study completion.
• Known diagnosis of an autoimmune or inflammatory disorder that is expected to confound image interpretation per investigator judgment, excluding disorders directly related to the index cancer (e.g. tumor-associated pancreatitis or biliary stasis for PDAC).
• Medical history of abdomino-pelvic or breast irradiation in the last 3 months.
• Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgment.
• Significant renal or hepatic impairment.
• Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the \[18F\]FPyQCP administration.

Sponsors & Collaborators

• Blue Earth Diagnostics: lead
• Medpace, Inc.: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinoma, Ovarian Epithelial; Stomach Neoplasms; Carcinoma, Lobular

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Stomach Diseases; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Steven Rowe, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie MacKay, MD, PhD

CONTACT

+447350456887; jamie.mackay@blueearthdx.com

Evgenia Perkins

CONTACT

+19139576499; evgenia.perkins@blueearthdx.com

Study Design

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

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 25, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)