Imaging of Solid Tumors Using FAP-2286

Last updated: November 18, 2024
Sponsor: Thomas Hope
Overall Status: Active - Recruiting

Phase

1

Condition

Metastatic Cancer

Neoplasm Metastasis

Treatment

Gallium-68 labelled (68Ga-) FAP-2286

Copper-64 labeled (64Cu-) FAP-2286

Positron Emission Tomography (PET) imaging

Clinical Study ID

NCT04621435
20929
NCI-2020-11728
  • Ages > 18
  • All Genders

Study Summary

This is a multi-arm prospective trial that evaluates the ability of a novel imaging radiolabeled agents to detect metastatic cancer in participants with solid tumors using a gallium 68 (68Ga-) or copper 64 (64Cu-) FAP-2286 tracer. FAP-2286 is a peptidomimetic molecule that that binds to Fibroblast Activation Protein (FAP). FAP is a transmembrane protein expressed on cancer-associated fibroblasts, and has been shown to be present on a number of solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age >= 18 years

  2. Histopathologically confirmed solid tumors in one of the following cohorts: a. Cohort 1 (n=16): measurable disease is not required for this cohort. i. Agnosticto tumor type. b. Cohort 2 (n=40): Metastatic disease present on conventionalimaging defined as having RECIST 1.1 measurable disease or multiple bone metastases. i. Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma,castrate-resistant prostate cancer, bladder cancer, or colon cancer. ii. Pathologically confirmed cancer other than noted above (basket subgroup, n=10). c. Cohort 3 (n=30): No evidence of metastatic disease as defined as the absence ofRECIST 1.1 measurable disease or bone metastases. i. Patients can be imaged at initial staging with what is judged by the treatingphysician to be high risk disease and where the presence of metastatic disease wouldgreatly impact treatment planning and prognosis. Patients may also be imaged afterdefinitive therapy (surgery, chemotherapy or radiation therapy) if in thedetermination of the treating physician or investigator there is a high risk ofdisease recurrence that would also impact treatment plan and/or prognosis. ii. Pathologically confirmed head and neck cancer or bladder cancer.

  3. Ability to understand a written informed consent document, and the willingness tosign it.

Exclusion

Exclusion Criteria:

  1. Unlikely to comply with protocol procedures, restrictions and requirements andjudged by the Investigator to be unsuitable for participation.

  2. Known pregnancy.

Study Design

Total Participants: 131
Treatment Group(s): 3
Primary Treatment: Gallium-68 labelled (68Ga-) FAP-2286
Phase: 1
Study Start date:
December 14, 2020
Estimated Completion Date:
December 31, 2025

Study Description

Initially the investigator(s) will focus on imaging breast, pancreas, sarcoma, prostate cancer, bladder cancer, colon cancer, and head and neck cancer.

STUDY AIMS

  1. Determine the dosimetry for gallium-68 labelled (68Ga-) and 64Cu- FAP-2286.

  2. Evaluate the uptake and retention of radiotracer in a variety of solid tumors with FAP-2286.

  3. Evaluate the ability of FAP-2286 to detect metastatic disease.

PRIMARY OBJECTIVES

  1. All cohorts: Safety of 68Ga- and 64Cu-FAP-2286.

  2. Cohort 1a: determine the organ dosimetry of 68Ga-FAP-2286.

  3. Cohort 1b: determine the organ dosimetry of 64Cu-FAP-2286.

  4. Cohort 2: To assess the feasibility of detecting tumor uptake using FAP-2286.

  5. Cohort 3: To determine the feasibility of detecting metastatic disease using FAP-2286.

EXPLORATORY OBJECTIVES

  1. To detect the sensitivity of FAP-2286 PET compared to conventional imaging for the detection of metastatic disease, and when available sensitivity compared to Fluorodeoxyglucose (FDG) PET (FDG-PET).

  2. Correlation of FAP-2286 uptake with FAP expression determined by immunohistochemistry.

  3. Compare biodistribution of 68Ga-FAP-2286 and 64Cu-FAP-2286 in normal organs and blood pool based on renal function.

  4. Determine impact of administered dose of FAP-2286 on image quality.

  5. Compare the feasibility of detecting tumor uptake using 68Ga-FAP-2286 and 64Cu-FAP-2286

A repeat radiolabeled FAP-2286 PET may be obtained after initiation of subsequent treatment in order to evaluate changes in PET uptake due to treatment effect. Patients will be followed for up to 3 days after the injection of radiolabeled ligand for evaluation of adverse events.

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

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