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NCT Number: NCT04621435

Imaging of Solid Tumors Using FAP-2286

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.

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Key information

Conditions

Solid Tumors, Adult Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Maya Aslam

CONTACT

[email protected]

877-827-3222

Thomas Hope, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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

STUDY AIMS

  • Determine the dosimetry for gallium-68 labelled (68Ga-) and 64Cu- FAP-2286.
  • Evaluate the uptake and retention of radiotracer in a variety of solid tumors with FAP-2286.
  • Evaluate the ability of FAP-2286 to detect metastatic disease.

PRIMARY OBJECTIVES

  • All cohorts: Safety of 68Ga- and 64Cu-FAP-2286.
  • Cohort 1a: determine the organ dosimetry of 68Ga-FAP-2286.
  • Cohort 1b: determine the organ dosimetry of 64Cu-FAP-2286.
  • Cohort 2: To assess the feasibility of detecting tumor uptake using FAP-2286.
  • Cohort 3: To determine the feasibility of detecting metastatic disease using FAP-2286.

EXPLORATORY OBJECTIVES

  • 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).
  • Correlation of FAP-2286 uptake with FAP expression determined by immunohistochemistry.
  • Compare biodistribution of 68Ga-FAP-2286 and 64Cu-FAP-2286 in normal organs and blood pool based on renal function.
  • Determine impact of administered dose of FAP-2286 on image quality.
  • 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. Participants will be followed through the day of the last injection of radiolabeled FAP-2286 for evaluation of adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18 years.
  • Histopathologically confirmed solid tumors in one of the following cohorts:

a. Cohort 1 (n=11): measurable disease is not required for this cohort.

i. Agnostic to tumor type.

b. Cohort 2 (n=95): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases. Note: Presence of absence of metastatic disease for eligibility determination will be assessed by reviewing medical records. Screening imaging will not be conducted for this study.

i. Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma, castrate-resistant prostate cancer, bladder cancer, colon cancer, or other cancer type.

c. Cohort 3 (n=85): No evidence of metastatic disease as defined as the absence of RECIST 1.1 measurable disease or bone metastases. Note: Presence of absence of metastatic disease for eligibility determination will be assessed by reviewing medical records. Screening imaging will not be conducted for this study.

i. Participants can be imaged at initial staging with what is judged by the treating physician to be high risk disease and where the presence of metastatic disease would greatly impact treatment planning and prognosis. Participants may also be imaged after therapy (surgery, chemotherapy or radiation therapy) if in the determination of the treating physician or investigator there is a high risk of disease recurrence that would also impact treatment plan and/or prognosis.

ii. Pathologically confirmed head and neck cancer, bladder cancer, or other cancer type.

  • Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

  • Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
  • Known pregnancy.

Treatment and study plan

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

Drug

The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging

Other names: 68Ga-FAP-2286

Positron Emission Tomography (PET) imaging

Procedure

Participants will be scanned for approximately 30 to 45 minutes

Other names: PET

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

Drug

The dose will be 3.5 to 5.5 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging

Other names: 64Cu-FAP-2286

Primary outcomes

  1. Count of participants with treatment-emergent adverse events

    Time frame: Until end of day on the day of the injection (1 day total)

    The frequency and severity of treatment emergent adverse events following FAP-2286 injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

  2. Proportion of radiation-absorbed doses of radiolabeled FAP-2286 (Cohorts 1a/1b only)

    Time frame: Up to 3 days

    Volumes of interest of 68Ga- and 64Cu- will be drawn around regions identified on the scans, including the liver, spleen, kidneys, urinary bladder, the central sacrum (for hematopoietic marrow) and whole body. Data will be fitted using the Simulation, Analysis, and Modeling Software II (SAAM II) software. Time integrals of activity will be entered into the Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA/EXM) software, using the reference adult model. The results from all patients enrolled will be combined to allow the calculation of mean, standard deviation (SD), and range of radiation-absorbed doses to individual organs

  3. Standardized Uptake Values (SUVs) (Cohort 2 only)

    Time frame: Up to 3 days

    The maximum Standardized Uptake Value (SUVmax) will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity.

  4. Tumor-to-background (TBR) Ratio (Cohort 2 only)

    Time frame: Up to 3 days

    TBR ratios will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity. The median and range of the measured TBRs will be reported across all RECIST measurable lesions as a table broken down by location (organ metastases, nodal metastases and bone metastases).

  5. Proportion of positive lesions on FAP-2286 PET (Cohort 3 only)

    Time frame: Up to 3 days

    Conventional imaging or CT portion of PET/CT scan will be reviewed in conjunction with the FAP-2286 PET images. Lesions will be characterized as positive on FAP-2286 PET if uptake is greater than 1.5 times higher than mediastinal blood pool and uptake cannot be attributed to physiologic or inflammatory reasons. Conventional imaging or CT portion of PET/CT scan will be interpreted as positive by each lesion if the short axis dimension of lymph nodes is greater than 1 centimeter (cm), and organ metastases measure greater than 1 cm in long axis. The gold standard will be the combination of conventional imaging and FAP-2286 PET in combination with clinical follow-up and histopathology (if available). The number of lesions detected by each modality will be compared and sensitivity will be computed. Since this is a proof-of-concept study, it is not powered for the test of agreement. Nevertheless, the agreement will be tested using McNemar's test.

Study contacts

Contact information is provided by the study sponsor or research team.

Maya Aslam

CONTACT

[email protected]

877-827-3222

Sponsors and collaborators

Lead sponsor

Thomas Hope

Other

Collaborators

  • Society of Abdominal Radiology

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Nov 9, 2020
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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