RecruitingPhase 1NCT04621435

Imaging of Solid Tumors Using FAP-2286


Sponsor

Thomas Hope

Enrollment

191 participants

Start Date

Dec 14, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria11

  • 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, or colon cancer.
  • ii. Pathologically confirmed cancer other than noted above (basket subgroup, n=10).
  • 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 definitive 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 or bladder cancer.
  • Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria2

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

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Interventions

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

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

PROCEDUREPositron Emission Tomography (PET) imaging

Participants will be scanned for approximately 30 to 45 minutes

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

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


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT04621435


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