Imaging of Solid Tumors Using FAP-2286

Part of paid clinical trials in San Francisco, California.

Sponsor
Thomas Hope
Study ID
NCT04621435
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastatic Cancer
  • Solid Tumors, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
  • Positron Emission Tomography (PET) imaging — PROCEDURE
    Participants will be scanned for approximately 30 to 45 minutes
  • 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

Study Details

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.

Key Dates

Start date
Dec 14, 2020
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
191 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: CLOSED - 68Ga-Dosimetry population (Cohort 1a)
    PET imaging will begin 30 +/-10 minutes, 60 +/-15 minutes and 120 +/-20 minutes after injection of 68Ga-FAP-2286. Contrast may be administered if clinically indicated.
  • Experimental: CLOSED - 64Cu-Dosimetry population (Cohort 1b)
    PET imaging will begin 60±15 minutes, 240±30 minutes after injection, and a second PET imaging will be performed 24±2 hours after initial injection of 64Cu-FAP-2286. Contrast may be administered if clinically indicated.
  • Experimental: Participants with metastatic disease (Cohort 2)
    Participants with metastatic disease will have PET imaging 50-100 minutes after injection of 68Ga- or 64Cu- FAP-2286. Contrast may be administered if clinically indicated.
  • Experimental: Participants without metastatic disease (Cohort 3)
    Participants without metastatic disease will have PET imaging 50-100 minutes after injection of 68Ga- or 64Cu- FAP-2286. Contrast may be administered if if clinically indicated.

Primary Outcome Measure

Count of participants with treatment-emergent adverse events [ Time Frame: Until end of day on the day of the injection (1 day total) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Maya Aslam
[email protected]
877-827-3222
[email protected]
Thomas Hope, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, San Francisco· San Francisco, CA

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