Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

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Source: NCT04621435

Recruiting

Imaging of Solid Tumors Using FAP-2286

Metastatic CancerSolid Tumors, Adult

Phase 1

University of California, San Francisco

United States of America

Sponsor: Thomas Hope

Last Updated: December 31, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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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Study Type

Diagnostic

Radiation

Positron

Radiopharmaceutical

Cu-64 FAP-2286, Ga-68 FAP-2286

Target

FAP

Trial Started

December 14, 2020

Last Updated by Sponsor

December 31, 2025

Estimated Completion

December 31, 2026

Eligibility

Inclusion Criteria

1. Age >= 18 years.

2. 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.

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

Exclusion Criteria

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

2. Known pregnancy.

Design Details

AllocationNon-Randomized

Intervention ModelParallel Assignment

MaskingNone (Open Label)

Number to Enroll191

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: 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.

Interventions:

Gallium-68 labelled (68Ga-) FAP-2286
Positron Emission Tomography (PET) imaging
Copper-64 labeled (64Cu-) FAP-2286

Outcome Measures

Primary Outcome Measures

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

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

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

Count of participants with treatment-emergent adverse eventsUntil 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

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

Secondary Outcome Measures

None

Trial Sites

This study has 1 trial site

University of California, San Francisco
San Francisco, California, US

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