Imaging of Solid Tumors Using FAP-2286

Recruiting now · Phase 1

Conditions studied: Solid Tumors, Adult, Metastatic Cancer

In brief

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 facts

Study ID

NCT04621435

Run by

Thomas Hope

People needed

191

Starts

2020-12-14

Expected to finish

2026-12-31

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• University of California, San Francisco — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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