An Investigational Scan (FAP-2286 PET) for the Imaging of Solid Tumors

Status: active

This phase I trial evaluates the possible benefits and/or side effects of FAP-2286 positron emission tomography (PET) in imaging patients with solid tumors. Radiopharmaceuticals, such as FAP-2286, involve a small amount of radioactive material that is injected into the vein to aid in imaging different areas of the body. FAP-2286 targets a special protein that has been found in certain types of cancers and solid tumors called fibroblast activation protein-alpha (FAP). Diagnostic procedures, such as PET scans, may help find and diagnose solid tumors. Information learned from this study may benefit other patients in the future by improving the quality and availability of imaging agents.

Inclusion Criteria

Age >= 18 years
Histopathologically confirmed solid tumors in one of the following cohorts * Cohort 1 (n=11): measurable disease is not required for this cohort ** Agnostic to tumor type * Cohort 2 (n=65): Metastatic disease present on conventional imaging defined as having Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable disease or multiple bone metastases ** Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma, castrate-resistant prostate cancer, bladder cancer, or colon cancer ** Pathologically confirmed cancer other than noted above (basket subgroup, n=10) * Cohort 3 (n=55): No evidence of metastatic disease as defined as the absence of RECIST 1.1 measurable disease or bone metastases ** Patients 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. Patients 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 ** Pathologically confirmed head and neck cancer or bladder cancer
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

PRIMARY OBJECTIVES:

I. To determine the safety and tolerability of FAP-2286 in patients with solid tumors as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

II. To determine the organ dosimetry of 68Ga-FAP-2286. (Cohort 1a)

III. To determine the organ dosimetry of 64Cu-FAP-2286. (Cohort 1b)

IV. To assess the feasibility of detecting tumor uptake using FAP-2286. (Cohort 2)

V. To determine the feasibility of detecting metastatic disease using FAP-2286. (Cohort 3)

EXPLORATORY OBJECTIVES:

I. To detect the sensitivity of FAP-2286 PET compared to conventional imaging for the detection of metastatic disease, and when available sensitivity compared to fludeoxyglucose F-18 (FDG)-PET.

II. Correlation of FAP-2286 uptake with FAP expression determined by immunohistochemistry.

III. Compare biodistribution of 68Ga-FAP-2286 in normal organs and blood pool based on renal function.

IV. Determine impact of administered dose of FAP-2286 on image quality.

V. Compare the feasibility of detecting tumor uptake using 68Ga-FAP-2286 and 64Cu-FAP-2286.

OUTLINE: Patients are assigned to 1 of 3 arms.

ARM I: Patients receive FAP-2286 intravenously (IV) and then undergo PET/computed tomography (CT) or PET/magnetic resonance imaging (MRI) at 30, 60, and 120 minutes after receiving FAP-2286.

ARM II: Patients receive FAP-2286 IV and then undergo PET/CT or PET/MRI at 60 minutes, 240 minutes, and 24 hours after receiving FAP-2286.

ARM III: Patients receive FAP-2286 IV and then undergo PET/CT or PET/MRI within 50-100 minutes after receiving FAP-2286.

After completion of study, patients are followed for up to 3 days.

Have a question?
We're here to help

Chat with us: LiveHelp
Call us: 1-800-4-CANCER
(1-800-422-6237)

Which trials are right for you?

Use the checklist in our guide to gather the information you’ll need.

An Investigational Scan (FAP-2286 PET) for the Imaging of Solid Tumors

Inclusion Criteria

Exclusion Criteria

United States

California

San Francisco

Have a question?
We're here to help

Which trials are right for you?

An Investigational Scan (FAP-2286 PET) for the Imaging of Solid Tumors

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

Have a question?We're here to help

Which trials are right for you?

Have a question?
We're here to help