Overview

Imaging of Solid Tumors Using 68Ga-FAP-2286

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
Summary
This is a single arm prospective trial that evaluates the ability of a novel imaging agent gallium-68 labelled (68Ga-) FAP-2286 (68Ga-FAP-2286) to detect metastatic cancer in participants with solid tumors using 68Ga-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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Thomas Hope
Collaborator:
Clovis Oncology, Inc.
Criteria
Inclusion Criteria:

1. Age >= 18 years

2. Histopathologically confirmed solid tumors in one of the following cohorts:

a. Cohort 1 (n=5): Metastatic disease present on conventional imaging defined as
having RECIST 1.1 measurable disease or multiple bone metastases.

i. Agnostic to tumor type. b. Cohort 2 (n=30): Metastatic disease present on
conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone
metastases.

i. Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma,
castrate resistant prostate cancer, bladder cancer, or colon cancer.

c. Cohort 3 (n=30): No evidence of metastatic disease as defined as the absence of
RECIST 1.1 measurable disease or bone metastases.

i. 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.

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.