Recruiting
Phase 1

FAP-2286

Sponsor:

Thomas Hope

Code:

NCT04621435

Conditions

Solid Tumors, Adult

Metastatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gallium-68 labelled (68Ga-) FAP-2286

Positron Emission Tomography (PET) imaging

Copper-64 labeled (64Cu-) FAP-2286

Study Details

Brief summary:

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.

Conditions

Solid Tumors, Adult

Metastatic Cancer

Study ID

NCT04621435

Start date

Dec 14, 2020

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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, 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.
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.

Study Design

Enrollment

191 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Gallium-68 labelled (68Ga-) FAP-2286

The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging

Positron Emission Tomography (PET) imaging

Participants will be scanned for approximately 30 to 45 minutes

Copper-64 labeled (64Cu-) FAP-2286

The dose will be 3.5 to 5.5 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging

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) ]
  • Proportion of radiation-absorbed doses of radiolabeled FAP-2286 (Cohorts 1a/1b only) [ Time Frame: Up to 3 days ]
  • Standardized Uptake Values (SUVs) (Cohort 2 only) [ Time Frame: Up to 3 days ]
  • Tumor-to-background (TBR) Ratio (Cohort 2 only) [ Time Frame: Up to 3 days ]
  • Proportion of positive lesions on FAP-2286 PET (Cohort 3 only) [ Time Frame: Up to 3 days ]

Central Contacts and Locations

Central contacts

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Thomas Hope, MD

More Information

Sponsor

Thomas Hope

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • PET
  • 68Ga-FAP-2286
  • 64Cu-FAP-2286

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Thomas Hope on 2026-06-04.