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Solid Tumors, AdultPhase 1NCT04621435

Imaging of Solid Tumors Using FAP-2286

A Phase 1 study testing Gallium-68 labelled (68Ga-) FAP-2286, Positron Emission Tomography (PET) imaging and Copper-64 labeled (64Cu-) FAP-2286 in people with Solid Tumors, Adult and Metastatic Cancer, run by Thomas Hope at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors, Adult, Metastatic Cancer
What is being tested?
Gallium-68 labelled (68Ga-) FAP-2286, Positron Emission Tomography (PET) imaging and Copper-64 labeled (64Cu-) FAP-2286
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
1 siteUnited States
Study dates
14 Dec 2020to 31 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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=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.
  • Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma, castrate-resistant prostate cancer, bladder cancer, colon cancer, or other cancer type.
Show all 10Show fewer
  • 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.
  • 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.
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maya Aslam contact

877-827-3222

Maya.Aslam@ucsf.edu

United States1 site, 1 recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Maya Aslam, 877-827-3222, Maya.Aslam@ucsf.edu

    cancertrials@ucsf.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Initially the investigator(s) will focus on imaging breast, pancreas, sarcoma, prostate cancer, bladder cancer, colon cancer, and head and neck cancer.

STUDY AIMS

  1. Determine the dosimetry for gallium-68 labelled (68Ga-) and 64Cu- FAP-2286.
  2. Evaluate the uptake and retention of radiotracer in a variety of solid tumors with FAP-2286.
  3. Evaluate the ability of FAP-2286 to detect metastatic disease.

PRIMARY OBJECTIVES

  1. All cohorts: Safety of 68Ga- and 64Cu-FAP-2286.
  2. Cohort 1a: determine the organ dosimetry of 68Ga-FAP-2286.
  3. Cohort 1b: determine the organ dosimetry of 64Cu-FAP-2286.
  4. Cohort 2: To assess the feasibility of detecting tumor uptake using FAP-2286.
  5. Cohort 3: To determine the feasibility of detecting metastatic disease using FAP-2286.

EXPLORATORY OBJECTIVES

  1. To detect the sensitivity of FAP-2286 PET compared to conventional imaging for the detection of metastatic disease, and when available sensitivity compared to Fluorodeoxyglucose (FDG) PET (FDG-PET).
  2. Correlation of FAP-2286 uptake with FAP expression determined by immunohistochemistry.
  3. Compare biodistribution of 68Ga-FAP-2286 and 64Cu-FAP-2286 in normal organs and blood pool based on renal function.
  4. Determine impact of administered dose of FAP-2286 on image quality.
  5. Compare the feasibility of detecting tumor uptake using 68Ga-FAP-2286 and 64Cu-FAP-2286

A repeat radiolabeled FAP-2286 PET may be obtained after initiation of subsequent treatment in order to evaluate changes in PET uptake due to treatment effect. Participants will be followed through the day of the last injection of radiolabeled FAP-2286 for evaluation of adverse events.

Being tested
Gallium-68 labelled (68Ga-) FAP-2286, Positron Emission Tomography (PET) imaging, Copper-64 labeled (64Cu-) FAP-2286
Keywords
PET, 68Ga-FAP-2286, 64Cu-FAP-2286
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called 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) imagingProcedure or surgery

    Also called PET

    Participants will be scanned for approximately 30 to 45 minutes

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

    Also called 64Cu-FAP-2286

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

Study groups in NCT04621435
Study groupRoleWhat they receive
CLOSED - 68Ga-Dosimetry population (Cohort 1a)ExperimentalPET 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.
Receives: Drug: Gallium-68 labelled (68Ga-) FAP-2286; Procedure: Positron Emission Tomography (PET) imaging
CLOSED - 64Cu-Dosimetry population (Cohort 1b)ExperimentalPET 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.
Receives: Procedure: Positron Emission Tomography (PET) imaging; Drug: Copper-64 labeled (64Cu-) FAP-2286
Participants with metastatic disease (Cohort 2)ExperimentalParticipants 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.
Receives: Drug: Gallium-68 labelled (68Ga-) FAP-2286; Procedure: Positron Emission Tomography (PET) imaging; Drug: Copper-64 labeled (64Cu-) FAP-2286
Participants without metastatic disease (Cohort 3)ExperimentalParticipants 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.
Receives: Drug: Gallium-68 labelled (68Ga-) FAP-2286; Procedure: Positron Emission Tomography (PET) imaging; Drug: Copper-64 labeled (64Cu-) FAP-2286

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Count of participants with treatment-emergent adverse events

    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

    Measured: Until end of day on the day of the injection (1 day total)

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

    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

    Measured: Up to 3 days

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

    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.

    Measured: Up to 3 days

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

    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).

    Measured: Up to 3 days

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

    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.

    Measured: Up to 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2020
  2. Study start14 Dec 2020
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
191 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04621435
Sponsor's protocol ID
20929
Other IDs
NCI-2020-11728
Status last verified
Jun 2026
First submitted
3 Nov 2020
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kline B, Yadav S, Seo Y, Ippisch RC, Castillo J, Aggarwal RR, Kelley RK, Behr SC, Flavell RR, Lawhn-Heath C, Melisko M, Rugo HS, Wang V, Yom SS, Ha P, Jiang F, Hope TA. 68Ga-FAP-2286 PET of Solid Tumors: Biodistribution, Dosimetry, and Comparison with 18F-FDG. J Nucl Med. 2024 Jun 3;65(6):938-943. doi: 10.2967/jnumed.123.267281.

    PubMed 38697672

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gallium-68 labelled (68Ga-) FAP-2286, Positron Emission Tomography (PET) imaging and Copper-64 labeled (64Cu-) FAP-2286 in people with Solid Tumors, Adult and Metastatic Cancer, run by Thomas Hope at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maya Aslam (877-827-3222, Maya.Aslam@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04621435, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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