FAP-2286 Imaging for Cancer

Overseen By Maya Aslam

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Thomas Hope

Disqualifiers: Non-compliance, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

191 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to detect cancer spread in individuals with certain solid tumors. It uses special imaging agents, 68Ga-FAP-2286 and 64Cu-FAP-2286 (types of radiotracers), to enhance the visibility of cancer cells. The goal is to assess how effectively these tracers identify cancer in various tumor types. Individuals with specific cancers, such as breast, prostate, or bladder cancer, whether or not they have metastatic disease, might be suitable candidates. As a Phase 1 trial, this research aims to understand how these new imaging agents function in people, offering participants the chance to be among the first to benefit from this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial team for guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the imaging agent FAP-2286, when combined with either gallium-68 (68Ga) or copper-64 (64Cu), appears safe for humans. A study on 68Ga-FAP-2286 found it well-tolerated, with the highest concentration in the kidneys, which is typical for imaging agents. This indicates it functions as expected without causing unexpected side effects.

For 64Cu-FAP-2286, detailed safety information remains limited, but testing follows a similar approach. Both versions of FAP-2286 are still in early clinical trials, requiring more data to fully understand their safety. However, the continuation of these trials suggests that initial findings support their safety for further testing in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the use of FAP-2286 for cancer imaging because it targets fibroblast activation protein (FAP), which is often overexpressed in cancer-associated fibroblasts. Unlike traditional imaging methods that may not specifically highlight tumor environments, FAP-2286 is designed to bind to these proteins, potentially enhancing the precision of PET scans in detecting and assessing tumors. This targeted approach could lead to more accurate diagnosis and monitoring, helping tailor treatments to individual patient needs.

What evidence suggests that this trial's imaging agents could be effective for detecting metastatic cancer?

Research has shown that FAP-2286 holds promise for detecting solid tumors. In this trial, participants will receive either the 68Ga-FAP-2286 or 64Cu-FAP-2286 tracer. The 68Ga-FAP-2286 tracer has proven very effective at identifying cancer spread, sometimes surpassing traditional FDG PET scans, particularly in lung cancer. It can detect small tumors, even those smaller than 1.0 cm. Early studies on the 64Cu-FAP-2286 tracer also suggest it can locate cancerous areas. Both tracers target the Fibroblast Activation Protein (FAP), often found on cells associated with cancer, making them valuable tools for diagnosing cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Thomas A. Hope, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults with solid tumors, including specific cancers like breast, pancreatic, prostate, bladder, or colon cancer. Participants may be at initial high-risk stages or post-treatment with a risk of recurrence. They must understand and sign consent.

Inclusion Criteria

Ability to understand a written informed consent document, and the willingness to sign it.

My cancer type does not matter and it doesn't need to be measurable for this study group.

My doctor considers my cancer high risk and believes imaging could change my treatment plan.

Exclusion Criteria

Known pregnancy.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET imaging using 68Ga- or 64Cu-FAP-2286 to evaluate uptake and retention in solid tumors

1 week

Multiple imaging sessions within 1 week

Follow-up

Participants are monitored for safety and effectiveness after imaging

Up to 3 days

Follow-up visits for adverse event monitoring

What Are the Treatments Tested in This Trial?

Interventions

• FAP-2286

Trial Overview

The trial tests new imaging agents (68Ga- and 64Cu-FAP-2286) that bind to proteins often found in solid tumors. It aims to see how well these tracers can detect metastatic cancer using PET scans in various patient groups.

How Is the Trial Designed?

Group I: Participants without metastatic disease (Cohort 3) Experimental Treatment 3 Interventions

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.

Group II: Participants with metastatic disease (Cohort 2) Experimental Treatment 3 Interventions

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.

Group III: CLOSED - 68Ga-Dosimetry population (Cohort 1a) Experimental Treatment 2 Interventions

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.

Group IV: CLOSED - 64Cu-Dosimetry population (Cohort 1b) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Thomas Hope

Lead Sponsor

Trials

11

Recruited

1,800+

Society of Abdominal Radiology

Collaborator

Trials

4

Recruited

200+

Society of Abdominal Radiology

Collaborator

Clovis Oncology, Inc.

Industry Sponsor

Trials

65

Recruited

11,100+

Patrick J. Mahaffy

Clovis Oncology, Inc.

Chief Executive Officer since 2009

BA from Haverford College, MBA from Columbia University

Lindsey Rolfe

Clovis Oncology, Inc.

Chief Medical Officer since 2015

Specialist accreditation in pharmaceutical medicine

Published Research Related to This Trial

FAP-2286, a peptide targeting fibroblast activation protein (FAP), showed high affinity and selectivity for FAP in various tumors, including pancreatic and breast cancers, indicating its potential as a targeted imaging and therapeutic agent.

In preclinical studies, 177Lu-FAP-2286 demonstrated significant antitumor activity with minimal side effects, such as weight loss, and outperformed another FAP-targeting agent (FAPI-46) in terms of tumor retention and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical evaluation of FAP-2286 for fibroblast activation protein targeted radionuclide imaging and therapy. Zboralski, D., Hoehne, A., Bredenbeck, A., et al.[2022]

FAPI PET imaging outperformed traditional FDG PET/CT/MRI in detecting tumors and metastases in patients with pancreatic, gastric, and cholangiocarcinoma, based on a systematic review of 10 studies.

FAPI PET provided higher maximum standardized uptake values (SUVmax) and tumor-to-background ratios (TBRmax), indicating its potential for more accurate cancer staging and diagnosis, which supports the need for further clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FAPI PET versus FDG PET, CT or MRI for Staging Pancreatic-, Gastric- and Cholangiocarcinoma: Systematic Review and Head-to-Head Comparisons of Diagnostic Performances. Veldhuijzen van Zanten, SEM., Pieterman, KJ., Wijnhoven, BPL., et al.[2022]

Fibroblast activation protein (FAP) is a promising target for tumor imaging and therapy, as it is found in over 90% of epithelial cancers, making it a specific marker for these tumors with minimal expression in normal tissues.

The use of [68Ga]Ga-FAPI PET/CT in lung cancer shows high uptake and tumor-to-background ratios, outperforming [18F]FDG PET/CT in detecting lung cancer and its metastases, suggesting its potential for better diagnostic and prognostic capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance and Prospects of [68Ga]Ga-FAPI PET/CT Scans in Lung Cancer. Borgonje, PE., Andrews, LM., Herder, GJM., et al.[2023]

FAP-2287, a radiopharmaceutical targeting FAP in tumors, showed significant tumor growth inhibition and improved survival in mice with FAP-expressing tumors when combined with PD-1 antibody treatment.

The treatment increased the infiltration of CD8+ T cells in the tumors and activated immune responses, suggesting that FAP-targeted radiotherapy can enhance the effectiveness of immune checkpoint inhibitors in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fibroblast activation protein targeted radiotherapy induces an immunogenic tumor microenvironment and enhances the efficacy of PD-1 immune checkpoint inhibition. Zboralski, D., Osterkamp, F., Christensen, E., et al.[2023]

In a study involving 120 patients with gastrointestinal cancers, 68Ga-FAPI PET demonstrated a diagnostic accuracy of 95.0%, significantly outperforming conventional imaging and 18F-FDG PET, which had accuracies of 65.1% and 69.0%, respectively.

68Ga-FAPI PET not only provided more accurate staging but also revised treatment plans for 22.9% of patients compared to conventional imaging, highlighting its potential to significantly impact clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. Qin, C., Song, Y., Gai, Y., et al.[2022]

The study evaluated two new PET tracers, 68Ga-FAPI-2 and 68Ga-FAPI-4, in 50 cancer patients, showing that they provide similar or better tumor-to-background contrast compared to the standard 18F-FDG, with no need for dietary restrictions before the scan.

Both tracers demonstrated a low uptake in normal tissues and a rapid clearance via the kidneys, making them promising tools for cancer diagnostics with effective imaging capabilities shortly after injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-FAPI PET/CT: Biodistribution and Preliminary Dosimetry Estimate of 2 DOTA-Containing FAP-Targeting Agents in Patients with Various Cancers. Giesel, FL., Kratochwil, C., Lindner, T., et al.[2021]

In a study involving 64 patients with various cancers, 68Ga-FAP-2286 PET/CT demonstrated significantly higher uptake in primary tumors and metastases compared to the standard 18F-FDG PET/CT, indicating improved diagnostic accuracy.

68Ga-FAP-2286 successfully visualized all primary tumors and showed superior lesion detection rates for lymph node and distant metastases, making it a promising alternative for cancers that typically show low uptake of 18F-FDG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET Imaging of Fibroblast Activation Protein in Various Types of Cancer Using 68Ga-FAP-2286: Comparison with 18F-FDG and 68Ga-FAPI-46 in a Single-Center, Prospective Study. Pang, Y., Zhao, L., Meng, T., et al.[2023]

The novel radiolabeled compound 68Ga-OncoFAP shows high affinity for fibroblast activation protein (FAP) and demonstrates excellent properties for PET imaging, including high tumor uptake and favorable biodistribution in both preclinical and clinical settings.

In a study involving 12 patients, 68Ga-OncoFAP exhibited significant uptake in various cancers, with maximum standardized uptake values (SUVmax) indicating its potential as a powerful alternative to existing FAP tracers for cancer imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational imaging of the fibroblast activation protein (FAP) using the new ligand [68Ga]Ga-OncoFAP-DOTAGA. Backhaus, P., Gierse, F., Burg, MC., et al.[2022]

In a study of 62 patients with pancreatic cancer, 68Ga-FAPI PET imaging demonstrated a significant association with histopathologic fibroblast activation protein (FAP) expression, indicating its potential as a reliable diagnostic tool.

68Ga-FAPI PET showed superior tumor detection rates compared to traditional imaging methods like 18F-FDG PET and contrast-enhanced CT, achieving 100% sensitivity and high positive predictive values, which could lead to better management of pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-Labeled Fibroblast Activation Protein Inhibitor (68Ga-FAPI) PET for Pancreatic Adenocarcinoma: Data from the 68Ga-FAPI PET Observational Trial. Kessler, L., Hirmas, N., Pabst, KM., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04621435

NCT04621435 | Imaging of Solid Tumors Using FAP-2286

Evaluate the uptake and retention of radiotracer in a variety of solid tumors with FAP-2286. Evaluate the ability of FAP-2286 to detect metastatic disease.

2.

jnm.snmjournals.org

jnm.snmjournals.org/content/64/3/386

PET Imaging of Fibroblast Activation Protein in Various Types ...

Overall, the results from this study suggest that 68Ga-FAP-2286 is a promising FAPI molecule for cancer diagnosis, staging, and restaging.

3.

withpower.com

withpower.com/trial/phase-1-neoplasm-metastasis-11-2020-c2765

FAP-2286 Imaging for Cancer

It has shown promising results in identifying primary and metastatic cancer lesions, making it a potentially better diagnostic tool for certain cancer types.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10297281/

FAPI PET/CT Imaging—An Updated Review - PMC

Of these, FAPI-04 was found to be the most promising tracer for theranostic application, having higher effective tumor accumulation (3.0% vs. 1.12% ID/g, ...

5.

nature.com

nature.com/articles/s41598-025-91716-3

Preclinical evaluation of [13xLa]La-FAP-2286 as a novel ...

Cellular studies confirmed high binding affinity (KD = 0.51 ± 0.12 nM) and effective internalization of [13xLa]La-FAP-2286 in FAP + tumor cells.

6.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT04621435

Imaging of Solid Tumors Using FAP-2286

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 ...

7.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT04621435/imaging-of-solid-tumors-using-fap-2286

Imaging of Solid Tumors Using FAP-2286

This is a multi-arm prospective trial that evaluates the ability of a novel imaging radiolabeled agents to detect metastatic cancer in ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12390037/

Emerging PET Imaging Agents and Targeted Radioligand ...

Here, we present recent data on some of the most important emerging molecular targeted agents with their exemplar clinical images, including agents targeting ...