FAP-2286 PET Imaging for Fibrosis

Overseen By Brad Kline

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Thomas Hope

Disqualifiers: Non-compliance, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent, 68Ga-FAP-2286, to determine its ability to identify fibrosis (thickening or scarring of tissue) in the liver, lungs, and heart. The agent targets a protein common in fibrotic tissues, potentially improving diagnosis. Participants will receive one dose of this agent before undergoing a Positron Emission Tomography (PET) scan to assess its effectiveness. Individuals with confirmed liver cirrhosis, pulmonary fibrosis, or signs of heart fibrosis from certain conditions (such as a recent heart attack or specific heart diseases) might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging agent.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this imaging agent is safe for fibrosis patients?

Research has shown that 68Ga-FAP-2286 is generally safe for humans. Early studies indicate that this imaging agent is well-tolerated and produces high-quality scans, which are crucial for detecting fibrosis—a type of tissue scarring—in organs like the liver, lungs, and heart.

For liver fibrosis, studies have found that 68Ga-FAP-2286 safely and effectively attaches to areas with high fibroblast activity. Fibroblasts are cells that play a key role in fibrosis.

In cases of lung fibrosis, early data suggest that 68Ga-FAP-2286 is safe and can effectively show fibrotic activity. It has also been used to detect lung cancer, demonstrating its potential reliability.

For heart fibrosis, research supports the safety of 68Ga-FAP-2286 in detecting fibrosis related to heart conditions, such as heart failure or the effects of chemotherapy.

Overall, while this is an early-stage trial, existing research suggests that 68Ga-FAP-2286 shows promise in terms of safety for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 68Ga-FAP-2286 because it offers a novel approach to imaging fibrosis using PET scans. Unlike traditional imaging methods, this treatment uses a radiotracer targeting fibroblast activation protein (FAP), which is highly expressed in fibrotic tissues. This could potentially allow for more precise and earlier detection of fibrosis in the liver, lungs, and heart. By specifically targeting FAP, 68Ga-FAP-2286 may improve diagnostic accuracy and enable more personalized treatment plans for patients.

What evidence suggests that 68Ga-FAP-2286 is effective for identifying fibrosis?

Research has shown that 68Ga-FAP-2286 holds promise for detecting fibrosis, a condition where tissue becomes thick and scarred, in various organs. This trial will evaluate 68Ga-FAP-2286 across different cohorts, each focusing on a specific type of fibrosis. Participants with liver fibrosis, part of one cohort, will receive a single administration of 68Ga-FAP-2286 before PET imaging. Early results suggest this method could serve as a useful non-invasive evaluation tool. Another cohort will focus on lung fibrosis, where the imaging technique is highly sensitive, effectively detecting changes. In the heart, participants with myocardial fibrosis will be assessed, as 68Ga-FAP-2286 PET imaging shows potential for diagnosing and predicting heart issues related to fibrosis. These findings suggest that 68Ga-FAP-2286 could effectively identify fibrosis in different organs. ^{4 6 7 8 9}

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 confirmed pathologic fibrosis affecting the liver, lungs, or heart. Participants must understand and sign a consent form. It's not suitable for pregnant individuals or those unlikely to follow the trial procedures.

Inclusion Criteria

You have confirmed fibrosis in your liver, lungs, or heart, or have certain heart conditions, and you are able to understand and sign the consent form.

Exclusion Criteria

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

Known pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single administration of 68Ga-FAP-2286 prior to PET imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and safety for up to 31 days

31 days

What Are the Treatments Tested in This Trial?

Interventions

• 68Ga-FAP-2286
• Positron Emission Tomography (PET)

Trial Overview The study tests a new imaging agent called 68Ga-FAP-2286 using PET scans to detect fibrosis in the liver, lungs, and heart. The agent binds to proteins that are more common in these types of fibrosis.

How Is the Trial Designed?

Group I: Cohort 3: Myocardial Fibrosis Experimental Treatment 2 Interventions

Patients with myocardial fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.

Group II: Cohort 2: Pulmonary Fibrosis Experimental Treatment 2 Interventions

Patients with pulmonary fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.

Group III: Cohort 1: Liver Fibrosis Experimental Treatment 2 Interventions

Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.

Who Is Running the Clinical Trial?

Thomas Hope

Lead Sponsor

Trials

11

Recruited

1,800+

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

In a study of 32 cancer patients undergoing Ga-68 FAPI PET scans, 18.8% showed increased myocardial uptake of the tracer, indicating potential cardiac involvement that may be linked to underlying coronary artery disease (CAD).

The study found significant correlations between myocardial FAPI uptake and factors such as age, coronary artery disease, and left ventricular ejection fraction, suggesting that FAPI imaging could help in assessing cardiac risk and monitoring heart health in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac fibroblast activation detected by Ga-68 FAPI PET imaging as a potential novel biomarker of cardiac injury/remodeling. Siebermair, J., Köhler, MI., Kupusovic, J., et al.[2023]

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]

The first-in-human study of 177Lu-FAP-2286 for peptide-targeted radionuclide therapy (PTRT) in 11 patients with advanced adenocarcinomas showed that the treatment was well tolerated, with no severe adverse effects reported.

177Lu-FAP-2286 demonstrated significant tumor uptake and retention, leading to high absorbed doses in tumors, particularly in bone metastases, suggesting its potential efficacy in treating various cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Biodistribution, and Preliminary Dosimetry in Peptide-Targeted Radionuclide Therapy of Diverse Adenocarcinomas Using 177Lu-FAP-2286: First-in-Humans Results. Baum, RP., Schuchardt, C., Singh, A., et al.[2022]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40048016/

Efficacy of [68Ga]Ga-FAPI-PET as a non-invasive ... These preliminary observational results suggest that FAPI-PET may be a viable non-invasive method to asses liver fibrosis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05180162?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Clovis%20Oncology,%20Inc.%22)&viewType=Table&rank=10

Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286 Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging. Intervention/Treatment, Drug : 68Ga-FAP-2286. A dose ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/65/6/938

68Ga-FAP-2286 PET of Solid Tumors: Biodistribution ... 68 Ga-FAP-2286 PET had consistently higher uptake than 18 F-FDG PET. These results are especially promising in the setting of small-volume disease.

4. nature.com nature.com/articles/s44303-024-00053-z

Clinical applications of fibroblast activation protein inhibitor ... This article summarizes the current state of clinical FAPI-PET imaging as well as potential uses as a theranostic agent.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10071807/

PET Imaging of Fibroblast Activation Protein in Various ... Compared with 18F-FDG, 68Ga-FAP-2286 PET/CT detected a greater number of metastatic lesions or a larger disease extent in 12 patients (12/44, 27%), including 4 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05180162

Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286 Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging. Intervention/Treatment, Drug : 68Ga-FAP-2286. A dose ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/63/supplement_2/2279

First-in-human evaluation of 68Ga-FAP-2286, a fibroblast ... In summary, our preliminary data demonstrates that 68Ga-FAP-2286 is safe and produces diagnostic quality scans that could aid in the detection ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9399058/

Preclinical evaluation of FAP-2286 for fibroblast activation ... In preclinical models, radiolabeled FAP-2286 demonstrated high tumor uptake and retention, as well as potent efficacy in FAP-positive tumors.

9. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.220749

FAPI PET: Fibroblast Activation Protein Inhibitor Use in ... For liver fibrosis, elevated FAP expression in hepatic stellate cells was identified in the periseptal areas of the cirrhotic liver ...