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

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses a special imaging agent to detect scarring in the liver, lungs, and heart. It targets patients with these specific types of scarring because traditional imaging might not be as effective. The agent works by binding to a protein found in scarred tissues, making them visible on a PET scan.

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 data supports the effectiveness of the drug 68Ga-FAP-2286 for fibrosis?

Research shows that similar drugs like 68Ga-FAPI-04 have been effective in imaging fibrosis in conditions like chronic kidney disease and Crohn's disease, and in staging liver fibrosis. This suggests that 68Ga-FAP-2286 could also be effective for imaging fibrosis. ^{1 2 3 4 5}

Is FAP-2286 PET imaging safe for humans?

FAP-2286 PET imaging has been tested in humans and was generally well tolerated with no severe side effects reported. Some patients experienced mild side effects like pain flare-up, but overall, it showed acceptable safety in studies involving cancer patients. ^{1 6 7 8 9}

How is the drug 68Ga-FAP-2286 unique for imaging fibrosis?

68Ga-FAP-2286 is unique because it targets fibroblast activation protein (FAP), which is overexpressed in activated fibroblasts associated with fibrosis. This allows for more precise imaging of fibrosis compared to traditional methods, potentially improving the noninvasive staging of liver fibrosis. ^{2 4 8 9 10}

Research Team

Thomas A Hope, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Value of [68Ga]Ga-FAPI-04 imaging in the diagnosis of renal fibrosis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Staging Liver Fibrosis by Fibroblast Activation Protein Inhibitor PET in a Human-Sized Swine Model. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[68Ga]Ga-FAPI-04 PET/CT on assessing Crohn's disease intestinal lesions. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

68Ga-FAPI-04 Versus 18F-FDG PET/CT in the Detection of Hepatocellular Carcinoma. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

State-of-the-art of FAPI-PET imaging: a systematic review and meta-analysis. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

68Ga-FAPI PET visualize heart failure: from mechanism to clinic. [2023]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cardiac fibroblast activation detected by Ga-68 FAPI PET imaging as a potential novel biomarker of cardiac injury/remodeling. [2023]

9. United States 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. [2021]

10. United States 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. [2023]