68Ga-FF58 Imaging for Advanced Cancer

No longer recruiting at 3 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Novartis Pharmaceuticals

Must not be taking: Anticoagulants, Antiplatelet agents

Disqualifiers: Bleeding disorder, Pregnancy, Liver dysfunction, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method using a substance called [68Ga]-FF58, a radiotracer, to better understand certain types of advanced cancer. The goal is to assess the effectiveness and safety of this imaging technique for people with specific cancers that have recurred or resist treatment, such as glioblastoma multiforme, breast cancer that has spread to the brain, gastroesophageal adenocarcinoma, or pancreatic ductal adenocarcinoma. The trial seeks participants with these conditions who have not received certain treatments, like bevacizumab for glioblastoma, or have newly diagnosed brain metastasis from breast cancer. As an Early Phase 1 trial, this research focuses on understanding how this new imaging method works in people, offering participants a chance to be among the first to benefit from cutting-edge technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who need ongoing treatment with blood thinners or antiplatelet drugs. It's best to discuss your specific medications with the trial team.

What prior data suggests that [68Ga]-FF58 is safe for imaging in humans?

Research has shown that [68Ga]-FF58 is still being tested for safety in humans. This treatment is in the early testing phase, known as Early Phase 1, where scientists primarily assess its safety for human use.

Since this is the first human trial for [68Ga]-FF58, limited safety information is available. However, reaching this stage suggests some confidence in its potential safety. In these early trials, researchers closely monitor the treatment's behavior in the body and any adverse reactions it may cause.

The studies aim to understand how the body processes the treatment, including its movement through the body and potential side effects. Currently, no detailed reports exist on side effects or how well participants tolerate [68Ga]-FF58, so joining this trial may involve some unknowns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

[68Ga]-FF58 is unique because it uses a radiotracer to help visualize advanced cancers like gastroesophageal adenocarcinoma, brain metastasis from breast cancer, pancreatic ductal adenocarcinoma, and glioblastoma multiforme. Unlike traditional imaging methods, [68Ga]-FF58 is designed to provide clearer images by specifically targeting cancer cells, which could lead to better diagnosis and treatment planning. Researchers are excited about this treatment because it could potentially improve the accuracy of detecting cancer spread and help personalize treatment strategies based on more precise imaging.

What evidence suggests that this imaging method could be effective for advanced cancer?

Research has shown that [68Ga]-FF58 is a promising tool for imaging certain cancers. Gallium-68 is commonly used in scans to clearly show tumors. In this trial, participants with various cancers, such as gastroesophageal adenocarcinoma, brain metastasis from breast cancer, pancreatic ductal adenocarcinoma, and glioblastoma multiforme, will receive [68Ga]-FF58. For patients with breast cancer that has spread to the brain, similar imaging agents have accurately detected tumors. This agent targets specific proteins often found in high amounts in tumors, making them easier to see. Although human data on [68Ga]-FF58 is limited, early studies suggest it could effectively highlight tumors in scans, which is important for diagnosis and treatment planning. ^{1 3 5 6 7}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with certain relapsed or refractory solid tumors like glioblastoma, brain-metastasized breast cancer, gastroesophageal adenocarcinoma, or pancreatic cancer. Participants must have confirmed disease progression after treatment and meet specific health criteria such as adequate kidney function and no severe liver issues.

Inclusion Criteria

My GBM has worsened after radiation and I haven't had bevacizumab.

Signed informed consent must be obtained prior to participation in the study

My cancer is in the stomach, esophagus, or where they meet and is advanced.

Exclusion Criteria

My kidney function, measured by creatinine clearance, is less than 40 mL/min.

I am not pregnant, and if breastfeeding, I can stop for 12 hours after treatment. I agree to abstain from sex for 12 hours post-treatment.

I haven't had radiopharmaceuticals within the time frame of 10 half-lives before getting [68Ga]-FF58.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Imaging Characterization

Participants receive a single dose of [68Ga]-FF58 and undergo PET imaging to evaluate imaging performance, safety, biodistribution, and dosimetry

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [68Ga]-FF58

Trial Overview [68Ga]-FF58 is being tested in this first-in-human study to evaluate its imaging capabilities, safety profile, distribution within the body, and radiation dosage when used in patients with specific types of advanced cancers expected to overexpress αvβ3 and αvβ5 integrins.

How Is the Trial Designed?

Group I: Pancreatic ductal adenocarcinoma Experimental Treatment 1 Intervention

All eligible participants will receive recommended dose of \[68Ga\]FF58 of 3 Megabecquerel (MBq)/Kg (+/-10%) \[but not more than 250 and not less than 150 MBq\]

Group II: Glioblastoma Multiforme Experimental Treatment 1 Intervention

All eligible participants will receive recommended dose of \[68Ga\]-FF58 of 3 Megabecquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].

Group III: Gastroesophageal adenocarcinoma Experimental Treatment 1 Intervention

All eligible participants will receive recommended dose of \[68Ga\]FF58 of 3 Megabecquerel (MBq)/Kg (+/-10%) \[but not more than 250 and not less than 150 MBq\]

Group IV: Brain Metastasis from Breast Cancer Experimental Treatment 1 Intervention

All eligible participants will receive recommended dose of \[68Ga\]-FF58 of 3 Megabecquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

The radiotracer [68Ga]Ga-DATA5m.SA.FAPi can be prepared easily at room temperature and shows high stability and affinity for FAP, making it a promising tool for imaging in cancer diagnostics.

In clinical trials with six prostate cancer patients, [68Ga]Ga-DATA5m.SA.FAPi demonstrated rapid and stable tumor uptake, supporting its potential as an effective diagnostic tool for FAP imaging in tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational assessment of a DATA-functionalized FAP inhibitor with facile 68Ga-labeling at room temperature. Escudero-Castellanos, A., Kurth, J., Imlimthan, S., et al.[2023]

In a study of 38 patients with gastric cancer, [68Ga]Ga-FAPI-04 PET demonstrated a 100% sensitivity for detecting primary gastric cancer, significantly outperforming [18F]-FDG PET, which had an 82% sensitivity.

[68Ga]Ga-FAPI-04 PET also showed higher standardized uptake values (SUVmax) in larger and more advanced tumors, indicating its potential for better diagnosis and staging of gastric cancer compared to [18F]-FDG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of [68&#160;Ga]Ga-FAPI-04 and [18F]-FDG for the detection of primary and metastatic lesions in patients with gastric cancer: a bicentric retrospective study. Jiang, D., Chen, X., You, Z., et al.[2022]

Gallium-68 (68Ga) radiopharmaceuticals are emerging as effective alternatives to traditional 99mTc agents for high-resolution imaging in PET scans, with applications in evaluating organ function and targeting specific tumor biomarkers.

The review emphasizes the importance of standardized production and quality control methods for 68Ga radiopharmaceuticals, which are crucial for their safe and effective clinical use, given their favorable properties like short half-life and ease of radiolabeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good practices for 68Ga radiopharmaceutical production. Nelson, BJB., Andersson, JD., Wuest, F., et al.[2022]

In a study of 20 female patients with breast cancer, 68Ga-FAPI-04 PET/CT demonstrated superior sensitivity (100%) and specificity (95.6%) for detecting primary breast tumors compared to 18F-FDG PET/CT, which had a sensitivity of 78.2% and specificity of 100%.

FAPI PET/CT also outperformed FDG PET/CT in identifying metastases in lymph nodes, liver, bone, and brain, showing significantly higher SUVmax values and tumor-to-background ratios, indicating its effectiveness in detecting smaller lesions and providing clearer imaging results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-FAPI-04 PET/CT, a new step in breast cancer imaging: a comparative pilot study with the 18F-FDG PET/CT. Kömek, H., Can, C., Güzel, Y., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04712721

NCT04712721 | Study of [68Ga]-FF58 in Patients With ... This is a First-In-Human (FIH) study of [68Ga]-FF58 to characterize the imaging properties, safety, biodistribution and dosimetry properties of [68Ga]-FF58 ...

2. withpower.com withpower.com/trial/early-phase-1-glioblastoma-8-2021-b78b7

68Ga-FF58 Imaging for Advanced Cancer In a study of 20 female patients with breast cancer, 68Ga-FAPI-04 PET/CT demonstrated superior sensitivity (100%) and specificity (95.6%) for detecting primary ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12249193/

Current Approaches of Nuclear Molecular Imaging in Breast ... In this narrative review, we aim to summarize recent advancements in nuclear molecular imaging techniques and their applications in BCa management.

4. novctrd.com novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18293

Sponsor Generic Drug Name Trial Indication(s) Protocol ... This was a first in human (FIH) study of [68Ga]Ga-FF58 to characterize the imaging properties, safety, biodistribution, and dosimetry of [68Ga] ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8168821/

The incidence of brain metastases among patients with ... We found that almost one-third of patients with HER2+ or triple negative MBC will develop brain metastases during their lifetime, with a 13% incidence per ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11631097/

Targeted radionuclide therapy for patients with central ... In this cohort, the patients with breast cancer had no brain metastasis. [68Ga]Ga-FAPI PET/CT showed high SUVmax in primary lung cancer and ...

7. patents.google.com patents.google.com/patent/US20240050597A1/en

US20240050597A1 - Radiolabelled alpha-v beta-3 and/or ... This is a phase I, single dose study of [ 68Ga]-Compound to characterize the imaging properties, safety, bio-distribution and dosimetry of [ 68Ga]-Compound in ...