What side effects are associated with this type of intervention?

Common treatments for brain tumors, such as glioblastoma multiforme, include surgery, radiation therapy, chemotherapy (e.g., temozolomide), and radioimmunotherapy (e.g., (125)I-mAb 425). Surgery can lead to complications like infection, bleeding, and neurological deficits. Radiation therapy often causes fatigue, skin changes, and potential long-term effects like cognitive decline. Chemotherapy with temozolomide may result in nausea, vomiting, bone marrow suppression, and increased risk of infection. Radioimmunotherapy can cause similar side effects to radiation and chemotherapy, including fatigue, nausea, and potential hematologic toxicity. Radiotracers like [68Ga]-FF58, used for imaging, generally have fewer side effects, but may include mild allergic reactions and radiation exposure risks.

What prior FDA approvals exist?

The FDA has approved several treatments for brain tumors, particularly glioblastoma multiforme (GBM). Notable approvals include temozolomide, an oral chemotherapy drug used in combination with radiation therapy, and bevacizumab, an anti-angiogenic drug that inhibits vascular endothelial growth factor (VEGF). While specific FDA approvals for radiotracers targeting αvβ3 and αvβ5 integrins like [68Ga]-FF58 are not detailed, these integrins are often involved in tumor angiogenesis and metastasis, making them promising targets for imaging and therapeutic interventions in brain tumors.

What other types of research exist?

Promising novel alternatives to [68Ga]-FF58 for brain tumor imaging in 2024 include: 1) [111In]-DOTA-Abegrin™, which targets integrin αvβ3 and has shown high-binding affinity in glioblastoma models. 2) [111In]-labelled internalising anti-integrin alpha 3 antibody GA17, which has demonstrated prolonged retention in glioblastoma cells. These alternatives offer targeted imaging capabilities that could be beneficial for brain tumor patients.

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68Ga-FF58 Imaging for Advanced Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for brain tumors include chemotherapy (e.g., temozolomide), radiation therapy, and targeted therapies such as bevacizumab. Temozolomide works by damaging the DNA of cancer cells, leading to cell death. Radiation therapy uses high-energy particles to destroy cancer cells. Bevacizumab, an antiangiogenic agent, inhibits the formation of new blood vessels that tumors need to grow. The trial [68Ga]-FF58 focuses on imaging using a radiotracer that targets αvβ3 and αvβ5 integrins, which are involved in tumor angiogenesis and metastasis. Understanding these mechanisms helps tailor treatments to disrupt specific pathways critical for tumor growth and spread, potentially improving patient outcomes.

Phase < 1

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologically or cytologically confirmed and documented r/r GBM that has progressed after prior radiation therapy and have not received prior bevacizumab

Patients with histologically or cytologically confirmed and documented locally advanced or metastatic GEA (i.e., adenocarcinoma of the stomach (intestinal subtype), esophagus, or gastroesophageal junction), either untreated or r/r after one or more lines of treatment

Must not have

Creatinine clearance (calculated using Cockcroft-Gault formula) <40 mL/min

Any condition that requires chronic treatment with anticoagulants or antiplatelet agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new imaging agent in adults with advanced cancers. The agent helps make cancer cells visible.

Who is the study for?

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.

What is being tested?

[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.

What are the potential side effects?

As a first-in-human study for [68Ga]-FF58, potential side effects are not fully known but may include reactions related to radiopharmaceuticals such as nausea or allergic responses. Close monitoring will occur due to the investigational nature of this compound.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My breast cancer has spread to my brain and there's at least one new brain tumor that hasn't been treated or has worsened after treatment.

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My pancreatic cancer is advanced or has spread, and it may or may not have been treated before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am on long-term medication for blood thinning.

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My heart's electrical activity is abnormal.

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I have a known bleeding disorder.

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I have severe issues controlling my bladder or emptying it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Standard Uptake Value (SUV) mean and max in lesions detected by PET scans

Time-activity curves (TACs) from 68Ga-FF58 PET/CT images

Positron-Emission Tomography

Secondary study objectives

Dosimetry Group: Absorbed dose of 68Ga- FF58

Dosimetry Group: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of 68Ga-FF58

Dosimetry Group: Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of 68Ga-FF58

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Pancreatic ductal adenocarcinomaExperimental Treatment1 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 MultiformeExperimental Treatment1 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 adenocarcinomaExperimental Treatment1 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 CancerExperimental Treatment1 Intervention

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for brain tumors include chemotherapy (e.g., temozolomide), radiation therapy, and targeted therapies such as bevacizumab. Temozolomide works by damaging the DNA of cancer cells, leading to cell death. Radiation therapy uses high-energy particles to destroy cancer cells. Bevacizumab, an antiangiogenic agent, inhibits the formation of new blood vessels that tumors need to grow. The trial [68Ga]-FF58 focuses on imaging using a radiotracer that targets αvβ3 and αvβ5 integrins, which are involved in tumor angiogenesis and metastasis. Understanding these mechanisms helps tailor treatments to disrupt specific pathways critical for tumor growth and spread, potentially improving patient outcomes.

Analysis of gene profiles in glioma cells identifies potential genes, miRNAs, and target sites of migratory cells.Bioinformatics analysis reveals potential candidate drugs for different subtypes of glioma.