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Glioblastoma MultiformeEarly Phase 1NCT04712721

Study of [68Ga]-FF58 in Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.

A Early Phase 1 study testing 68Ga-FF58 in people with Glioblastoma Multiforme and Brain Neoplasms, run by Novartis Pharmaceuticals at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a First-In-Human (FIH) study of [68Ga]-FF58 to characterize the imaging properties, safety, biodistribution and dosimetry properties of [68Ga]-FF58 in adults with relapsed or refractory (r/r) glioblastoma multiforme (GBM), breast cancer (BC) that has metastasized to the brain, gastroesophageal adenocarcinoma… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
68Ga-FF58
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
2 sitesin 2 countries
Study dates
14 Oct 2021to 1 Jul 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent must be obtained prior to participation in the study
  • Patients with histologically or cytologically confirmed and documented r/r GBM that has progressed after prior radiation therapy and have not received prior bevacizumab OR patients with BC that has metastasized to the brain and who should have at least one newly diagnosed brain metastasis that has not been resected or irradiated, or has been irradiated and progressed OR 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 OR patients with histologically or cytologically confirmed and documented locally advanced or metastatic PDAC, either untreated or r/r after one or more lines of treatment.

Who cannot join

  • Creatinine clearance (calculated using Cockcroft-Gault formula) <40 mL/min.
  • Unmanageable bladder outflow obstruction or urinary incontinence.
  • QTcF > 480 msec on screening ECG or congenital long QT syndrome.
  • Any condition that requires chronic treatment with anticoagulants or antiplatelet agents
  • Patients with a known bleeding disorder
  • Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of [68Ga]-FF58.
Show all 10Show fewer
  • Pregnant women. Women who are breastfeeding must express and discard breast milk for 12 hours after [68Ga]-FF58 administration and must also stop breast feeding during this same period. Males and females must abstain from sexual intercourse for 12 hours after [68Ga]-FF58 administration.
  • Total bilirubin > 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN) or direct bilirubin > 1.5 x ULN
  • Alanine aminotransferase (ALT) > 3 x ULN, except for patients that have tumor involvement of the liver, who are excluded if ALT > 5 x ULN
  • Aspartate aminotransferase (AST) > 3 x ULN, except for patients that have tumor involvement of the liver, who are excluded if AST > 5 x ULN

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

France1 site

  • Novartis Investigative Site

    Lyon, 69373

Other trials in France

Germany1 site

  • Novartis Investigative Site

    Essen, 45147

Other trials in Germany

About this study

Official title: Phase I, Open-label, Multicenter Study to Evaluate the Imaging Performance, Safety, Biodistribution and Dosimetry of [68Ga]-FF58 in Adult Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.

This is a First-In-Human (FIH) study of [68Ga]-FF58 to characterize the imaging properties, safety, biodistribution and dosimetry properties of [68Ga]-FF58 in adults with relapsed or refractory (r/r) glioblastoma multiforme (GBM), breast cancer (BC) that has metastasized to the brain, gastroesophageal adenocarcinoma (GEA) or pancreatic ductal adenocarcinoma (PDAC) expected to overexpress alpha-v beta 3 (αvβ3) and alpha-v beta 5 (αvβ5) integrins.

Read the detailed description

Approximately 80 patients were planned to be enrolled into the study, 20 patients with GBM, 20 patients with BC that had metastasized to the brain, 20 with GEA and 20 with PDAC.

The study included an imaging characterization part and an expansion part. In the imaging characterization part, approximately 24 patients were planned to be enrolled, 6 with r/r GBM, 6 with BC that had metastasized to the brain, 6 with GEA and 6 with PDAC. Due to the early termination of the study, the expansion part was not started.

Both parts of the study (imaging characterization and expansion) included a dosimetry sub-group in which the distribution, pharmacokinetics (PK), radiation dosimetry and absorbed doses in tissue and tumor were to be assessed. However, no patients were enrolled in the dosimetry sub-group.

All patients enrolled in the study received a single dose of [68Ga]-FF58 and underwent [68Ga]-FF58 positron emission tomography (PET) imaging at different timepoints on Day 1 as well as conventional imaging (high resolution computed tomography (CT) or magnetic resonance imaging (MRI)).

The estimated study duration for each individual patient was approximately 44 days (including screening period of 28 days and 14 days of follow-up (FU)).

Being tested
68Ga-FF58
Keywords
Glioblastoma Multiforme, GBM, Breast Cancer, BC, Brain Metastasis from BC, Gastroesophageal adenocarcinoma, GEA, Pancreatic ductal adenocarcinoma, PDAC, alpha-v beta 3 integrin, αvβ3, alpha-v beta 5 integrin, αvβ5, Dosimetry, 68Gallium, 68Ga, FF58, [68Ga]-FF58
Medical subject headings
Glioblastoma, Brain Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-FF58Drug

    Single intravenous radiolabeled gallium FF58 injection determined by body weight (3 Megabecquerel (MBq)/Kg (+/- 10%)). Administered dose must not be lower than 150 MBq or higher than 250 MBq.

Study groups in NCT04712721
Study groupRoleWhat they receive
Glioblastoma MultiformeExperimentalAll 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].
Receives: Drug: 68Ga-FF58
Brain Metastasis from Breast CancerExperimentalAll 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].
Receives: Drug: 68Ga-FF58
Gastroesophageal adenocarcinomaExperimentalAll 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]
Receives: Drug: 68Ga-FF58
Pancreatic ductal adenocarcinomaExperimentalAll 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]
Receives: Drug: 68Ga-FF58

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Time activity curves (TACs) for the various organs will be produced as mean Standard Uptake Values (SUV) of the lesions over time.

    Measured: [68Ga]-FF58 PET imaging acquired at Day 1

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

    Targeting properties of 68GaFF58 will be evaluated by semi quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax of each lesion will be calculated and reported by lesion location with summary statistics.

    Measured: [68Ga]-FF58 PET imaging acquired at Day 1

  3. Tumor to Background Ratio (TBR) of lesions detected by PET scans

    Targeting properties of 68Ga-FF58 will be evaluated by semi quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) will be defined as the ratio of the lesion SUV over the reference region SUV. TBRs will be calculated for both SUVmax(lesion) / SUVmean and reported by lesion location with summary statistics. Different regions will be used as reference, in order to satisfy the most appropriate one for each type of lesion.

    Measured: [68Ga]-FF58 PET imaging acquired at Day 1

Secondary outcomes (13)

  1. Number of Participants with Treatment Emergent Adverse Events

    Treatment-emergent adverse events (TEAEs) will be collected from first dosing (single administration, Day 1) up to last follow-up visit or the patient withdrew consent. The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

    Measured: From first dosing (single administration, Day 1) up to 14 days post infusion

  2. Percentage of lesions detected by conventional scans, PET scans, or both modalities

    The percentage of lesions detected by conventional imaging (high resolution CT or MRI acquired jointly or within 24 hours before or after the [68Ga]-FF58 PET scan), [68Ga]-FF58 PET scans , or both modalities will be summarized descriptively for all patients and split by indication.

    Measured: [68Ga]-FF58 PET imaging acquired at Day 1

  3. Lesion-level analyses of diagnostics by [68Ga]-FF58 compared with conventional imaging

    At lesion level, overall, positive, and negative agreement of [68Ga]-FF58 will be calculated based on the aforementioned tabulations as follows: • Overall agreement = 100% x (Double positive + Double negative) / total number of lesions identified by either imaging procedures

    • Positive agreement = 100% x Double positive / (Double positive + Comparator single positive)
    • Negative agreement = 100% x Double negative / (Double negative + Comparator single negative).

    Measured: [68Ga]-FF58 PET imaging acquired at Day 1

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

    Venous whole blood samples will be collected and analysed for radioactivity. Radioactivity-based concentration units will be converted to mass-based concentration units using the specific activity of the dose at the time of manufacture (MBq/µg). Pharmacokinetics characterization will be performed on mass-based concentrations. AUClast will be listed and summarized using descriptive statistics.

    Measured: Day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion)

  5. Dosimetry Group: Time of maximum observed drug concentration occurrence (Tmax) of 68Ga-FF58

    Venous whole blood samples will be collected and analysed for radioactivity. Radioactivity based concentration units will be converted to mass-based concentration units using the specific activity of the dose at the time of manufacture (MBq/µg). Pharmacokinetics characterization will be performed on mass-based concentrations. Tmax will be listed and summarized using descriptive statistics.

    Measured: Day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion)

  6. Dosimetry Group: Observed maximum plasma concentration (Cmax) of 68Ga-FF58

    Venous whole blood samples will be collected and analysed for radioactivity. Radioactivity based concentration units will be converted to mass-based concentration units using the specific activity of the dose at the time of manufacture (MBq/µg). Pharmacokinetics characterization will be performed on mass-based concentrations. Cmax will be listed and summarized using descriptive statistics.

    Measured: Day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion)

  7. Dosimetry Group: Terminal elimination half-life (T^1/2) of 68Ga-FF58

    Venous whole blood samples will be collected and analysed for radioactivity. Radioactivity based concentration units will be converted to mass-based concentration units using the specific activity of the dose at the time of manufacture (MBq/µg). Pharmacokinetics characterization will be performed on mass-based concentrations. The half-life will be listed and summarized using descriptive statistics.

    Measured: Day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion)

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

    Venous whole blood samples will be collected and analysed for radioactivity. Radioactivity based concentration units will be converted to mass-based concentration units using the specific activity of the dose at the time of manufacture (MBq/µg). Pharmacokinetics characterization will be performed on mass-based concentrations. AUCinf will be listed and summarized using descriptive statistics.

    Measured: Day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion)

  9. Dosimetry Group: Total systemic clearance for intravenous administration (CL) of 68Ga-FF58

    Venous whole blood samples will be collected and analysed for radioactivity. Radioactivity based concentration units will be converted to mass-based concentration units using the specific activity of the dose at the time of manufacture (MBq/µg). Pharmacokinetics characterization will be performed on mass-based concentrations. CL will be listed and summarized using descriptive statistics.

    Measured: Day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion)

  10. Dosimetry Group: Volume of distribution during the terminal phase following intravenous elimination (Vz) of 68Ga-FF58

    Venous whole blood samples will be collected and analysed for radioactivity. Radioactivity based concentration units will be converted to mass-based concentration units using the specific activity of the dose at the time of manufacture (MBq/µg). Pharmacokinetics characterization will be performed on mass-based concentrations. Vz will be listed and summarized using descriptive statistics.

    Measured: Day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion)

  11. Dosimetry Group: Urinary excretion of radioactivity expressed as a percentage of injected activity (%IA)

    Urine samples will be collected over specified time intervals and analysed for radioactivity. The radioactivity excreted in each interval as a percentage of injected activity (%IA) will be listed and summarized using descriptive statistics.

    Measured: Day 1 (0-30, 30-120, 120-180, 180-300 minutes post infusion)

  12. Dosimetry Group: Absorbed dose of 68Ga- FF58

    The absorbed dose in target organs will be summarized with descriptive statistics. Lesion number will be assigned by dosimetry expert.

    Measured: [68Ga]-FF58 PET imaging acquired at Day 1

  13. Dosimetry Group: Effective whole-body dose of 68Ga- FF58

    The effective radiation dose will be summarized with descriptive statistics. Lesion number will be assigned by dosimetry expert.

    Measured: [68Ga]-FF58 PET imaging acquired at Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start14 Oct 2021
  3. Primary completion18 Jun 2024
  4. Study completion1 Jul 2024

Why it stopped: Business reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Imaging study
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04712721
Sponsor's protocol ID
CAAA504A12101
Other IDs
2020-004038-39
Status last verified
Oct 2025
First submitted
11 Dec 2020
Last updated
10 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 68Ga-FF58 in people with Glioblastoma Multiforme and Brain Neoplasms, run by Novartis Pharmaceuticals at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-activity curves (TACs) from 68Ga-FF58 PET/CT images (time frame: [68Ga]-FF58 PET imaging acquired at Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04712721.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.

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