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

NCT04712721 | Terminated Early Phase 1 FDA Drug

• 2 other identifiers: CAAA504A121012020-004038-39
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 2

Brief 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 (GEA) or pancreatic ductal adenocarcinoma (PDAC) expected to overexpress alpha-v beta 3 (αvβ3) and alpha-v beta 5 (αvβ5) integrins.

Conditions

Glioblastoma Multiforme; Brain Neoplasms; Gastroesophageal Adenocarcinoma; Pancreatic Ductal Adenocarcinoma

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

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (13)

• Number of Participants with Treatment Emergent Adverse Events

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

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

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

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

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

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

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

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

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

Study Arms (4)

Glioblastoma Multiforme

EXPERIMENTAL

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

Drug: 68Ga-FF58

Brain Metastasis from Breast Cancer

EXPERIMENTAL

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

Drug: 68Ga-FF58

Gastroesophageal adenocarcinoma

EXPERIMENTAL

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

Drug: 68Ga-FF58

Pancreatic ductal adenocarcinoma

EXPERIMENTAL

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

Drug: 68Ga-FF58

Interventions

68Ga-FF58 DRUG

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.

Brain Metastasis from Breast Cancer; Gastroesophageal adenocarcinoma; Glioblastoma Multiforme; Pancreatic ductal adenocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Lyon, 69373, France

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Related Links

• Study Results
• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Imaging study

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: January 15, 2021
• Study Start: October 14, 2021
• Primary Completion: June 18, 2024
• Study Completion: July 1, 2024
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); DE (1)