Clinical trial · Interventional
Study of [68Ga]-FF58 in Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business reasons
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Gastroesophageal Adenocarcinoma | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FF58 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Glioblastoma Multiforme
- description
- All eligible participants will receive recommended dose of \[68Ga\]-FF58 of 3 Megabecquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
- interventionNames
- Drug: 68Ga-FF58
- type
- EXPERIMENTAL
- label
- Brain Metastasis from Breast Cancer
- description
- All eligible participants will receive recommended dose of \[68Ga\]-FF58 of 3 Megabecquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
- interventionNames
- Drug: 68Ga-FF58
- type
- EXPERIMENTAL
- label
- Gastroesophageal adenocarcinoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available