Clinical trial · Interventional
A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.
A Phase I, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry and Preliminary Activity of [177Lu]Lu-FF58 in Patients With Selected Advanced Solid Tumors.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The decision was not based on any safety concerns
Summary
Brief summary (as posted)
The purpose of the study is to test the safety and dosing of \[177Lu\]Lu-FF58, a radioligand therapy for patients with advanced or metastatic tumors that express proteins known as integrins: alpha-v beta-3 integrin (αvβ3) and alpha-v beta-5 integrin (αvβ5). The study will also further characterize the radioligand imaging agent \[68Ga\]Ga-FF58 including its ability to identify tumor lesions and its safety profile.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroesophageal Adenocarcinoma | — | UNRESOLVED | — |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-FF58 | Drug | — | UNRESOLVED |
| 68Ga-FF58 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Patients will receive 68Ga-FF58 and only patients with tumor uptake of 68Ga-FF58 will receive 177Lu-FF58.
- interventionNames
- Drug: 68Ga-FF58
- Drug: 177Lu-FF58
Primary outcomes (4)
- measure
- Incidence and severity of dose limiting toxicities of 177Lu-FF58
- timeFrame
- From start of study treatment until 6 weeks after
- description
- A dose limiting toxicity (DLT) is defined as any AE or abnormal laboratory value of CTCAE (v5.0) Grade 3 or higher that occurs within the DLT evaluation period (i.e., 6 weeks starting from the first administration of 177Lu-FF58) and that is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications.
- measure
- Incidence and severity of adverse events and serious adverse events of 177Lu-FF58
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Key Inclusion criteria * Age \>= 18 years old * Patients with locally advanced unresectable or metastatic PDAC, locally advanced unresectable or metastatic GEA, or recurrent GBM * To be treated with \[177Lu\]Lu-FF58, patients must have at least one measurable lesion that shows \[68Ga\]Ga-FF58 uptake on PET/CT or PET/MRI Key Exclusion criteria * Absolute neutrophil count (ANC) \< 1.5 x 109/L, hemoglobin \< 10 g/dL, or platelet count \< 100 x 109/L * Prior external beam radiation therapy (EBRT) to \> 25% of the bone marrow * Creatinine clearance \< 60 mL/min * Unmanageable bladder outflow obstruction or urinary incontinence * Non-GBM patients: Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within 1 week before \[177Lu\]Lu-FF58 administration Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available