Status:
TERMINATED
A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Pancreatic Ductal Adenocarcinoma
Gastroesophageal Adenocarcinoma
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
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 b...
Detailed Description
The study will be done in two parts. The first part is called "escalation" and the second part is called "expansion". In both parts of the study, patients will be screened with a \[68Ga\]Ga-FF58 posit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05977322
Start Date
October 6 2023
End Date
December 13 2024
Last Update
December 24 2025
Active Locations (5)
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1
Novartis Investigative Site
Tel Aviv, Israel, 6423906
2
Novartis Investigative Site
Nijmegen, Netherlands, 6500HB
3
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, Spain, 08907
4
Novartis Investigative Site
Madrid, Spain, 28034