Esophageal Cancer Clinical Trial

A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.

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 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.

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Full 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 positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan to assess eligibility for treatment with [177Lu]Lu-FF58. In the escalation part, different doses of [177Lu]Lu-FF58 will be tested to identify the recommended dose. The expansion part of the study will examine the safety and preliminary efficacy of [177Lu]Lu-FF58 at the recommended dose determined during the escalation part. The end of study will occur when at least 80% of the patients in the expansion part have completed the follow-up for disease progression or discontinued from the study for any reason, and all patients have completed treatment and the 36 month long term follow- up period, or the study is terminated early in which case all patients would also be followed up for safety.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

116

Study ID:

NCT05977322

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 6 Locations for this study

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Massachusetts General Hospital Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Ashley O Meara
Contact
[email protected]
Shadi Abdar Esfahani
Principal Investigator
Novartis Investigative Site
Tel Aviv , 64239, Israel
Novartis Investigative Site
Nijmegen Netherland, 6525 , Netherlands
Novartis Investigative Site
Hospitalet de LLobregat Catalunya, 08907, Spain
Novartis Investigative Site
Madrid , 28034, Spain
Novartis Investigative Site
Geneve 14 , CH 12, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

116

Study ID:

NCT05977322

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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