Last Update: Sep 19, 2024
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.
ClinicalTrials.gov Identifier:
Novartis Reference Number:CAAA604A12101
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. 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.

Pancreatic Ductal Adenocarcinoma, Gastroesophageal Adenocarcinoma, Glioblastoma Multiforme
Phase1
Recruiting
116
Oct 06, 2023
Jan 26, 2027
All
18 Years - (Adult, Older Adult)

Interventions

Drug

177Lu-FF58

Solution for injection/infusion
Drug

68Ga-FF58

Kit for radiopharmaceutical preparation of 68Ga- FF58 solution for injection

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 Location

Novartis Investigative Site

Recruiting

Tel Aviv,6423906,Israel

Novartis Investigative Site

Recruiting

Reggio Emilia,RE,42123,Italy

Novartis Investigative Site

Recruiting

Nijmegen,6500hb,Netherlands

Novartis Investigative Site

Recruiting

Hospitalet de LLobregat,Catalunya,08907,Spain

Novartis Investigative Site

Recruiting

Madrid,28034,Spain

Novartis Investigative Site

Recruiting

Geneve 14,Ch 1211,Switzerland

MD Anderson Cancer Center Uni of Te MDACC

Recruiting

Houston,Texas,77030,United States

Jordi Rodon
Martha DeLaney

Stanford University .

Recruiting

Palo Alto,California,94304,United States

Christopher Dominguez
Hong Song

BAMF Health Research

Recruiting

Grand Rapids,Michigan,49503,United States

Brandon Mancini
Judith Collea

Massachusetts General Hospital Massachusetts General Hospital

Recruiting

Boston,Massachusetts,02114,United States

Ashley O Meara
Shadi Abdar Esfahani

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals