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

NCT ID: NCT05977322

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-06

Study Completion Date

2024-12-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Ductal Adenocarcinoma Gastroesophageal Adenocarcinoma Glioblastoma Multiforme

Keywords

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pancreatic ductal adenocarcinoma PDAC pancreatic cancer gastroesophageal adenocarcinoma GEA gastric cancer gastric adenocarcinoma esophageal cancer esophageal adenocarcinoma glioblastoma multiforme GBM advanced solid tumors radioligand therapy RLT [177Lu]Lu-FF58 [68Ga]Ga-FF58 integrins alpha-v beta-3 integrin αvβ3 alpha-v beta-5 integrin αvβ5

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Patients will receive 68Ga-FF58 and only patients with tumor uptake of 68Ga-FF58 will receive 177Lu-FF58.

Group Type EXPERIMENTAL

68Ga-FF58

Intervention Type DRUG

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

177Lu-FF58

Intervention Type DRUG

Solution for injection/infusion

Interventions

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68Ga-FF58

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

Intervention Type DRUG

177Lu-FF58

Solution for injection/infusion

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Tel Aviv, , Israel

Site Status

Novartis Investigative Site

Nijmegen, , Netherlands

Site Status

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Geneva, , Switzerland

Site Status

Countries

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Italy United States Israel Netherlands Spain Switzerland

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18377

CAAA604A12101 Clinical Trial Results

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=3008

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

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2020-502367-37-00

Identifier Type: OTHER

Identifier Source: secondary_id

CAAA604A12101

Identifier Type: -

Identifier Source: org_study_id