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Spots Global Cancer Trial Database for A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.

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Trial Identification

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

Official Title: 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.

Study ID: NCT05977322

Interventions

68Ga-FF58
177Lu-FF58

Study Description

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 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: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Massachusetts General Hospital Massachusetts General Hospital, Boston, Massachusetts, United States

Novartis Investigative Site, Tel Aviv, , Israel

Novartis Investigative Site, Nijmegen, Netherland, Netherlands

Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Geneve 14, , Switzerland

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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