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

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.