Trials / Terminated
TerminatedNCT05977322
A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.
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.
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 68Ga-FF58 | Kit for radiopharmaceutical preparation of 68Ga- FF58 solution for injection |
| DRUG | 177Lu-FF58 | Solution for injection/infusion |
Timeline
- Start date
- 2023-10-06
- Primary completion
- 2024-12-13
- Completion
- 2024-12-13
- First posted
- 2023-08-04
- Last updated
- 2025-12-24
Locations
5 sites across 4 countries: Israel, Netherlands, Spain, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05977322. Inclusion in this directory is not an endorsement.