TerminatedPhase 1

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

Stopped: The decision was not based on any safety concerns

Israel, Netherlands, Spain24 participantsStarted 2023-10-06

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and severity of dose limiting toxicities of 177Lu-FF58

Timeframe: From start of study treatment until 6 weeks after

Incidence and severity of adverse events and serious adverse events of 177Lu-FF58

Timeframe: From start of study treatment until 180 days after the last dose of study treatment, assessed up to approximately 15 months

Dose modifications for 177Lu-FF58

Timeframe: From start of study treatment until last dose of study treatment, assessed up to approximately 36 weeks

Dose intensity for 177Lu-FF58

Timeframe: From start of study treatment until last dose of study treatment, assessed up to approximately 36 weeks

Trial details

NCT IDNCT05977322

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-13

View on ClinicalTrials.gov More Pancreatic Ductal Adenocarcinoma trials

Plain-language summary

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence and severity of dose limiting toxicities of 177Lu-FF58

Timeframe: From start of study treatment until 6 weeks after

Incidence and severity of adverse events and serious adverse events of 177Lu-FF58

Timeframe: From start of study treatment until 180 days after the last dose of study treatment, assessed up to approximately 15 months

Dose modifications for 177Lu-FF58

Timeframe: From start of study treatment until last dose of study treatment, assessed up to approximately 36 weeks

Dose intensity for 177Lu-FF58

Timeframe: From start of study treatment until last dose of study treatment, assessed up to approximately 36 weeks