TerminatedPhase 1

A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours

Stopped: Sponsor reprioritization of active trials.

United States, Australia19 participantsStarted 2023-02-07

Plain-language summary

This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of \[225Ac\]-FPI-2059 and \[111In\]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours.

Who can participate

Age range

18 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: * Signed ICF prior to initiation of any study-specific procedures * Histologically and/or cytologically confirmed solid tumor that is metastatic or locally advanced, inoperable, or recurrent. Solid tumors indications may include PDAC, CRC, NED prostate cancer, gastric cancer, SCCHN, and Ewing sarcoma. * Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the patient refuses standard therapy * Measurable disease per RECIST v.1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Sufficient target expression in at least one measurable lesion as determined by imaging following injection of \[111In\]-FPI-2058 * Adequate organ function * Tumor tissue (either archival within the last 24 months or fresh biopsy) Key Exclusion Criteria: * Previous treatment with any radiopharmaceutical * Contraindications to or inability to perform the imaging procedures required in this study * Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents within certain amount of time prior to administration of the first dose of \[111In\]-FPI-2058 * Radiation therapy (RT) within 28 days prior to the first dose of \[111In\]-FPI-2058 * Patients with known CNS metastatic disease * Concurrent severe and/or uncontrolled illness that would limit compliance with study requirements * Known or…

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 of Adverse Events to evaluate safety and tolerability of [225Ac]-FPI-2059 and [111In]-FPI-2058

Timeframe: approximately 5 years post final administration

Maximum tolerated dose (MTD) of [225Ac]-FPI-2059

Timeframe: 56 days post administration

Radiation dose of [111In]-FPI-2058 and [225Ac]-FPI-2059 to whole body, organs, and selected regions of interest

Timeframe: within 56 days of administration

Trial details

NCT IDNCT05605522

Sponsor3B Pharmaceuticals GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-19

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