A Phase 1 Study of [225Ac]-FPI-1434 Injection (NCT03746431) | Clinical Trial Compass
TerminatedPhase 1
A Phase 1 Study of [225Ac]-FPI-1434 Injection
Stopped: A strategic decision was made to discontinue the study and prioritize other programs within the portfolio. The study was not discontinued due to safety issues or adverse events related to FPI-1434, FPE-1547, or FPI-1175.
United States, Australia, Canada78 participantsStarted 2019-01-17
Plain-language summary
This is a first-in-human Phase 1/2, non-randomized, multi-centre, open-label clinical study designed to investigate safety, tolerability, PK, and preliminary anti-tumour activity of \[225Ac\]-FPI-1434 (radioimmuno-therapeutic agent) in patients with solid tumours that demonstrate uptake of \[111In\]-FPI-1547 (radioimmuno-imaging agent), and to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of repeat doses of \[225Ac\]-FPI-1434 Injection in patients with solid tumours that demonstrate uptake of \[111In\]-FPI-1547 (radioimmuno-imaging agent).
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.
Inclusion criteria
. Pathologically documented, definitively diagnosed, advanced solid tumour that is refractory to all standard treatment, for which no standard treatment is available, or it is contraindicated, or the patient refuses standard therapy.
. Measurable or evaluable disease in accordance with RECIST 1.1.
. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
. Life expectancy of greater than 3 months as judged by the treating physician.
. Available tumour tissue (either archival or fresh biopsy) for IGF-1R immunohistochemistry. Submission of the tissue is not required prior to enrollment.
. Adequate heart, kidney, and liver function
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
1
Dose Escalation: Incidence of adverse events (AEs).
Timeframe: Approximately one year post final [225Ac]-FPI-1434 Injection.
2
Single-Dose Escalation: Incidence of dose limiting toxicities (DLTs).
Timeframe: 8 weeks.
3
Multi-Dose Escalation: Incidence of DLTs.
Timeframe: 6 weeks.
4
Dose Escalation: Incidence of clinically significant clinical laboratory abnormalities.
Timeframe: Approximately one year post final [225Ac]-FPI-1434 Injection.
5
Dose Escalation: Changes in electrocardiogram (ECG) parameters (PR, QRS, QT, and QTc intervals).
Timeframe: 4 weeks post final [225Ac]-FPI-1434 Injection.
6
Cold Antibody Sub-Study: Changes in uptake of [111In]-FPI-1547 Injection following FPI-1175 Infusion in selected regions of interest on SPECT/CT images.
Timeframe: Within two weeks of the first [111In]-FPI-1547 Injection.
. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
. Systemic therapeutic radiopharmaceutical within 6 months prior to enrollment into this study.
. Contraindications to or inability to perform the required imaging procedures in this study (e.g., inability to lay flat during scan time)
. Uncontrolled brain metastasis, including but not limited to the need for treatment with steroids, surgery or radiation therapy.
. Anticancer therapy (including investigational agents) or external beam radiation therapy within 14 days of the dosing of \[111In\]-FPI-1547
. Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast cancer, cervical cancer, prostate) that have undergone potentially curative therapy are not excluded.
. Residual CTCAE ≥ Grade 2 side effects of prior therapy, with the exception of residual grade 2 alopecia.
. Prior organ transplantation, including stem cell transplantation.
. Any prior treatment with nitrosoureas or actinomycin-D.
Cold Antibody Sub-Study: Changes in radiation dose estimates for selected tissues, organs and whole body both for [111In]-FPI-1547 and [225Ac]-FPI-1434 Injection at various dose levels following FPI-1175 Infusion.
Timeframe: Within two weeks of the first [111In]-FPI-1547 Injection.
8
Evaluate anti-tumour activity of [225Ac]-FPI-1434 regimen
Timeframe: Approximately one year post final [225Ac]-FPI-1434 injection.
9
Objective response rate (ORR) RECIST v1.1.
Timeframe: Approximately one year post final [225Ac]-FPI-1434 Injection.