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 States78 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 range18 Years
SexALL
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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
✓. Adequate bone marrow reserves
✓. 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.
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.
7
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.
✕. 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.
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.