A Phase 1/2 Study of [225Ac]-FPI-1434 Injection
Advanced Solid Tumours, Endometrial Cancer, Cervical Cancer
About this trial
This is an interventional treatment trial for Advanced Solid Tumours focused on measuring 225-Ac Labelled Humanized Monoclonal Antibody Against IGF-1R, [225Ac]-FPI-1434, IGF-IR Targeted Alpha Therapeutic, IGF-IR Radioligand Therapy, Radiopharmaceuticals
Eligibility Criteria
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.
Phase 2 Specific
- Histologically and/or cytologically documented diagnosis of locally advanced, inoperable, metastatic, or recurrent solid tumour types: endometrial, cervical, ovarian, TNBC, HER 2-negative breast, HNSCC, ACC, or uveal melanoma.
Have measurable disease per RECIST 1.1 Failure to respond to standard systemic therapy, or for whom standard or curative systemic therapy does not exist or is not tolerable.
Imaging Eligibility
- Prior to the initial [225Ac]-FPI-1434 cycle: Sufficient target expression in at least 1 lesion following [111In]-FPI-1547 and SPECT imaging.
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.
- Clinically relevant levels of protein in the urine
- Known or suspected allergies or contraindications to the Investigational Products or any component of the investigational drug formulation.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements.
- Received > 20 Gy prior radiation to large areas of the bone marrow
Sites / Locations
- City of HopeRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Masonic Cancer Center, University of MinnesotaRecruiting
- Roswell Park Comprehensive Cancer Center
- Memorial Sloan Kettering Cancer CenterRecruiting
- Hospital of the University of PennsylvaniaRecruiting
- University of Texas MD Anderson Cancer CenterRecruiting
- Royal Adelaide Hospital
- Austin HospitalRecruiting
- Juravinski Cancer Center - Hamilton Health
- Princess Margaret Cancer Centre
- Centre Hospitalier De I'Universite de MontrealRecruiting
- Quebec University Hospital- Laval
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
[225Ac]-FPI-1434 Single-Dose Escalation
[225Ac]-FPI-1434 Multi-Dose Escalation
FPI-1175 Cold Antibody
[225Ac]-FPI-1434 Multi-Dose
[225Ac]-FPI-1434 treatment with or without pre-administration of FPI-1175 (cold antibody).
Phase 2 Tumour Cohort - Head & Neck Squamous Cell Carcinoma (HNSCC), Endometrial Cancer, Cervical Cancer, Ovarian Cancer, Triple Negative Breast Cancer (TNBC), HER2-negative, Adrenocortical Carcinoma (ACC), Uveal Melanoma, [225Ac]-FPI-1434 treatment with or without pre-administration of FPI-1175 (cold antibody).