Brief 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 dosethe amount of medication taken (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)I.
Intervention / Treatment
- Drug: [111In]-FPI-1547 Injection
- Drug: [225Ac]-FPI-1434 Injection multi-dose
- Biological: FPI-1175 Infusionto slowly introduce/give fluid into a vein
- Drug: [225Ac]-FPI-1434 Injection single-dose
Inclusion Criteria:
- Pathologically documented, definitively diagnosed, advancedat a late stage, far along solid tumoura tissue mass that forms from groups of unhealthy cells 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 Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance status of 0 or 1.
- Life expectancy of greater than 3 months as judged by the treating physician.
- Available tumour tissuea group of cells that work together to perform a function (either archival or fresh biopsyremoval of a section of tissue to analyse for cancer cells) for IGF-1R immunohistochemistry. Submission of the tissue is not required prior to enrollment.
- Adequate heart, kidneya pair of bean-shaped organs in the abdomen that are responsible for filtering excess water and waste products from the blood and converting them into urine to be removed from the body, and liver function
- Adequate bone marrowsoft, spongy tissue found in bones that makes blood cells reserves
- Ability to understand and the willingness to sign a written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. document.Phase 2 Specific
- Histologically and/or cytologically documented diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of locally advanced, inoperable, metastatic, or recurrent solid tumour types: endometrial, cervical, ovarian, TNBC, HER 2-negative breast, HNSCC, ACC, or uveal melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body).
- 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 imagingtests that create detailed images of areas inside the body.