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 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)I.
Intervention / Treatment
- Drug: [111In]-FPI-1547 Injection
- Drug: [225Ac]-FPI-1434 Injection multi-dose
- Biological: FPI-1175 Infusion
- Drug: [225Ac]-FPI-1434 Injection single-dose
Inclusion Criteria:
- Pathologically documented, definitively diagnosed, advancedat a late stage, far along 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 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, kidney, 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 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.