A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Expressing Fibroblast Growth Factor Receptor 1

FGFR1 is expressed on cells of various tumors, enabling their development. Currently, there are no reported monoclonal antibodies that block FGFR1, and only one chemically synthesized non-selective pan-FGFR inhibitor has been approved in the treatment of FGFR1-positive relapsed or refractory myeloid/lymphoid neoplasms. OM-RCA-01 is an original innovative targeting drug focused on blocking FGFR1. OM-RCA-01 binds to the extracellular part of FGFR1. The main mechanism of action is blocking the activation processes of FGFR1. In studies, OM-RCA-01 was found to be a high-affinity and specific to FGFR1 antibody, inhibiting the phosphorylation of the receptor and the subsequent intracellular cascade. The amount of human protein in the structure of the humanized antibody is 92.9%. The present clinical trial is a Phase 1b/2, multicenter, open-label, non-randomized, cohort study designed to evaluate the safety and preliminary efficacy of the monoclonal antibody OM-RCA-01 in patients with metastatic solid tumors expressing FGFR1. This study adopts a basket trial design, enrolling patients based on the shared molecular characteristic of FGFR1 expression regardless of tumor histology. This approach enables the assessment of the anti-FGFR1 antibody's activity across multiple tumor types simultaneously. Patients with FGFR1 expression meeting inclusion criteria (see the relevant section) will be enrolled into one of five tumor-specific cohorts: * Renal cell carcinoma (RCC); * Non-small cell lung cancer (NSCLC); * Head and neck cancer (HNC); * Breast cancer (BC); * Prostate cancer (PCa) A total of 58 patients will be included. The study drug is administered intravenously, every 14 days till disease progression (RECIST 1.1) or unexaptable toxicity (CTCAE v.5.0).