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

Inclusion criteria

• Signed and dated Informed Consent Form confirming voluntary participation in the study.
• Age ≥ 18 years at the time of consent.
• Body weight ≥ 50 kg.
• Histologically confirmed metastatic solid tumors:
• clear-cell renal cell carcinoma;
• non-small cell lung cancer (adenocarcinoma or squamous cell cancer without EGFR and ALK mutations);
• prostate cancer (castration-resistant adenocarcinoma);
• breast cancer (adenocarcinoma with specified status for estrogen receptors, progesterone receptors, HER2);
• head and neck tumors (squamous carcinoma, salivary gland cancer).
• Immunohistochemical expression of FGFR1 of 2+ or higher.
• Documented disease progression after at least two lines of standard therapy, or lack of available or feasible alternative standard treatment options for any reason.
• Presence of at least one measurable lesion according to RECIST 1.1 criteria.
• Availability of formalin-fixed and paraffin-embedded tumor tissue samples for biomarker analysis.
• ECOG performance status 0 or 1.
• Adequate organ function, confirmed by laboratory test results obtained within 7 days prior to Cycle 1 Day 1, meeting the following parameters:
• Hemoglobin level ≥ 90 g/L
• Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
• Platelet count ≥ 100 × 10⁹/L
• Serum creatinine level ≤ 1.5 × upper limit of normal (ULN)
• Glomerular Filtration Rate (GFR) ≥ 30 mL/min
• AST and ALT ≤ 3 × ULN (≤ 5 × ULN in patients with liver metastases)
• Serum phosphorus within normal limits (≥ lower limit of normal and ≤ upper limit of normal)
• Serum calcium ≥ lower limit of normal
• Serum potassium ≥ lower limit of normal (note: use of medications to increase potassium during screening is permitted)
• Life expectancy of more than 12 weeks.
• Absence of any psychological, familial, social or geographical circumstances that could potentially serve as an obstacle to the fulfillment of the study protocol and follow-up procedures according to the prescribed schedule and the ability of the study participant to follow the requirements of the protocol; these circumstances should be discussed with the patient before inclusion in the study.
• Women capable of childbearing must be using an effective method of contraception.

Exclusion criteria

• Participation in another clinical trial or concomitant treatment with any investigational drug, or administration of any investigational anticancer therapy within 28 days prior to inclusion in this study.
• Presence of central nervous system (CNS) metastases and/or medullary carcinomatosis at the time of inclusion.
• Exception: Patients with CNS metastases who have received therapy may participate if they have been clinically stable for at least 1 month prior to enrollment, defined by:
• No evidence of new or progressive CNS metastases
• No ongoing steroid therapy
• Stable mental status sufficient to provide informed consent
• History of or current evidence of any condition, therapy, or laboratory abnormality that could:
• Limit interpretation of study results,
• Prevent completion of the study protocol, or
• Pose a risk to patient safety or well-being. This includes any serious or unstable general medical, psychiatric, or other conditions potentially jeopardizing safety, informed consent, or compliance.
• Any second malignancy within the previous 5 years, except for adequately treated cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma of the skin with limited growth, provided these are well controlled.
• Known regular use of illicit substances or recreational drugs, or a history of drug abuse or alcoholism within the past year.
• Plans to conceive during the study period, current pregnancy, or lactation.
• Known HIV-positive status.
• Known active hepatitis B or C infection.
• Evidence of active bleeding or hemorrhagic diathesis.
• Radiation therapy within 14 days prior to inclusion.
• Receipt of any anti-tumor treatments including:
• Surgery or tumor embolization within 14 days prior to the first OM-RCA-01 dose, or
• Chemotherapy, immunotherapy, biological therapy, investigational therapy, or endocrine therapy (except ongoing androgen deprivation therapy for prostate cancer) within 14 days or within two half-lives of the drug (whichever is longer) prior to the first OM-RCA-01 dose.
• Prior treatment with any FGFR-inhibiting or FGFR-blocking agents.