One of the most relevant targets in the field of novel targeted anticancer therapy is the family of receptors to fibroblast growth factor receptors (FGFRs). FGFR1 is the main representative of the FGFR family.
The goal of this clinical trial is to learn if monoclonal anti-FGFR1 antibody (OM-RCA-01) works to treat metastatic cancers expressing FGFR1. It will also learn about the safety of drug OM-RCA-01. The main questions it aims to answer are:
1. What medical problems do participants have when receiving drug OM-RCA-01? 2. What dose of the drug should patients receive in the next studies? 3. Does tumor growth slow down in patients receiving OM-RCA-01?
All patients in this study will receive the antibody treatment. The drug will be given through a vein (by IV infusion) every two weeks, for as long as the disease remains under control and the treatment is well tolerated.
Signed and dated Informed Consent Form confirming voluntary participation in the study.
Age ≥ 18 years at the time of consent.
Body weight ≥ 50 kg.
clear-cell renal cell carcinoma;
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.
No evidence of new or progressive CNS metastases
No ongoing steroid therapy
Single group
humanized monoclonal anti-FGFR1 antibody OM-RCA-01
Biological/VaccineOM-RCA-01, solution for infusion, 25 mg/mL; 50 mg (dose level 1) or 100 mg (dose level 2), intravenously, every 14 days
Primary endpoint in the phase 1b study
Recommended Phase 2 Dose (RP2D)
Primary endpoint in the phase 2 study
Objective response rate according to RECIST 1.1 criteria as assessed by the investigator
Number of Participants with Treatment-Related Adverse Events (AEs) as Assessed by CTCAE v5.0
Number of Participants with serious AEs
Median progression-free survival
12-month progression-free survival rate
Analysis of objective response rate, progression-free survival and overall survival based on FGFR1 expression level
FGFR1 immunohistochemical expression (IHC) 3+ versus IHC 2+ in tumors;
Assessment of Biomarkers: cfDNA
cfDNA level in plasma
Assessment of Biomarkers: sFlt-1
sFlt-1 in plasma
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