About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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

Trial design

Treatments tested in this trial

  • humanized monoclonal anti-FGFR1 antibody OM-RCA-01

Treatment groups

58 Participants
are divided into 1 treatment group

Locations

5
Republican Dispensary of Tatarstan Kazan' Russia
A.I. Kryzhanovsky Krasnoyarsk Regional Cancer Center Krasnoyarsk Russia
Hadassah Medical Moscow Russia
I.P. Pavlov First Saint Petersburg State Medical University Saint Petersburg Russia

Sponsors and collaborators

Kidney Cancer Research Bureau

Lead sponsor