RecruitingPhase 1Phase 2NCT07292168

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

A Phase 1b/2 Study Evaluating the Safety and Preliminary Efficacy of OM-RCA-01, an Anti-FGFR1 Monoclonal Antibody, in Patients With Metastatic Cancers Expressing FGFR1.


Sponsor

Kidney Cancer Research Bureau

Enrollment

58 participants

Start Date

Dec 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new targeted antibody drug called OM-RCA-01 — which targets a protein called FGFR1 that is overexpressed on some tumor cells — alone or in combination with other therapies, in people with several types of advanced solid tumors. **You may be eligible if...** - You are 18 or older and weigh at least 50 kg - You have advanced metastatic cancer that is one of the following: clear-cell kidney cancer, non-small cell lung cancer (non-EGFR/ALK), castration-resistant prostate cancer, breast cancer, or head and neck squamous or salivary gland cancer - Your tumor has high (2+ or greater) expression of the protein FGFR1 on immunohistochemistry testing - Your cancer has progressed after at least two prior lines of standard treatment, or no good alternatives remain **You may NOT be eligible if...** - Your tumor does not express FGFR1 sufficiently - You have not yet tried available standard therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALhumanized monoclonal anti-FGFR1 antibody OM-RCA-01

OM-RCA-01, solution for infusion, 25 mg/mL; 50 mg (dose level 1) or 100 mg (dose level 2), intravenously, every 14 days


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

Republican Clinical Oncology Dispensary

Ufa, Russia

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NCT07292168


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