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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

NCT07292168 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Renal Cell Carcinoma Metastatic
  • Prostate Cancer Metastatic
  • Non-small Cell Lung Cancer Metastatic
  • Breast Cancer Metastatic
  • Head & Neck Cancer

Interventions

BIOLOGICAL

humanized 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

Sponsors & Collaborators

  • Kidney Cancer Research Bureau

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-02
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07292168 on ClinicalTrials.gov