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 | Recruiting Phase 1 DMC

• 1 other identifier: OMRCA01-TAGNOT
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 5

Brief 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. 1.What medical problems do participants have when receiving drug OM-RCA-01?
2. 2.What dose of the drug should patients receive in the next studies?
3. 3.Does tumor growth slow down in patients receiving OM-RCA-01?

Conditions

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

Keywords

metastatic cancer; resistance; monoclonal antibody; fibroblast growth factor receptor 1; OM-RCA-01; kidney cancer; prostate cancer; head & neck cancer; lung cancer; breast cancer

Outcome Measures

Primary Outcomes (2)

• Primary endpoint in the phase 1b study

  Recommended Phase 2 Dose (RP2D)

  6 months

• Primary endpoint in the phase 2 study

  Objective response rate according to RECIST 1.1 criteria as assessed by the investigator

  12 months

Secondary Outcomes (16)

• Number of Participants with Treatment-Related Adverse Events (AEs) as Assessed by CTCAE v5.0

  12 months

• Number of Participants with serious AEs

  12 months

• Median progression-free survival

  12 months

• 12-month progression-free survival rate

  12 months

• Median overall survival

  12 months

Other Outcomes (3)

• Analysis of objective response rate, progression-free survival and overall survival based on FGFR1 expression level

  12 months

• Assessment of Biomarkers: cfDNA

  12 months

• Assessment of Biomarkers: sFlt-1

  12 months

Study Arms (1)

Treatment

EXPERIMENTAL

OM-RCA-01

Biological: humanized monoclonal anti-FGFR1 antibody OM-RCA-01

Interventions

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

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.
• Receipt of any anti-tumor treatments including:

Sponsors & Collaborators

• Kidney Cancer Research Bureau: lead

Study Sites (5)

Republican Dispensary of Tatarstan

Kazan', Russia

ACTIVE NOT RECRUITING

A.I. Kryzhanovsky Krasnoyarsk Regional Cancer Center

Krasnoyarsk, Russia

RECRUITING

Hadassah Medical

Moscow, Russia

RECRUITING

I.P. Pavlov First Saint Petersburg State Medical University

Saint Petersburg, Russia

RECRUITING

Republican Clinical Oncology Dispensary

Ufa, Russia

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasm Metastasis; Acrocephalosyndactylia; Kidney Neoplasms; Prostatic Neoplasms; Lung Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Craniosynostoses; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Syndactyly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ilya Tsimafeyeu, MD, PhD

CONTACT

9178914943; sten_to@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 18, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

RU (5)