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 (TAGNOT)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer Metastatic; Prostate Cancer Metastatic; Renal Cell Carcinoma Metastatic; Breast Cancer Metastatic; Head & Neck Cancer
• Intervention / Treatment: Biological: humanized monoclonal anti-FGFR1 antibody OM-RCA-01

Detailed Description

FGFR1 is expressed on cells of various tumors, enabling their development. Currently, there are no reported monoclonal antibodies that block FGFR1, and only one chemically synthesized non-selective pan-FGFR inhibitor has been approved in the treatment of FGFR1-positive relapsed or refractory myeloid/lymphoid neoplasms.

OM-RCA-01 is an original innovative targeting drug focused on blocking FGFR1. OM-RCA-01 binds to the extracellular part of FGFR1. The main mechanism of action is blocking the activation processes of FGFR1. In studies, OM-RCA-01 was found to be a high-affinity and specific to FGFR1 antibody, inhibiting the phosphorylation of the receptor and the subsequent intracellular cascade. The amount of human protein in the structure of the humanized antibody is 92.9%.

The present clinical trial is a Phase 1b/2, multicenter, open-label, non-randomized, cohort study designed to evaluate the safety and preliminary efficacy of the monoclonal antibody OM-RCA-01 in patients with metastatic solid tumors expressing FGFR1.

This study adopts a basket trial design, enrolling patients based on the shared molecular characteristic of FGFR1 expression regardless of tumor histology. This approach enables the assessment of the anti-FGFR1 antibody's activity across multiple tumor types simultaneously.

Patients with FGFR1 expression meeting inclusion criteria (see the relevant section) will be enrolled into one of five tumor-specific cohorts:

• Renal cell carcinoma (RCC);
• Non-small cell lung cancer (NSCLC);
• Head and neck cancer (HNC);
• Breast cancer (BC);
• Prostate cancer (PCa) A total of 58 patients will be included. The study drug is administered intravenously, every 14 days till disease progression (RECIST 1.1) or unexaptable toxicity (CTCAE v.5.0).

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ilya Tsimafeyeu, MD, PhD; Phone Number: 9178914943; Email: sten_to@mail.ru

Study Locations

• Russia
  • Kazan', Russia
    • Active, not recruiting
    • Republican Dispensary of Tatarstan
  • Krasnoyarsk, Russia
    • Recruiting
    • A.I. Kryzhanovsky Krasnoyarsk Regional Cancer Center
    • Contact: Ruslan Zukov, Prof, MD, PhD; Phone Number: +7 (800) 355-0055; Email: priem@onkolog24.ru
  • Moscow, Russia
    • Recruiting
    • Hadassah Medical
    • Contact: Igor Utyashev, MD, PhD; Phone Number: +7 (495) 800 10 00; Email: i.utyashev@hadassah.moscow
    • Contact: Anna Bondyreva; Phone Number: +7 (495) 800 10 00; Email: a.bondareva@hadassah.moscow
  • Saint Petersburg, Russia
    • Recruiting
    • I.P. Pavlov First Saint Petersburg State Medical University
    • Contact: Svetlana Kutukova, MD, PhD; Phone Number: +7(812) 429-03-31; Email: sten_to@mail.ru
  • Ufa, Russia
    • Recruiting
    • Republican Clinical Oncology Dispensary
    • Contact: Alexander Sultanbaev, MD, PhD; Phone Number: +7 (347) 216-3671; Email: ufa.rkod@doctorrb.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed and dated Informed Consent Form confirming voluntary participation in the study.
2. Age ≥ 18 years at the time of consent.
3. Body weight ≥ 50 kg.

4. Histologically confirmed metastatic solid tumors:

   1. clear-cell renal cell carcinoma;
   2. non-small cell lung cancer (adenocarcinoma or squamous cell cancer without EGFR and ALK mutations);
   3. prostate cancer (castration-resistant adenocarcinoma);
   4. breast cancer (adenocarcinoma with specified status for estrogen receptors, progesterone receptors, HER2);
   5. head and neck tumors (squamous carcinoma, salivary gland cancer).
5. Immunohistochemical expression of FGFR1 of 2+ or higher.
6. Documented disease progression after at least two lines of standard therapy, or lack of available or feasible alternative standard treatment options for any reason.
7. Presence of at least one measurable lesion according to RECIST 1.1 criteria.
8. Availability of formalin-fixed and paraffin-embedded tumor tissue samples for biomarker analysis.
9. ECOG performance status 0 or 1.

10. Adequate organ function, confirmed by laboratory test results obtained within 7 days prior to Cycle 1 Day 1, meeting the following parameters:

    • Hemoglobin level ≥ 90 g/L
    • Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
    • Platelet count ≥ 100 × 10⁹/L
    • Serum creatinine level ≤ 1.5 × upper limit of normal (ULN)
    • Glomerular Filtration Rate (GFR) ≥ 30 mL/min
    • AST and ALT ≤ 3 × ULN (≤ 5 × ULN in patients with liver metastases)
    • Serum phosphorus within normal limits (≥ lower limit of normal and ≤ upper limit of normal)
    • Serum calcium ≥ lower limit of normal
    • Serum potassium ≥ lower limit of normal (note: use of medications to increase potassium during screening is permitted)
11. Life expectancy of more than 12 weeks.
12. Absence of any psychological, familial, social or geographical circumstances that could potentially serve as an obstacle to the fulfillment of the study protocol and follow-up procedures according to the prescribed schedule and the ability of the study participant to follow the requirements of the protocol; these circumstances should be discussed with the patient before inclusion in the study.
13. Women capable of childbearing must be using an effective method of contraception.

Exclusion Criteria:

1. 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.

2. Presence of central nervous system (CNS) metastases and/or medullary carcinomatosis at the time of inclusion.

   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

3. 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.
4. 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.
5. Known regular use of illicit substances or recreational drugs, or a history of drug abuse or alcoholism within the past year.
6. Plans to conceive during the study period, current pregnancy, or lactation.
7. Known HIV-positive status.
8. Known active hepatitis B or C infection.
9. Evidence of active bleeding or hemorrhagic diathesis.
10. Radiation therapy within 14 days prior to inclusion.

11. Receipt of any anti-tumor treatments including:

    • Surgery or tumor embolization within 14 days prior to the first OM-RCA-01 dose, or
    • Chemotherapy, immunotherapy, biological therapy, investigational therapy, or endocrine therapy (except ongoing androgen deprivation therapy for prostate cancer) within 14 days or within two half-lives of the drug (whichever is longer) prior to the first OM-RCA-01 dose.
12. Prior treatment with any FGFR-inhibiting or FGFR-blocking agents.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; OM-RCA-01	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median progression-free survival		12 months
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
12-month progression-free survival rate		12 months
Median overall survival		12 months
12-month overall survival rate		12 months
Median duration of response		12 months
Quality of life, assessed using the EORTC QLQ-C30 questionnaire	in patients before and after 8 weeks of therapy (0-100)	8 weeks
Concentration of anti-drug antibodies	Assessment of immunogenicity	12 months
Pharmacokinetics profile: Cmax	the highest concentration of OM-RCA-01 in the blood	1 month
Pharmacokinetics profile: Tmax	The time it takes for a antibody to reach the maximum concentration	1 month
Pharmacokinetics profile: AUC0-t	the area under the plasma concentration-time curve from time zero to time t	1 month
Pharmacokinetics profile: CL	clearance	1 month
Pharmacokinetics profile: T1/2	the time required for plasma concentration of a OM-RCA-01 to decrease by 50%	1 month
Pharmacokinetics profile: Vss	Steady-state volume of distribution	1 month
Pharmacokinetics profile: Kel	the elimination rate constant	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	12 months
Assessment of Biomarkers: cfDNA	cfDNA level in plasma	12 months
Assessment of Biomarkers: sFlt-1	sFlt-1 in plasma	12 months

Collaborators and Investigators

• Sponsor: Kidney Cancer Research Bureau

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; lung cancer; prostate cancer; monoclonal antibody; kidney cancer; metastatic cancer; resistance; head & neck cancer; fibroblast growth factor receptor 1; OM-RCA-01
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Skin Diseases; Breast Diseases; Urologic Neoplasms; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Bone Diseases, Developmental; Limb Deformities, Congenital; Synostosis; Dysostoses; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Craniosynostoses; Syndactyly; Prostatic Neoplasms; Lung Neoplasms; Breast Neoplasms; Neoplasm Metastasis; Head and Neck Neoplasms; Kidney Neoplasms; Acrocephalosyndactylia
• Other Study ID Numbers: OMRCA01-TAGNOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No