Renal Cell Carcinoma MetastaticPhase 1/2TAGNOTNCT07292168
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 1/2 study testing humanized monoclonal anti-FGFR1 antibody OM-RCA-01 in people with Renal Cell Carcinoma Metastatic and Prostate Cancer Metastatic, run by Kidney Cancer Research Bureau at 5 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma Metastatic, Prostate Cancer Metastatic, Non-small Cell Lung Cancer Metastatic
- What is being tested?
- humanized monoclonal anti-FGFR1 antibody OM-RCA-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 5 sitesRussia
- Study dates
- 2 Dec 2025to 1 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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:
- 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)
- Life expectancy of more than 12 weeks.
- 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.
- Women capable of childbearing must be using an effective method of contraception.
Who cannot join
- 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.
- 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
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- 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.
- Radiation therapy within 14 days prior to inclusion.
- 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.
- Prior treatment with any FGFR-inhibiting or FGFR-blocking agents.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Russia5 sites, 4 recruiting
- Active, not recruiting
Republican Dispensary of Tatarstan
Kazan'
- Recruiting
A.I. Kryzhanovsky Krasnoyarsk Regional Cancer Center
Krasnoyarsk
Ruslan Zukov, Prof, MD, PhD, +7 (800) 355-0055, priem@onkolog24.ru
- Recruiting
Hadassah Medical
Moscow
Igor Utyashev, MD, PhD, +7 (495) 800 10 00, i.utyashev@hadassah.moscow
Anna Bondyreva, +7 (495) 800 10 00, a.bondareva@hadassah.moscow
- Recruiting
I.P. Pavlov First Saint Petersburg State Medical University
Saint Petersburg
Svetlana Kutukova, MD, PhD, +7(812) 429-03-31, sten_to@mail.ru
- Recruiting
Republican Clinical Oncology Dispensary
Ufa
Alexander Sultanbaev, MD, PhD, +7 (347) 216-3671, ufa.rkod@doctorrb.ru
About this study
Official title: 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:
Read more
- What medical problems do participants have when receiving drug OM-RCA-01?
- What dose of the drug should patients receive in the next studies?
- 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.
Read the 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).
- Conditions
- Renal Cell Carcinoma Metastatic, Prostate Cancer Metastatic, Non-small Cell Lung Cancer Metastatic, Breast Cancer Metastatic, Head & Neck Cancer
- Being tested
- humanized monoclonal anti-FGFR1 antibody OM-RCA-01
- 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
- Medical subject headings
- Head and Neck Neoplasms, Neoplasm Metastasis, Acrocephalosyndactylia, Kidney Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
humanized monoclonal anti-FGFR1 antibody OM-RCA-01Biological
OM-RCA-01, solution for infusion, 25 mg/mL; 50 mg (dose level 1) or 100 mg (dose level 2), intravenously, every 14 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | OM-RCA-01 Receives: Biological: humanized monoclonal anti-FGFR1 antibody OM-RCA-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint in the phase 1b study
Recommended Phase 2 Dose (RP2D)
Measured: 6 months
Primary endpoint in the phase 2 study
Objective response rate according to RECIST 1.1 criteria as assessed by the investigator
Measured: 12 months
Secondary outcomes (16)
Number of Participants with Treatment-Related Adverse Events (AEs) as Assessed by CTCAE v5.0
Measured: 12 months
Number of Participants with serious AEs
Measured: 12 months
Median progression-free survival
Measured: 12 months
12-month progression-free survival rate
Measured: 12 months
Median overall survival
Measured: 12 months
12-month overall survival rate
Measured: 12 months
Median duration of response
Measured: 12 months
Quality of life, assessed using the EORTC QLQ-C30 questionnaire
in patients before and after 8 weeks of therapy (0-100)
Measured: 8 weeks
Concentration of anti-drug antibodies
Assessment of immunogenicity
Measured: 12 months
Pharmacokinetics profile: Cmax
the highest concentration of OM-RCA-01 in the blood
Measured: 1 month
Pharmacokinetics profile: Tmax
The time it takes for a antibody to reach the maximum concentration
Measured: 1 month
Pharmacokinetics profile: AUC0-t
the area under the plasma concentration-time curve from time zero to time t
Measured: 1 month
Pharmacokinetics profile: CL
clearance
Measured: 1 month
Pharmacokinetics profile: T1/2
the time required for plasma concentration of a OM-RCA-01 to decrease by 50%
Measured: 1 month
Pharmacokinetics profile: Vss
Steady-state volume of distribution
Measured: 1 month
Pharmacokinetics profile: Kel
the elimination rate constant
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start2 Dec 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kidney Cancer Research Bureau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292168
- Sponsor's protocol ID
- OMRCA01-TAGNOT
- Acronym
- TAGNOT
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07292168
- Acronym / sponsor ID
- TAGNOT / OMRCA01-TAGNOT
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Kidney Cancer Research BureauUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What medical problems do participants have when receiving drug OM-RCA-01?
- What dose of the drug should patients receive in the next studies?
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: humanized monoclonal anti-FGFR1 antibody OM-RCA-01OM-RCA-01 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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:
- Immunohistochemical expression of FGFR1 of 2+ or higher.
Key exclusion criteria (21 listed)
- 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.
- 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:
- History of or current evidence of any condition, therapy, or laboratory abnormality that could:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| humanized monoclonal anti-FGFR1 antibody OM-RCA-01OM-RCA-01, solution for infusion, 25 mg/mL; 50 mg (dose level 1) or 100 mg (dose level 2), intravenously, every 14 days | Biological | Treatment |
Primary outcome
Primary endpoint in the phase 1b study
Time frame: 6 months
Recommended Phase 2 Dose (RP2D)
Primary endpoint in the phase 2 study
Time frame: 12 months
Objective response rate according to RECIST 1.1 criteria as assessed by the investigator
16 secondary outcomes
Number of Participants with Treatment-Related Adverse Events (AEs) as Assessed by CTCAE v5.0
Time frame: 12 months
Number of Participants with serious AEs
Time frame: 12 months
Median progression-free survival
Time frame: 12 months
12-month progression-free survival rate
Time frame: 12 months
Median overall survival
Time frame: 12 months
12-month overall survival rate
Time frame: 12 months
Median duration of response
Time frame: 12 months
Quality of life, assessed using the EORTC QLQ-C30 questionnaire
Time frame: 8 weeks
Concentration of anti-drug antibodies
Time frame: 12 months
Pharmacokinetics profile: Cmax
Time frame: 1 month
Pharmacokinetics profile: Tmax
Time frame: 1 month
Pharmacokinetics profile: AUC0-t
Time frame: 1 month
Pharmacokinetics profile: CL
Time frame: 1 month
Pharmacokinetics profile: T1/2
Time frame: 1 month
Pharmacokinetics profile: Vss
Time frame: 1 month
Pharmacokinetics profile: Kel
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing humanized monoclonal anti-FGFR1 antibody OM-RCA-01 in people with Renal Cell Carcinoma Metastatic and Prostate Cancer Metastatic, run by Kidney Cancer Research Bureau at 5 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilya Tsimafeyeu, MD, PhD (9178914943, sten_to@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint in the phase 1b study (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.