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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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.

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) is a Phase 1 / Phase 2 interventional studying Renal Cell Carcinoma Metastatic and Prostate Cancer Metastatic, sponsored by Kidney Cancer Research Bureau. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Renal Cell Carcinoma Metastatic, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 58 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Renal Cell Carcinoma Metastatic subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Signed and dated willing to sign a consent form Form confirming voluntary participation in the study. 2. Age ≥ 18 years at the time of consent. 3. Body weight ≥ 50 kg. 4. diagnosed by tissue sample (biopsy-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. You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1. 10. your organs (liver, kidneys, etc.) are working well enough based on blood tests, 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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

Locations (5)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07292168), the sponsor (Kidney Cancer Research Bureau), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07292168 clinical trial studying?

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.… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07292168?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07292168?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07292168. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07292168. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.