Actively Recruiting
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
Led by Kidney Cancer Research Bureau · Updated on 2026-01-21
58
Participants Needed
5
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Age 18 years or older.
- Body weight of at least 50 kg.
- Histologically confirmed metastatic solid tumors including clear-cell renal cell carcinoma, non-small cell lung cancer (adenocarcinoma or squamous cell without EGFR and ALK mutations), castration-resistant prostate adenocarcinoma, breast adenocarcinoma with specified hormone receptor status, or head and neck squamous carcinoma or salivary gland cancer.
- FGFR1 expression level of 2+ or higher by immunohistochemistry.
- Disease progression after at least two lines of standard therapy or no available standard treatment.
- At least one measurable tumor lesion by RECIST 1.1 criteria.
- Availability of tumor tissue samples for biomarker analysis.
- ECOG performance status of 0 or 1.
- Adequate organ function based on recent laboratory tests including hemoglobin ≥ 90 g/L, neutrophils ≥ 1.5 x10^9/L, platelets ≥ 100 x10^9/L, creatinine ≤ 1.5 times normal, GFR ≥ 30 mL/min, liver enzymes ≤ 3 times normal (≤ 5 times if liver metastases), normal serum phosphorus, calcium, and potassium levels.
- Life expectancy longer than 12 weeks.
- No psychological, social, or geographical barriers to study participation.
- Women of childbearing potential must use effective contraception.
You will not qualify if you...
- Participation in another clinical trial or use of investigational anticancer therapy within 28 days before this study.
- Presence of central nervous system metastases or carcinomatosis unless clinically stable for at least 1 month without steroids and able to consent.
- Any serious or unstable medical, psychiatric, or other conditions that could affect safety or study completion.
- Second cancer within the last 5 years except certain well-controlled skin or cervical cancers.
- Current drug abuse or alcoholism within the past year.
- Pregnancy, lactation, or plans to conceive during the study.
- Known HIV infection.
- Active hepatitis B or C infection.
- Active bleeding or bleeding disorders.
- Radiation therapy within 14 days before study start.
- Surgery, tumor embolization, chemotherapy, immunotherapy, biological therapy, investigational therapy, or endocrine therapy within 14 days or drug half-lives before first dose (except ongoing androgen deprivation for prostate cancer).
- Prior treatment with any FGFR-inhibiting or FGFR-blocking agents.
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Republican Dispensary of Tatarstan
Kazan', Russia
Active, Not Recruiting
2
A.I. Kryzhanovsky Krasnoyarsk Regional Cancer Center
Krasnoyarsk, Russia
Actively Recruiting
3
Hadassah Medical
Moscow, Russia
Actively Recruiting
4
I.P. Pavlov First Saint Petersburg State Medical University
Saint Petersburg, Russia
Actively Recruiting
5
Republican Clinical Oncology Dispensary
Ufa, Russia
Actively Recruiting
Research Team
I
Ilya Tsimafeyeu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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