Actively Recruiting
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
Led by Kidney Cancer Research Bureau · Updated on 2026-01-21
58
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary efficacy of OM-RCA-01, a monoclonal antibody targeting fibroblast growth factor receptor 1 (FGFR1), in patients with metastatic solid tumors that express FGFR1. This Phase 1b/2, multicenter, open-label study uses a basket trial design enrolling patients regardless of tumor type, focusing on cancers such as renal cell carcinoma, non-small cell lung cancer, head and neck cancer, breast cancer, and prostate cancer. The study aims to understand the medical issues participants may experience, determine appropriate dosing for future studies, and assess whether tumor growth slows with treatment. All participants will receive OM-RCA-01 through an intravenous infusion every two weeks. Treatment will continue as long as the disease remains controlled and the drug is well tolerated. The study includes five tumor-specific groups and plans to enroll 58 patients. The drug is given at dose levels of 50 mg or 100 mg, and therapy will proceed until disease progression or unacceptable toxicity occurs. Participants will be monitored through regular assessments including imaging to measure tumor lesions, laboratory tests for organ function, and questionnaires to evaluate quality of life. Safety will be closely observed by tracking adverse events, serious side effects, and the presence of anti-drug antibodies. The study will follow patients for up to 12 months to evaluate outcomes such as progression-free survival, overall survival, and duration of response.
CONDITIONS
Brief 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 and dated informed consent confirming voluntary participation.
- Age 18 years or older at the time of consent.
- Body weight of at least 50 kg.
- Histologically confirmed metastatic solid tumors: clear-cell renal cell carcinoma, non-small cell lung cancer without EGFR or ALK mutations, castration-resistant prostate adenocarcinoma, specified breast adenocarcinoma, or head and neck squamous carcinoma or salivary gland cancer.
- Immunohistochemical expression of FGFR1 at 2+ or higher.
- Disease progression after at least two lines of standard therapy or lack of alternative treatments.
- At least one measurable lesion per 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.
- Life expectancy greater than 12 weeks.
- No psychological, social, or geographical obstacles to study participation.
- Women capable of childbearing must use effective contraception.
You will not qualify if you...
- Participation in another clinical trial or investigational treatment within 28 days before this study.
- Presence of central nervous system metastases or medullary carcinomatosis unless clinically stable for at least 1 month.
- Any serious or unstable medical, psychiatric, or other conditions that could affect safety or study completion.
- Any second malignancy within 5 years except certain well-controlled skin or cervical cancers.
- Recent history of illicit drug use or alcoholism within the past year.
- Pregnancy, lactation, or plans to conceive during the study.
- Known HIV-positive status.
- Active hepatitis B or C infection.
- Active bleeding or bleeding disorders.
- Recent radiation therapy within 14 days prior to inclusion.
- Recent surgery, chemotherapy, immunotherapy, or other anti-tumor treatments within specified time frames.
- Prior treatment with any FGFR-inhibiting or FGFR-blocking agents.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or unacceptable toxicity
Participants receive the monoclonal antibody OM-RCA-01, administered intravenously every 14 days, until disease progression or unacceptable toxicity.
Infusions every 14 days
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
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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