OncoMatch/Clinical Trials/NCT07292168
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
Is NCT07292168 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies humanized monoclonal anti-FGFR1 antibody OM-RCA-01 for renal cell carcinoma metastatic.
Treatment: humanized monoclonal anti-FGFR1 antibody OM-RCA-01 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Prostate Cancer
Non-Small Cell Lung Carcinoma
Breast Carcinoma
Biomarker criteria
Required: FGFR1 immunohistochemical expression of 2+ or higher (2+ or higher)
Immunohistochemical expression of FGFR1 of 2+ or higher
Required: EGFR wild-type
non-small cell lung cancer (adenocarcinoma or squamous cell cancer without EGFR and ALK mutations)
Required: ALK wild-type
non-small cell lung cancer (adenocarcinoma or squamous cell cancer without EGFR and ALK mutations)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: fgfr inhibitor
Lab requirements
Blood counts
Hemoglobin level ≥ 90 g/L; ANC ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L
Kidney function
Serum creatinine level ≤ 1.5 × ULN; GFR ≥ 30 mL/min
Liver function
AST and ALT ≤ 3 × ULN (≤ 5 × ULN in patients with liver metastases)
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; ANC ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Serum creatinine level ≤ 1.5 × ULN; GFR ≥ 30 mL/min; AST and ALT ≤ 3 × ULN (≤ 5 × ULN in patients with liver metastases); Serum phosphorus within normal limits; Serum calcium ≥ lower limit of normal; Serum potassium ≥ lower limit of normal (note: use of medications to increase potassium during screening is permitted)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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