A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients Wi… (NCT07292168) | Clinical Trial Compass
RecruitingPhase 1/2
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
Russia58 participantsStarted 2025-12-02
Plain-language 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.
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed and dated Informed Consent Form confirming voluntary participation in the study.
✓. non-small cell lung cancer (adenocarcinoma or squamous cell cancer without EGFR and ALK mutations);
✓. prostate cancer (castration-resistant adenocarcinoma);
✓. breast cancer (adenocarcinoma with specified status for estrogen receptors, progesterone receptors, HER2);
Exclusion criteria
✕. 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.
✕. 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.
✕. 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.