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Tests treatment safety and results for Renal Cell Carcinoma Metastatic
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
ClinicalTrials.gov ID: NCT07292168
What this study is testing
What is humanized monoclonal anti-FGFR1 antibody OM-RCA-01?
humanized monoclonal anti-FGFR1 antibody OM-RCA-01 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for renal cell carcinoma metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed and dated Informed Consent Form confirming voluntary participation in the study.
- Age ≥ 18 years at the time of consent.
- Body weight ≥ 50 kg.
- Histologically confirmed metastatic solid tumors:
- clear-cell renal cell carcinoma;
You likely can't join if
- Participation in another clinical trial or concomitant treatment with any investigational drug, or administration of any investigational anticancer...
- Presence of central nervous system (CNS) metastases and/or medullary carcinomatosis at the time of inclusion. Exception: Patients with CNS metastases...
- No evidence of new or progressive CNS metastases
- No ongoing steroid therapy
- Stable mental status sufficient to provide informed consent
- History of or current evidence of any condition, therapy, or laboratory abnormality that could:
See the full eligibility criteria
- Signed and dated Informed Consent Form confirming voluntary participation in the study.
- Age ≥ 18 years at the time of consent.
- Body weight ≥ 50 kg.
- Histologically confirmed metastatic solid tumors:
- clear-cell renal cell carcinoma;
- 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);
- head and neck tumors (squamous carcinoma, salivary gland cancer).
- Immunohistochemical expression of FGFR1 of 2+ or higher.
- Documented disease progression after at least two lines of standard therapy, or lack of available or feasible alternative standard treatment options for any reason.
- Presence of at least one measurable lesion according to RECIST 1.1 criteria.
- Availability of formalin-fixed and paraffin-embedded tumor tissue samples for biomarker analysis.
- ECOG performance status 0 or 1.
- 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)
- Life expectancy of more than 12 weeks.
- 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...
- Women capable of childbearing must be using an effective method of contraception.
- 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. Exception: Patients with CNS metastases who have received therapy may participate if they have been...
- No evidence of new or progressive CNS metastases
- No ongoing steroid therapy
- Stable mental status sufficient to provide informed consent
- 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.
- 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...
- 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.
- Known HIV-positive status.
- Known active hepatitis B or C infection.
- Evidence of active bleeding or hemorrhagic diathesis.
- Radiation therapy within 14 days prior to inclusion.
- 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...
- Prior treatment with any FGFR-inhibiting or FGFR-blocking agents.
The study team makes the final eligibility decision.
Where it's taking place
- Kazan', Russia
- Krasnoyarsk, Russia
- Moscow, Russia
- Saint Petersburg, Russia
- Ufa, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kazan', Russia; Krasnoyarsk, Russia; Moscow, Russia; Saint Petersburg, Russia; Ufa, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.