Krasnoyarsk

Researchers are studying metastatic cancers that express the fibroblast growth factor receptor 1 (FGFR1), focusing on a new targeted treatment using a monoclonal antibody called OM-RCA-01. This Phase 1b/2 clinical trial aims to evaluate how well OM-RCA-01 works and its safety in patients with various types of metastatic tumors such as renal cell carcinoma, non-small cell lung cancer, head and neck cancer, breast cancer, and prostate cancer. The study will help determine the appropriate dosage and observe any medical issues during treatment, while also assessing if the tumor growth slows. All participants will receive the OM-RCA-01 antibody intravenously every two weeks. The antibody works by blocking the activation of FGFR1, which is involved in tumor development. Patients will continue to receive the treatment as long as the disease does not progress and the drug is tolerated. The study uses a basket design enrolling patients based on FGFR1 expression regardless of tumor type, and will include up to 58 patients divided into five tumor-specific groups. During the study, participants will undergo various assessments including tumor evaluations according to RECIST 1.1 criteria, laboratory tests to monitor organ function, and biomarker analysis from tumor tissue samples. Safety and efficacy will be observed over six months for Phase 1b and twelve months for Phase 2. Researchers will monitor for treatment side effects, tumor response, and patient health throughout the trial to gather comprehensive information on the study drug's impact.

Researchers are evaluating the effectiveness and safety of two drugs, BCD-264 and Darzalex, as single treatments for people with relapsed and refractory multiple myeloma. This study focuses on patients who have previously been treated with proteasome inhibitors and immunomodulatory drugs but whose disease progressed after prior therapy. The goal is to compare how well each drug works and how safe they are for these patients. Participants receive either BCD-264 or Darzalex through intravenous infusion at a dose of 16 mg/kg. Both treatments are given as monotherapy, meaning each drug is used alone without combining with other therapies. The study is designed as a double-blind, randomized clinical trial, which means neither the participants nor the researchers know who receives which drug during the trial. During the study, researchers monitor participants for up to 24 weeks to measure the overall response rate using the International Myeloma Working Group criteria. Participants will have regular assessments to track their disease status and treatment safety. Safety and efficacy data are collected throughout the study to evaluate and compare the two treatments' profiles in this patient population.

Researchers are evaluating the safety and effectiveness of increasing doses of IPN10200 to understand its pharmacodynamics and identify the best dose for treating adults with upper limb spasticity. This integrated Phase I/II, multicenter, double-blind, randomized study also compares IPN10200 with Dysport and placebo to find the optimal balance of efficacy and safety in adults aged 18 to 70 years with spastic hemiparesis following stroke or traumatic brain injury. Participants receive either IPN10200, Dysport, or placebo as a powder and solvent solution for injection. The study includes dose escalation and dose-finding phases to assess different dosing levels. Treatments are administered in the affected upper limb muscles, with eligibility based on specific muscle tone and spasticity angle criteria. The study monitors participants for up to 9 months, including a safety follow-up period. During the study, participants undergo regular assessments including vital signs (blood pressure and heart rate), clinical lab tests, physical examinations, and monitoring for treatment-emergent adverse events and antibodies to the study drugs. Researchers use these measures to evaluate safety and treatment effects over the 9-month period from baseline through the end of the study.

Researchers are evaluating the effects of a combined treatment of zibotentan and dapagliflozin compared to dapagliflozin alone in adults with chronic kidney disease (CKD) who have high levels of protein in their urine. This Phase II, multicenter, randomized, double-blind study aims to assess the efficacy, safety, and tolerability of this combination on top of standard care, including participants with or without type 2 diabetes mellitus (T2DM). The study will provide important clinical data for potential approval of this combination treatment in the Eurasian Economic Union. Participants may undergo a 28-day run-in period with dapagliflozin if they are not already using SGLT2 inhibitors at screening. Following this, they will enter a 12-week double-blind treatment period where they receive either the fixed-dose combination of zibotentan/dapagliflozin or dapagliflozin monotherapy once daily. After completing the treatment phase, all participants will receive open-label dapagliflozin alone during a 4-week safety follow-up period. Throughout the study, researchers will monitor changes in urinary albumin to creatinine ratio (UACR) from baseline at week 12 to evaluate treatment effects. Participants will be assessed regularly for safety, tolerability, and efficacy, with clinical evaluations including laboratory tests and monitoring of adverse events. The total study participation includes the run-in period, 12-week treatment, and a 4-week safety follow-up, ensuring comprehensive observation of treatment impact and participant health.

This research investigates treatment patterns and the evaluation of homologous recombination repair mutations (HRRm) in circulating tumor DNA (ctDNA) among patients with aggressive high-volume metastatic hormone-sensitive prostate cancer (mHSPC) in the Russian Federation. The study focuses on patients with high-aggressive disease characterized by Gleason scores 8-10 and high-volume disease as defined by specific criteria for bone and visceral metastases. Approximately 400 male patients aged 18 years and older with known tumor HRRm status will participate to better understand demographic and clinical characteristics and treatment approaches in routine practice. The study does not introduce new treatments but observes and collects data as patients receive standard care. Two study visits will occur: the first at baseline to gather medical history, demographic data, and treatment information from diagnosis to enrollment, including routine blood samples for ctDNA and HRRm testing. The second visit will happen at disease progression or after about 12 months to collect follow-up data on progression to metastatic castration-resistant prostate cancer (mCRPC) and subsequent treatments. Blood samples will be analyzed centrally. Participants will have their medical records reviewed and may be interviewed to complete missing information. Data will be entered into electronic records by the study physician. Outcome measures include the proportion of patients receiving various treatments (such as androgen deprivation therapy, chemotherapy, radiation, surgery, and specific inhibitors), duration of therapies, time to progression, mutation presence in ctDNA, testosterone levels, and sites of disease progression over 36 months. Follow-up may be completed by phone if in-person visits are not possible, with the total study duration lasting about 38 months or until data from 400 patients are collected.

Researchers are evaluating the physical impact of multiple sclerosis (MS) from the participant's perspective while providing continued access to the drug ocrelizumab. This Phase 3 extension study focuses on assessing the safety and tolerability of ocrelizumab, a treatment for MS, at approved doses. The study includes participants who were already receiving ocrelizumab in previous Genentech and/or F. Hoffmann-La Roche Ltd sponsored studies and do not have local access to this treatment through other means. Participants will receive ocrelizumab either by intravenous (IV) infusion at 600 milligrams or by subcutaneous (SC) injection at 920 milligrams, following the dosing schedule from their previous parent study. Treatment will begin no earlier than five months after their last dose in the parent study. This open-label, multicenter extension provides ongoing access to ocrelizumab for up to five years. Throughout the study, participants will be monitored for changes in their physical functioning using the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure for Multiple Sclerosis (PROMISnq PFMS-15a). Researchers will also track the number of participants receiving ocrelizumab during the study and assess safety and tolerability over the long term. Monitoring includes regular evaluations to ensure participant well-being during the extended treatment period.

Researchers are conducting a national, multicenter, prospective study in the Russian Federation to collect real-world data on patients with aggressive, advanced endometrial cancer (stages III-IV). The study aims to understand the prevalence of molecular markers such as POLE mutations, dMMR/pMMR, p53 abnormalities, HER2, and PD-L1, as well as to observe first-line postoperative treatment approaches in these patients. Approximately 500 female patients with newly diagnosed aggressive subtypes of advanced endometrial cancer will be enrolled across about 30 sites. The study involves two visits aligned with routine clinical practice. At the first visit, demographic and clinical information will be collected from medical records or patient interviews, along with biopsy or archival tumor samples for molecular testing using immunohistochemistry and genetic sequencing methods. The second visit occurs six months after baseline or at disease progression, whichever is earlier, to gather follow-up data on treatments and disease status. No additional procedures beyond standard care are applied. Participants' data will be securely entered into electronic case report forms by study physicians. Researchers will monitor the rates of molecular markers such as POLE mutation positivity, mismatch repair status, p53 abnormalities, PD-L1 expression, and HER2 expression over 24 months. The overall study duration, from first patient enrollment to final data analysis, is expected to be about 27 months or until all data from 500 patients are collected, including follow-up information.

Researchers are evaluating the effectiveness and safety of BCD-248 as a treatment for patients with relapsed or refractory multiple myeloma. This open-label Phase 2 study focuses on individuals who have previously received at least two lines of therapy, including specific treatments like proteasome inhibitors, immunomodulatory drugs, and anti-CD38 therapy. Participants must have measurable disease and documented progression according to established criteria. The study treatment involves administering BCD-248 subcutaneously. Patients eligible for the trial will receive this investigational drug during the study period. There are no comparator groups mentioned, and the treatment is given as a single intervention. This trial does not mention additional phases or extension periods. Participants will be monitored for their overall response rate to treatment up to 24 weeks, based on criteria set by the International Myeloma Working Group. Assessments include disease evaluations and safety monitoring. The study involves careful screening to ensure participants meet specific health and prior treatment requirements, with follow-up to track treatment outcomes and adverse events throughout the study duration.

This research aims to understand the clinical and demographic characteristics of adult patients living with Neurofibromatosis type 1 (NF1) in Russia. It is an open-label, single-arm, non-interventional, multi-center cohort study focused on evaluating clinical outcomes and patient-reported experiences in routine care settings. The study includes adults diagnosed with NF1 who have plexiform neurofibromas (PN) confirmed by clinical or imaging methods and who experience symptoms related to PN. The study does not involve any investigational treatments or interventions but observes patients during their routine care. It enrolls adults aged 18 years or older with newly diagnosed PN or established PN who have not been treated with MEK inhibitors for PN. Diagnosis confirmation includes clinical assessment, ultrasound imaging, MRI, or biopsy. Patients with certain cancers requiring chemotherapy or radiation, or those who have recently used MEK inhibitors, are excluded. Participants will undergo a variety of assessments at the start of the study, including measurement of age, body metrics, educational background, NF1 complications, and symptoms related to PN. Researchers will review medical histories, hospitalizations, disability status, and prior examinations. The study collects data on PN volume and duration of symptoms and diagnosis. Follow-up visits and further evaluations will be conducted as per routine care. The study monitors changes in disability and overall health status during participation.

Researchers are conducting an observational multicenter cross-sectional study to better understand the characteristics of adults with uncontrolled severe asthma in Russia who are not receiving biological therapy. The study aims to collect detailed information on the epidemiology, clinical features, treatment patterns, and demographics of these patients across different regions of the Russian Federation, which vary widely in population composition and environmental factors. The study will help fill the gap in data about severe asthma in Russia, especially in patients treated according to standard care but excluding biologics. The study plans to include 5,000 adult patients from about 50 outpatient centers across 50 regions of Russia. It will collect routine clinical data without altering standard medical care or introducing any new diagnostic or therapeutic procedures. The study design includes one visit per patient to gather demographic, clinical, and treatment information, focusing on patients with uncontrolled severe asthma receiving standard treatments like inhaled corticosteroids with other medications but not biological agents. Participants will provide data through medical records and assessments such as the Asthma Control Questionnaire. Researchers will analyze patterns of drug use, clinical characteristics including comorbidities, blood counts, immunoglobulin levels, and lifestyle factors. The study will characterize patients' demographics, treatment trends, and asthma control status from June 2024 to June 2027. Safety monitoring is observational, with no intervention beyond routine care, and the total participation involves a single study visit.