Krasnoyarsk

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 1b2, 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.

Researchers are evaluating the safety and effectiveness of BCD-248 combined with daratumumab compared to a combination of daratumumab, pomalidomide, and dexamethasone for treating adults with relapsed or refractory multiple myeloma. This study focuses on participants aged 18 and older who have measurable multiple myeloma and have received previous treatments including a proteasome inhibitor and lenalidomide, specifically those who are refractory to lenalidomide or have had disease progression after prior therapies. Participants will receive either BCD-248 administered under the skin with daratumumab given intravenously, or the combination of daratumumab intravenously with pomalidomide and dexamethasone taken orally. The study is randomized without masking, comparing these two treatment groups in parallel. The intervention period includes monitoring for up to 36 months to assess disease progression and response, with additional long-term evaluations lasting up to 5 years. During the trial, participants will undergo assessments including measuring minimal residual disease using flow cytometry at 12 months, and monitoring progression-free survival per established criteria. Other evaluations include response rates, survival, immune markers, and adverse events over several years. Safety and treatment effects will be closely followed with regular clinical visits and laboratory tests throughout the study duration, which extends until October 2032.

Researchers are evaluating the safety and effectiveness of different doses of Corabotase also called IPN10200 for treating adults with upper limb spasticity. This study aims to understand how Corabotase affects the body and to determine which doses provide the best balance of safety and benefit. The trial involves adult participants aged 18 to 70 years who have spastic hemiparesis following stroke or traumatic brain injury and meet other specific health criteria. The study includes several groups receiving different doses of Corabotase, Dysport, or placebo as single injections into various upper limb muscles. Participants are assigned randomly to groups, with some in dose-escalation cohorts and others in fixed-dose groups. The injections are given once, and doses are carefully adjusted to assess safety and response. The trial uses a double-blind design, meaning neither participants nor researchers know who receives which treatment. Participants will be monitored over nine months with regular assessments including physical exams, vital signs, lab tests, and evaluations of muscle spasticity using the Modified Ashworth Scale. Researchers will track any side effects, antibody development, and changes in muscle tone and disability. Patient and physician impressions of treatment effects and pain levels will also be recorded. This long-term follow-up helps researchers understand how the treatments work and their safety over time.

Researchers are studying adult participants with chronic kidney disease CKD who have high protein levels in their urine. The study aims to evaluate the effects of a combination of two drugs, zibotentan and dapagliflozin, compared to dapagliflozin alone. This Phase II, multicenter, randomized, double-blind study also assesses safety and tolerability of these treatments alongside standard care, including participants with or without type 2 diabetes mellitus. Participants not already using SGLT2 inhibitors will first receive dapagliflozin alone daily for 28 days during a run-in period. Then, all participants enter a 12-week double-blind treatment phase where they receive either the fixed-dose combination of zibotentan and dapagliflozin or dapagliflozin alone daily, with doses adjusted based on kidney function eGFR. After this period, participants stop the blinded treatment and continue open-label dapagliflozin alone for 4 weeks for safety follow-up. During the study, participants will have their urinary albumin to creatinine ratio UACR measured to evaluate kidney function at 12 weeks. Other assessments include urinary protein to creatinine ratio, blood pressure changes, and monitoring of any adverse events from the start of treatment through a follow-up visit 18 weeks after enrollment. The total participation includes screening, run-in, treatment, and safety follow-up periods, providing detailed data on the treatment effects and safety profile.

Researchers are studying aggressive high-volume metastatic hormone-sensitive prostate cancer mHSPC in male patients in the Russian Federation. This observational study focuses on treatment patterns and the evaluation of homologous recombination repair mutations HRRm in circulating tumor DNA ctDNA. The study aims to better understand demographic and clinical characteristics along with how patients with different HRR gene statuses are treated. The study enrolls about 400 male patients with high-aggressive Gleason 8-10 and high-volume mHSPC who have known tumor HRRm status from routine tumor samples. No additional procedures beyond routine clinical care are performed. Data are collected during two visits a baseline visit where medical history and treatment approaches since diagnosis are recorded, and a final visit at disease progression or after about 12 months to gather follow-up treatment and progression information. Blood samples for ctDNA and HRRm testing are collected from routine blood draws and analyzed centrally. Participants contribute data through medical record reviews and, if needed, patient interviews. Researchers collect information on treatments received, disease progression, lab tests, and mutation presence. The study evaluates various outcomes including treatment proportions, therapy durations, progression times, and mutation rates over 36 months. Data are entered into electronic forms, and follow-up may occur by phone if in-person visits are not possible. The total study duration is about 38 months or until all data are collected.

This research aims to assess the physical impact of Multiple Sclerosis MS from the participants perspective. It also provides participants continued access to the medication ocrelizumab while evaluating its safety and tolerability. The study is an open-label extension phase 3 trial sponsored by Hoffmann-La Roche, focusing on patients previously enrolled in related studies who currently lack local access to ocrelizumab treatment. Participants will receive ocrelizumab either as a 600 mg intravenous infusion or a 920 mg subcutaneous injection, following the dosing schedule established in their prior parent study. Treatment will continue until local access to the drug becomes available, if safety concerns arise, if the participant withdraws consent, or in the event of death. During the study, participants will be monitored for changes in physical functioning using patient-reported outcome measures over up to five years. Researchers will also track the number of participants receiving ocrelizumab and monitor adverse events, including serious or special interest events that may lead to discontinuation. Safety and tolerability assessments will continue throughout the study duration, which may last up to five years.

Researchers are conducting a national, multi-center, prospective study to collect real-world data on patients in the Russian Federation with advanced and aggressive endometrial cancer, specifically stage III-IV disease. The study focuses on molecular profiling markers such as POLE mutations, dMMRpMMR, p53 abnormalities, HER2 expression, and PD-L1 status, alongside demographic and clinical characteristics. It aims to understand first-line postoperative treatment approaches in these patients. The study involves no additional procedures beyond routine clinical practice. Patients provide archival tumor tissue samples obtained from biopsy or post-operative formalin-fixed paraffin-embedded FFPE blocks for molecular testing. Testing uses immunohistochemistry IHC for certain markers and next-generation sequencing NGS or polymerase chain reaction PCR for POLE mutations. Data will be collected at two visits a baseline visit to gather clinical and demographic information and tissue testing results, and a final visit 6 months later or at disease progression to collect follow-up treatment and progression data. Participants data and outcomes will be recorded in an electronic case report form. The study measures include rates of positive molecular markers and various clinical and treatment-related outcomes over 24 to 33 months. Approximately 500 patients will be enrolled across about 30 sites. The overall study duration is about 27 months or until data collection for all patients is complete.

Researchers are evaluating the efficacy and safety of BCD-248 as a treatment for patients with relapsed or refractory multiple myeloma, a condition where the disease has returned or is resistant to previous therapies. This open-label phase 2 clinical study aims to assess the overall response rate and other important outcomes in this patient population. The study is sponsored by Biocad and focuses on patients who have received multiple prior treatments including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 therapy. Participants will receive BCD-248 administered subcutaneously. The study monitors various outcomes including overall response rate up to 24 weeks and progression-free survival up to 104 weeks, among others, over a total duration extending to about 3.7 years for some measures. Pharmacokinetic parameters like Cmax, Cmin, AUC0-t, and Ctrough will be tracked shortly after administration and up to 6 months. Additional assessments include measurement of soluble BCMA levels and the presence of binding and neutralizing antibodies. During the study, participants will undergo regular evaluations including disease assessments based on International Myeloma Working Group criteria, safety monitoring for adverse events, and laboratory tests. Long-term follow-up will include evaluation of response duration, time to response and progression, and overall survival. The study started in December 2024 and is expected to continue until July 2028, providing extended observation for participant outcomes and safety.

This observational study focuses on adult patients diagnosed with neurofibromatosis type 1 NF1 in Russia. It aims to evaluate clinical characteristics and patient-reported outcomes in routine care settings to better understand the disease manifestations, associated symptoms, and complications in this population. The study is non-interventional and involves collecting data during regular healthcare visits without altering patient treatment. Participants are adults aged 18 years or older with a confirmed diagnosis of NF1 and plexiform neurofibromas PN identified by clinical assessment or imaging methods such as MRI or ultrasound. Patients must have PN-associated symptoms and be either newly diagnosed or nave to MEK-inhibitor therapy. The study does not involve experimental treatments but follows patients receiving standard care to gather clinical and demographic information. During the study, participants undergo evaluations at routine visits where data such as age at NF1 diagnosis, body measurements, symptoms, complications, and disability degree are collected. Imaging results, hospitalizations related to NF1, and medical histories are reviewed. Researchers monitor changes in disability and symptom persistence over time. The study includes assessments of PN volume by MRI and various patient characteristics to understand disease impact and progression. Participation duration aligns with routine care without additional interventions.

Researchers are conducting an observational multicenter cross-sectional study involving 5,000 adult patients in Russia with uncontrolled severe asthma SA who are receiving standard care treatments except biologics. The study aims to describe the characteristics of these patients across about 50 outpatient centers in 50 regions of Russia, addressing the lack of unified data on severe asthma epidemiology, complications, comorbidities, and treatment patterns in the country. Participants will have a single study visit where demographic and clinical data will be collected without any additional interventions or changes to their routine care. The study will gather information on treatment patterns, including the use of oral corticosteroids and various medication classes, and analyze clinical and demographic features such as age at diagnosis, gender distribution, body mass index, lifestyle factors, and presence of comorbidities. During the study, researchers will review medical records and follow-up data from the prior 52 weeks to assess treatment changes, exacerbations, healthcare resource use, and lung function parameters. No extra diagnostic or therapeutic procedures will be performed beyond standard practice. The study will run from June 2024 to June 2027, aiming to provide detailed epidemiological insights into uncontrolled severe asthma in the Russian adult population.