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Researchers are evaluating the pharmacokinetics, safety, and immune response of two drugs, RPH-030 and Vectibix4, in patients with metastatic colorectal cancer mCRC who have wild-type RAS genes. The study aims to show that these treatments are equivalent in how the body processes them and to compare their safety and immune effects. Additionally, the study will explore how effective these drugs are when used as first-line therapy combined with FOLFIRI chemotherapy. Participants will receive either RPH-030 or Vectibix4 intravenously at 6 mgkg every two weeks along with FOLFIRI chemotherapy, which includes irinotecan, calcium folinate, and fluorouracil. Treatment starts with FOLFIRI for 8 cycles, then continues with a modified de Gramont regimen. The study includes several periods a screening phase, a main period lasting up to 6 months, a continued therapy period up to 1 year where all patients receive RPH-030, and a treatment extension period lasting up to 2 years for patients with stable disease or response. Follow-up visits occur after treatment ends to monitor survival and disease status. Participants will undergo regular tumor assessments approximately every 6 to 8 weeks, hospitalizations for drug administration at specific visits, and blood sampling for pharmacokinetic and safety evaluations. Researchers will monitor drug levels over time, adverse events, immune reactions, and tumor responses. Follow-up includes imaging or phone calls to track overall survival and disease progression. The total study participation can last up to about 2 years with additional follow-up to ensure thorough monitoring of outcomes and safety.

Researchers are evaluating the safety and effectiveness of a new bevacizumab drug made by Mabscale, LLC, compared to Avastin, both combined with paclitaxel and carboplatin, for treating adults with advanced or inoperable non-squamous non-small cell lung cancer NSCLC. This phase III trial aims to show that the new bevacizumab works as well and is as safe as Avastin. The study also looks at how the drug is processed in the body. Participants are randomly assigned to one of two groups. One group receives the Mabscale bevacizumab with paclitaxel and carboplatin, and the other gets Avastin with the same chemotherapy drugs. Treatment cycles last about three weeks, with up to six cycles initially. After that, eligible patients continue with bevacizumab alone every three weeks. The study is double-blind, so neither patients nor researchers know who receives which bevacizumab. During the study, patients will undergo regular assessments including tumor measurements and blood tests. Researchers measure the tumor response at 18 weeks and track progression-free and overall survival at 18 and 42 weeks. The duration of response is also evaluated up to 48 weeks. Safety and side effects are closely monitored throughout the trial, which started in 2023 and will continue until 2027. Participants are followed closely to assess the treatments impact and safety.

Researchers are studying the safety and effects of a medicine called Mevrometostat for treating three types of cancer RelapsedRefractory Small Cell Lung Cancer SCLC, Castration Resistant Prostate Cancer CRPC, and Follicular Lymphoma FL. This study is a Phase 1 trial that includes three parts, with Parts 1 and 2 now closed for enrollment. The current enrollment is open for men with CRPC who have previously been treated and whose disease has progressed since their last treatment. The purpose is to evaluate how Mevrometostat works alone or combined with other treatments in these cancers. The study involves giving Mevrometostat by mouth either alone or with other drugs such as Enzalutamide and Itraconazole, depending on the specific part or cohort. Part 3 consists of two substudies a Bioequivalence BE substudy where participants take three single doses of two Mevrometostat formulations over three periods, and a Drug-Drug Interaction DDI substudy with two cohorts receiving Mevrometostat alone or combined with Enzalutamide andor Itraconazole. After these assessment phases, participants enter a maintenance phase where they take Mevrometostat twice daily and Enzalutamide once daily until the cancer no longer responds. During the study, participants will be closely monitored for safety, including adverse events, laboratory tests, and vital signs over about two years. The researchers will also assess how well the drug works by measuring cancer response and progression-free survival. Pharmacokinetic studies will track how the drug behaves in the body. Patient experiences and symptoms will be evaluated through questionnaires. Overall, participants can expect regular visits to receive the study drugs, undergo testing, and provide feedback throughout their participation, which may last until disease progression or study completion.

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 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.

Researchers are evaluating the effectiveness, safety, how the body processes, and immune response to BCD-236 combined with chemotherapy in women with relapsed or metastatic triple negative breast cancer TNBC who have received previous treatments. This is a Phase 2 study that compares BCD-236 plus chemotherapy versus chemotherapy alone in patients whose cancer has returned or progressed after earlier therapies. Participants will be randomly assigned to one of two groups one receiving BCD-236 by intravenous infusion plus chemotherapy chosen by the investigator, and the other receiving chemotherapy alone. Treatment continues until the cancer worsens, side effects become intolerable, or the study ends. During the study, participants will undergo regular assessments including tumor measurements and health evaluations to monitor response and side effects. The main outcome measured is the overall response rate at 24 weeks, with secondary outcomes including progression-free survival, overall survival, disease control rate, time to response, and duration of response assessed at various times up to 102 weeks. Participants will be monitored closely throughout their treatment and follow-up periods.

Researchers are studying BI-1808, given alone or with pembrolizumab, in people with advanced cancers that have worsened after standard treatments. This early-phase trial aims to find out how safe and tolerable BI-1808 is, determine the highest dose that can be given, and select doses for future studies. The trial includes subjects with advanced solid tumors and T-cell lymphoma. Participants receive BI-1808 as an intravenous infusion every 3 weeks, either by itself or combined with pembrolizumab. The study has two main parts Phase 1 includes dose escalation to assess safety and find recommended doses, and Phase 2a expands treatment at those doses to further evaluate safety, drug behavior in the body, and preliminary effects on tumors. During the trial, participants undergo regular assessments including monitoring for side effects, blood tests to study the drugs behavior and immune effects, and imaging to measure tumor response. Safety is followed for up to two years, with evaluations of adverse events, serious adverse events, and dosing limits. The study also examines tumor response rates and progression-free survival to understand treatment impact over time.

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.

Researchers are conducting a multicenter, double-blind, placebo-controlled, randomized clinical trial to study children aged 3 to 12 years with acute respiratory viral infection ARVI. This trial aims to evaluate the safety and effectiveness of Raphamin in treating ARVI symptoms during the seasonal incidence of the illness. Enrollment starts with children aged 6 to 12 years and may expand to include those aged 3 to 12 years based on interim safety and efficacy results. Participants will be randomly assigned to receive either Raphamin or a placebo. Raphamin is given orally as tablets that dissolve in the mouth, with a specific dosing schedule over five days eight tablets on the first day taken at intervals, then one tablet three times daily on days two through five. The placebo group follows the same dosing regimen using placebo tablets. The treatment period lasts five days, followed by monitoring and follow-up visits. During the study, parents or caregivers will record their childs symptoms and body temperature twice daily in an electronic diary, including any use of fever-reducing medications and changes in health. Children will have several visits with healthcare providers on days 1, 5, and 7, plus a phone visit on day 14 for safety and symptom assessment. Laboratory tests and physical exams will be conducted to monitor progress and safety. The primary outcome is the time until ARVI symptoms resolve within 14 days.