Sankt Peterburg

Researchers are evaluating two strategies for optimizing stent implantation during bifurcation stenting of the left main coronary artery LM in patients with coronary artery disease. This prospective, randomized, controlled trial compares an intravascular ultrasound IVUS-guided approach versus an IVUS-trained eye approach based on angiographic assessment and operator experience. The study aims to determine whether an angiography-based method performed by experienced physicians is non-inferior to the IVUS-guided technique regarding stent placement quality and planimetric characteristics immediately after the procedure. All patients receive the same type of coronary stent Calypso, R-Vascular, Russia to reduce variability. The IVUS-guided group undergoes baseline IVUS assessment to select and optimize stent placement with mandatory steps like kissing balloon dilation and proximal optimization. The angiography-guided group relies on visual angiographic evaluation for stent and balloon selection, with IVUS used only after the procedure to assess stent results. Both groups follow the same optimization steps and procedural techniques. Participants are monitored immediately after the procedure with IVUS imaging to measure stent expansion and quality. Follow-up assessments occur up to one year post-procedure to evaluate device-oriented composite endpoints. The study includes detailed procedural steps, imaging, and clinical outcome tracking to compare the two approaches. Total participation lasts through the intervention and one year of follow-up to assess safety and effectiveness outcomes.

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.

This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.

Researchers are evaluating the safety, pharmacokinetics, pharmacodynamics, and effectiveness of an investigational drug called GNR-055 in patients with Mucopolysaccharidosis Type II MPS II, also known as Hunter syndrome. This condition is a genetic disorder caused by a deficiency of the enzyme iduronate-2-sulfatase ID2S, leading to harmful buildup of certain substances in cells that affects growth, organs, and the nervous system. The study is a phase 23, multicenter, open-label trial involving different age groups to better understand how GNR-055 works and its safety profile. GNR-055 is a modified enzyme replacement therapy designed to cross the blood-brain barrier, potentially preventing neurological damage and improving quality of life for patients with MPS II. Participants receive weekly intravenous infusions of GNR-055 at doses ranging from 1.0 to 3.0 mgkg, depending on their study group. The study includes multiple cohorts, with adult and pediatric patients receiving specific dosing regimens over the trial period. During the study, participants will undergo various assessments including monitoring of adverse events, urine and serum levels of glycosaminoglycans GAG, cerebrospinal fluid analysis, joint motion measurements, MRI scans of liver, spleen, and brain, heart and lung function tests, neurocognitive evaluations, and biomarker analysis. These evaluations occur at baseline and multiple follow-up visits up to week 56. The study aims to gather detailed data on the drugs impact on disease symptoms, safety, and biological markers to inform future treatment options.

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 effects of Radotinib in patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia who have not responded well or cannot tolerate previous tyrosine kinase inhibitor treatments, including Imatinib. This multinational Phase III study aims to assess the efficacy and safety of Radotinib in this specific patient group. A total of 173 participants are expected to enroll in this single-arm, open-label trial. Participants will receive Radotinib at a dose of 400 mg twice daily, taken orally every 12 hours, for 12 months. Dose adjustments may be made if participants experience certain blood-related or other toxicities, with up to two reductions allowed per stage to 600 mg and then 400 mg. The study monitors patients closely to manage any side effects and ensure compliance with the dosing schedule. Throughout the study, participants will undergo regular assessments, including cytogenetic and molecular response evaluations at 6, 12, and 24 months. Researchers will track major cytogenetic response at 6 months as the primary outcome, with additional measures of overall survival and progression-free survival by 24 months. Safety and tolerability will also be monitored, with follow-up lasting up to two years to evaluate long-term effects and disease progression.

Researchers are evaluating the combination of APG-2575 Lisaftoclax and azacitidine compared to placebo combined with azacitidine in patients newly diagnosed with acute myeloid leukemia AML who cannot receive standard chemotherapy. This phase III, global, randomized, double-blind, placebo-controlled study aims to determine the effectiveness of this treatment approach in elderly or unfit AML patients. The study is sponsored by Ascentage Pharma Group Inc. and focuses on improving outcomes in this challenging population. Participants will be randomly assigned to receive either the investigational treatment of oral APG-2575 daily plus azacitidine injections or a placebo with azacitidine. Azacitidine is given by subcutaneous or intravenous injection on days 1 to 7 of each 28-day cycle, while APG-2575 or placebo is taken orally every day during each cycle. The treatment continues across multiple cycles with monitoring for up to five years, including evaluation of overall survival and response rates. During the study, participants will undergo regular assessments including safety evaluations, laboratory tests, and follow-up examinations to monitor treatment effects and adverse events. The primary outcome measured is overall survival over up to five years. Secondary outcomes include response rates and safety based on adverse event reports. Participants must be able to take oral medication, consent to the study, and complete all required procedures throughout the study period, which extends until 2029.

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.