Moskva

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 studying the use of sarilumab, a drug given by injection, in children and adolescents aged 1 to 17 years who have systemic juvenile idiopathic arthritis sJIA. The study aims to understand how the drug behaves in the body, its effects, and its long-term safety for treating this condition. This trial is a phase 2, open-label study sponsored by Sanofi, designed to find the best dose and treatment schedule for young patients with sJIA. Participants will receive sarilumab injections under the skin at doses that increase during the study based on body weight. The treatment includes a 12-week core phase where patients receive the drug, followed by a 144-week extension phase for continued treatment. After completing treatment, a 6-week follow-up period will monitor patients. The study includes careful dose adjustments and long-term observation to assess the drugs impact. Throughout the study, participants will undergo various assessments including blood tests to measure drug levels, evaluations of disease activity using scales like the Investigator Global Assessment and ParentPatient Global Assessment, and tracking of symptoms and medication use. Safety will be monitored continuously by recording any side effects or local reactions to injections. The total participation time is about 166 weeks, during which the researchers will collect data on how well sarilumab works and how safe it is for children and adolescents with sJIA.

This research is an extension study for participants with cancer who have been previously enrolled in a Genentech andor F. Hoffmann-La Roche sponsored study. It aims to provide continued treatment with Roche investigational medicinal products IMPs either as monotherapy or combined with other agents for those still on study treatment at the time of rollover, particularly when local access to the study treatment is not available. The study is open-label and multicenter, focusing on long-term treatment continuation under medical supervision. Participants will continue receiving Roche IMPs following the same dose, schedule, and administration guidelines as in the parent study. Treatments include monotherapy or combination therapy with drugs such as Ipatasertib, Tiragolumab, Atezolizumab, Bevacizumab, Entrectinib, Inavolisib, and Divarasib. Treatment continues until disease progression, loss of clinical benefit, death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, local treatment availability, or study termination. During the study, participants are monitored for ongoing treatment benefits and adverse events as assessed by standard criteria. Researchers measure the number of participants maintaining access to Roche IMP-based therapy and track the number and severity of selected adverse events over up to approximately 10 years. Safety and treatment effectiveness are evaluated regularly, with participant follow-up continuing as long as treatment is administered or until study completion.

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 evaluating the safety and effectiveness of ozanimod RPC1063 in helping children and teenagers with moderate to severe active ulcerative colitis UC who have not responded well to standard treatments. The study focuses on whether ozanimod can help achieve and maintain clinical remission in this young population. This research is conducted as a phase 2 and phase 3 trial sponsored by Bristol-Myers Squibb. Participants will receive ozanimod orally in either a high dose or low dose as part of the study. The treatment is given on specified days, and participants are randomly assigned to one of these dosing groups. The study uses a quadruple masking design, meaning that participants, caregivers, investigators, and assessors do not know which dose is given. The main study period will last up to 52 weeks, with ongoing assessments for up to 6 years to monitor longer-term outcomes and safety. During the study, participants will be monitored regularly for clinical remission, symptomatic remission, clinical response, and endoscopic improvement at various time points including weeks 10 and 52. Researchers will also track corticosteroid-free remission and measure blood levels of the drug and its metabolites. Safety is closely observed by recording adverse events, serious adverse events, and events leading to treatment discontinuation. The study involves clinical visits, endoscopic exams, and laboratory tests throughout the treatment and follow-up periods.