Kursk

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 evaluate the effectiveness and safety of intra-arterial intrathrombus administration of recombinant non-immunogenic staphylokinase Fortelyzin4 compared to surgery in patients experiencing acute limb ischemia ALI. ALI is a serious condition with high mortality, and this study focuses on a thrombolytic treatment that targets clot breakdown directly within affected arteries. The trial builds on previous studies showing promising results with this staphylokinase in heart attacks and strokes, assessing its role specifically in ALI. Participants will be randomly assigned to receive either Fortelyzin4 delivered directly into the blood clot via a catheter or surgical treatment including endovascular intervention, open surgery, or bypass surgery based on current national guidelines. The Fortelyzin4 treatment involves an initial bolus injection followed by a continuous infusion over ten hours through a perforated multihole catheter. Surgery will be conducted according to standard practice. This is an open-label, multicenter Phase 3 trial. During the study, participants will be monitored for 30 days after randomization to assess outcomes, focusing primarily on the number of patients who avoid amputation. Assessments will include safety monitoring for bleeding and other adverse events. Informed consent and contraception adherence are required, and ongoing patient evaluations will help researchers understand the comparative benefits and risks of these treatment approaches for ALI.