Kursk

Researchers are evaluating the pharmacokinetics, safety, and immune response of two treatments, RPH-030 and Vectibix®, in patients with metastatic colorectal cancer (mCRC) who have wild-type RAS genes. This phase I, multicenter, double-blind, randomized study aims to demonstrate that these treatments have equivalent pharmacokinetic properties when given as first-line therapy in combination with the chemotherapy regimen FOLFIRI. The study also includes a pilot evaluation of the efficacy of these treatments. Participants will be randomly assigned to receive either RPH-030 or Vectibix® intravenously at a dose of 6 mg/kg every two weeks alongside FOLFIRI chemotherapy. Treatment will continue for up to two years or until disease progression, unacceptable toxicity, or withdrawal of consent. The study is divided into several periods: a screening period lasting up to 27 days (extendable to 42 days if biopsy is needed), a 6-month main treatment period, a continued therapy period up to one year, a treatment extension period for responders lasting up to two years, and a follow-up period after treatment ends. During the study, patients will undergo regular tumor assessments approximately every 6 to 8 weeks depending on the study phase. Hospitalizations of at least 24 hours will occur at certain visits for drug administration. Researchers will monitor drug levels in the blood at multiple time points to understand treatment pharmacokinetics. Follow-up will include imaging tests, survival data collection, and safety monitoring until one year after treatment or until patient withdrawal or death. The goal is to assess treatment safety, immune response, effectiveness, and patient well-being throughout the study timeline.

Researchers are investigating the effectiveness and safety of using recombinant non-immunogenic staphylokinase (Fortelyzin4) administered directly into the artery at the site of the clot in patients with acute limb ischemia (ALI) compared to traditional surgery. This phase 3 clinical trial focuses on patients with ALI of degrees I to II b, aiming to find better treatment options since intravenous thrombolysis is ineffective for this condition. Previous studies with Fortelyzin4 in heart attack and stroke patients showed promising results with fewer bleeding complications and no immune reactions. The study compares two treatment approaches: intra-arterial thrombolysis with Fortelyzin4, a fibrin-selective clot-busting drug given as a lyophilisate solution, and surgical methods including endovascular intervention, open surgery, or bypass surgery following national guidelines. Patients will be randomly assigned to either receive Fortelyzin4 directly at the clot or undergo one of the surgical procedures. The trial is open-label and conducted at multiple centers. Participants will be monitored to see if they avoid amputations within 30 days after treatment. Researchers will assess safety and effectiveness through clinical evaluations and track adverse events. Informed consent and contraceptive use during and after the study are required for participants. The study includes follow-up to measure outcomes and ensure participant safety over the trial period.