The approval from the Ministry of Healthcare and Social Development of the Russian Federation has been obtained for the initiation of the phase Ib multiple dose escalation clinical study in patients with advanced solid tumors. Four clinical sites are planned for this study, and a back-up site as a strategic contingency plan. A maximum of 48 patients will participate in this study (several cohorts in the first part of the study followed by the dose escalating part in other patients). These are patients who are resistant to standard care treatment. The major clinical study objective is to define the maximum tolerable dose as well as dose-limiting toxicity. Among other objectives, it is planned to assess the anti-tumor activity of the drug, to evaluate the safety profile of the investigational product, its pharmacokinetics parameters.
The full package of documents elaborated by Sponsor and OCT was submitted to the Ministry of Health and Social Development of the Russian Federation in order to obtain the approval for the clinical trial to be initiated.
Due to well-established long-term relationship with the experienced oncology sites, it became possible to include them into the clinical trial. The leading scientists and doctors will be acting as principal investigators in this study. Among the clinical hospitals, there are several most experienced Russian oncology institutions. The profound specific knowledge of the doctors in the sphere, as well as enormous experience in the field allow for high-quality compliance with the protocol requirements and the ethics principles. The design of the study requires excellent skills and knowledge from the investigators and their team to carefully treat the patients, adhere to medications administration, perform the necessary procedures, etc.
The Sponsor believes that after the full completion of the drug development programme, this medication will become available for patients and will serve for the sake of patients` prolonged life, digress of the disorder and the improved health and life conditions.