| Статус: | Recruiting |
| Фаза: | Phase 3 |
| Начало: | 21 марта 2024 г. |
| Окончание: | 1 марта 2027 г. |
| Описание: | The aim of the study BCD-263-2/UNIVERSE is to demonstrate comparable efficacy and similar safety and immunogenicity profile of BCD-263 and Opdivo after repeated intravenous doses in subjects with advanced unresectable or metastatic melanoma of the skin. |
| смотреть на ClinicalTrials.gov |
| Статус: | Recruiting |
| Фаза: | Phase 1 |
| Начало: | 29 мая 2023 г. |
| Окончание: | 1 января 2027 г. |
| Описание: | The aim of the study BCD-263-1 is to prove the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-263 and Opdivo following intravenous administration to subjects with advanced unresectable or metastatic melanoma of the skin. The study will have randomized, double-blind design with parallel assignment. |
| смотреть на ClinicalTrials.gov |
| Статус: | Recruiting |
| Фаза: | Phase 3 |
| Начало: | 1 марта 2023 г. |
| Окончание: | 1 июня 2027 г. |
| Описание: | This study is an open-label, randomized, comparative phase III study, which will include subjects with resectable stage III skin melanoma (up to 3 resectable transient metastases are acceptable). |
| смотреть на ClinicalTrials.gov |
| Статус: | Recruiting |
| Фаза: | Phase 3 |
| Начало: | 30 января 2023 г. |
| Окончание: | 31 января 2026 г. |
| Описание: | The goal of this study is to compare the efficacy and safety of BCD-178 and Perjeta as neoadjuvant therapy for HER2-positive breast cancer. Subjects with histologically confirmed diagnosis of HER2-positive invasive breast cancer (stage II-III, tumor size > 2 cm), with no estrogen (ER) and progesterone (PR) receptors will be randomized to one of two treatment groups (BCD-178 group or Perjeta group) in a 1:1 ratio. |
| смотреть на ClinicalTrials.gov |
| Статус: | Recruiting |
| Фаза: | Phase 3 |
| Начало: | 2 августа 2022 г. |
| Окончание: | 1 апреля 2025 г. |
| Описание: | The aim of study is to investigate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of BCD-217 followed by prolgolimab monotherapy versus prolgolimab monotherapy as first-line therapy in subjects with unresectable or metastatic melanoma. |
| смотреть на ClinicalTrials.gov |
| Статус: | Recruiting |
| Фаза: | Phase 3 |
| Начало: | 1 октября 2019 г. |
| Окончание: | 1 декабря 2024 г. |
| Описание: | This is a randomized, multicenter, double-blind, Phase 3 study of efficacy and safety of BCD-100 plus platinum-based chemotherapy with and without bevacizumab versus placebo plus platinum-based chemotherapy with and without bevacizumab |
| смотреть на ClinicalTrials.gov |
| Статус: | Unknown status |
| Фаза: | Phase 3 |
| Начало: | 1 июня 2019 г. |
| Окончание: | 1 декабря 2023 г. |
| Описание: | This is a randomized, multicenter, double-blind placebo-controlled phase 3 study of efficacy and safety of BCD-100 in combination with pemetrexed+cisplatin/carboplatin compared to placebo in combination with pemetrexed+cisplatin/carboplatin in subjects with previously untreated metastatic non-squamous NSCLC. The main hypothesis of the study is that BCD-100 in combination with chemotherapy prolongs OS compared to placebo with chemotherapy. |
| смотреть на ClinicalTrials.gov |
| Статус: | Unknown status |
| Фаза: | Phase 2 |
| Начало: | 25 декабря 2018 г. |
| Окончание: | 7 июля 2020 г. |
| Описание: | This is a multicenter, open-label, single-arm study of efficacy, safety and pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) in combination with platinum-based chemotherapy and bevacizumab as first-line treatment in patients with recurrent/persistent or metastatic cervical cancer. |
| смотреть на ClinicalTrials.gov |
| Статус: | Unknown status |
| Фаза: | Phase 1 |
| Начало: | 31 октября 2017 г. |
| Окончание: | 31 октября 2018 г. |
| Описание: | A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-135 (JSC BIOCAD, Russia) in Patients with Advanced Solid Tumors |
| смотреть на ClinicalTrials.gov |