相关临床试验
30
14 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1983
进行中（未招募）
14
46.7%
已完成
3
10.0%
招募中
10
33.3%
终止
3
10.0%
暂无批准数据
- BioInvent's Phase 2a study demonstrates that BI-1808 combined with pembrolizumab achieved a 24% overall response rate in recurrent ovarian cancer patients, representing a three-fold improvement over pembrolizumab monotherapy's 8% response rate. - The combination therapy showed a favorable safety profile with manageable adverse events and achieved a 65% disease control rate among 17 evaluable patients. - The company plans to expand the ovarian cancer cohort by enrolling an additional 20 patients focusing on high-grade serous and clear cell subtypes, with data readout expected in the second half of 2026.
- BioInvent will present preliminary Phase 1 clinical data for BI-1910, a TNFR2 agonist for solid tumors, at the SITC Annual Meeting in November 2025. - The Phase 1 dose escalation study was completed without notable adverse events, with six of 12 evaluable patients showing stable disease. - Despite positive safety results, BioInvent has paused BI-1910 development to focus resources on its more advanced BI-1808 program following a strategic review. - BI-1910 demonstrated favorable pharmacokinetics and robust target engagement, with evidence of T cell proliferation induction in patients within the target dose range.
- Transgene and BioInvent will present updated Phase I data on BT-001, an armed oncolytic virus expressing anti-CTLA-4 antibody, at the ESMO Annual Meeting in Berlin from October 17-21, 2025. - BT-001 demonstrated clinical responses in two out of six refractory patients when combined with pembrolizumab, showing shrinkage of both injected and non-injected lesions. - The treatment successfully converted "cold" tumors into "hot" ones by inducing T-cell infiltration and PD(L)-1 expression in the tumor microenvironment. - The ongoing Phase I/IIa study (NCT04725331) evaluates BT-001 as monotherapy and in combination with pembrolizumab, with the last Phase I patient enrolled in August 2024.
- BioInvent's Phase 1 study of BI-1206 combined with pembrolizumab demonstrated encouraging clinical activity in heavily pre-treated solid tumor patients, with one complete response and one partial response among 36 evaluable patients. - The combination therapy was well-tolerated and showed potential to overcome resistance mechanisms to anti-PD-1 treatment by targeting FcγRIIB expressing immune cells. - Based on these promising results, BioInvent plans to initiate Phase 2a expansion cohorts in H2 2025 for treatment-naïve patients with advanced NSCLC and uveal melanoma. - The study supports transitioning from intravenous to subcutaneous formulation of BI-1206, which may enhance therapeutic impact and improve safety profiles.
- BioInvent successfully developed a population model to characterize BI-1910 pharmacokinetics and pharmacodynamics across a broad dose range, supporting optimal dose selection for upcoming Phase 2a studies. - The anti-TNFR2 agonist antibody demonstrated stable disease in six out of 12 evaluable patients during Phase 1 dose escalation, with favorable pharmacokinetics and robust target engagement inducing T cell proliferation. - Phase 2a studies of BI-1910 as both single agent and in combination with pembrolizumab are planned to initiate in the second half of 2025, targeting hepatocellular cancer and other solid tumors.
- BioInvent's Phase 2a study of BI-1206 in combination with rituximab and Calquence® shows a 63% objective response rate in the first eight non-Hodgkin's lymphoma patients evaluated. - The triple combination therapy demonstrated disease control in all patients (100% DCR), with two complete responses, three partial responses, and three stable disease outcomes, while maintaining a manageable safety profile. - This novel approach targets Fcγ RIIB to potentially overcome rituximab resistance in previously treated NHL patients, with data to be presented at the European Hematology Association 2025 congress.
- BioInvent's first-in-class anti-TNFR2 antibody BI-1808 receives FDA Orphan Drug Designation for treating T-cell lymphoma, providing development incentives and seven years of market exclusivity. - Recent Phase 2a clinical trial data showed promising efficacy in cutaneous T-cell lymphoma patients, with three partial responses and one stable disease among four evaluable patients who had previously failed standard treatments. - The designation supports BioInvent's strategy to develop novel immunomodulatory therapies for rare cancers, addressing the significant unmet need among approximately 3,000 new CTCL cases diagnosed annually in the United States.
- Initial data from BioInvent's Phase 1/2a study shows promising efficacy with BI-1206 combined with rituximab and Calquence in non-Hodgkin's lymphoma, with one complete response and one partial response in the first two patients. - The triple combination therapy has demonstrated a favorable safety profile with no tolerability concerns, allowing the study to expand to additional clinical sites across Spain, Germany, the US, and Brazil. - Patient enrollment remains on schedule with approximately 30 patients expected to participate in the trial, and further Phase 2a results anticipated by mid-2025.
