相关临床试验
11
0 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
2011
已完成
8
72.7%
终止
2
18.2%
Unknown
1
9.1%
暂无批准数据
- The randomized Phase 2 DeFianCe study demonstrated that baseline plasma DKK1 levels predict deepening benefit from sirexatamab when added to bevacizumab and chemotherapy in second-line metastatic colorectal cancer patients. - In DKK1-high patients above the median, sirexatamab improved median PFS to 9.0 months versus 7.1 months (HR 0.61; p=0.0255) and median OS was not reached versus 14.4 months (HR 0.42; p=0.0118). - Among upper-quartile DKK1-high patients, the OS hazard ratio was 0.17 (p<0.001), with median OS not reached versus 9.5 months, while ORR reached 44.0% compared with 15.8% in the control arm. - The findings, published in Clinical Cancer Research, provide the scientific foundation for a biomarker-selected Phase 3 registrational trial, with the FDA having granted Fast Track designation in May 2026.
- Leap Therapeutics reached FDA alignment on a registrational Phase 3 trial of sirexatamab in DKK1-high, second-line metastatic colorectal cancer (mCRC), with objective response rate supporting accelerated approval and overall survival supporting full approval. - The randomized Phase 2 DeFianCe study, published in Clinical Cancer Research, showed sirexatamab's benefit increases with rising baseline plasma DKK1 levels, defining DKK1-high mCRC as a biologically distinct population with high unmet need. - Sirexatamab received FDA Fast Track designation in May 2026 for DKK1-high mCRC patients whose disease has progressed following one prior systemic therapy. - Leap Therapeutics has initiated a strategic process to advance sirexatamab, considering options including an independent spin-out or a partnership with a pharmaceutical or biotechnology company.
- Leap Therapeutics has restructured its economics through a royalty agreement and secured new funding to extend its cash runway while advancing its lead oncology programs. - The company's anti-DKK1 antibody DKN-01 is being tested in combination approaches for solid tumors, including gastroesophageal and gynecologic cancers with biomarker-guided patient selection. - The financing strategy trades long-term upside for near-term survival, buying time to generate value-driving clinical data from its targeted antibody programs. - As a clinical-stage biotech with no commercial revenue, Leap's valuation remains highly dependent on trial outcomes and potential partnerships with larger pharmaceutical companies.
- Compass Therapeutics appointed Arjun Prasad as Chief Commercial Officer and Cynthia Sirard as Chief Medical Officer, both effective January 1, 2026. - Prasad brings extensive commercial experience including over 10 successful oncology launches, notably the blockbuster VORANIGO launch in 2024 and TIBSOVO for biliary tract cancer patients. - Sirard contributes more than two decades of oncology drug development expertise, having guided multiple programs through clinical development, pivotal trials, and regulatory approval. - The appointments strengthen Compass's execution capabilities as the company advances tovecimig and its broader immuno-oncology pipeline toward potential commercialization.
- Leap Therapeutics will present final clinical results from the DeFianCe Phase 2 study evaluating sirexatamab (DKN-01) plus bevacizumab and chemotherapy versus standard care in advanced microsatellite stable colorectal cancer. - The randomized trial tested sirexatamab, an anti-DKK1 monoclonal antibody, as second-line therapy in patients who received one prior systemic treatment for advanced disease. - Results will be presented at the European Society for Medical Oncology Congress 2025 in Berlin on October 19, highlighting potential advances in colorectal cancer treatment.
- DelveInsight's 2025 pipeline report reveals over 200 companies developing 220+ therapeutic candidates for gastric cancer treatment across all clinical stages. - Recent clinical developments include Bold Therapeutics' Phase 1b/2a study of BOLD-100 with FOLFOX chemotherapy and Jazz Pharmaceuticals' zanidatamab combination trials. - Leading pipeline candidates include tislelizumab (BeiGene), catumaxomab (Linton Pharm), and tivumecirnon (RAPT Therapeutics) targeting various mechanisms from PD-1 inhibition to regulatory T cell migration. - The pipeline encompasses diverse therapeutic approaches including monoclonal antibodies, small molecules, and combination therapies targeting novel mechanisms like Claudin 18.2 and DKK1 signaling.
- CASI Pharmaceuticals' stock surged 57.2% to $2.028 after the FDA cleared its IND application for CID-103, an anti-CD38 monoclonal antibody targeting kidney transplant rejection. - The Phase 1 trial will evaluate CID-103 in adults with active and chronic active renal allograft antibody-mediated rejection, addressing an $800 million to $1.2 billion unmet medical need. - Trading volume spiked 2,043% to 62.9 million shares, indicating strong institutional interest in the regulatory milestone. - The FDA clearance positions CID-103 as a potential best-in-class therapy for antibody-mediated rejection, where current treatments face safety limitations.
- Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions. - The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success. - This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.
- Leap Therapeutics' novel GDF-15 neutralizing antibody FL-501 demonstrated superior efficacy in preclinical models, fully restoring body composition and reversing key indicators of cancer cachexia. - The antibody showed a 2-3-fold longer half-life and 50% reduced clearance compared to competing therapies, positioning it as a potential best-in-class treatment for the devastating condition. - With no effective treatments currently available for cancer cachexia, Leap Therapeutics plans to advance FL-501 into clinical trials by 2026, potentially addressing a significant unmet medical need.
- Leap Therapeutics' anti-DKK1 antibody sirexatamab shows promising results in colorectal cancer trials while falling short in gastric cancer studies, leading to significant stock impact. - The mixed Phase II trial outcomes highlight the complex nature of targeting gastrointestinal tumors with combination therapy approaches. - Company's stock experienced a 71% decline following the announcement, closing at $0.66 per share on January 28.
