相关临床试验
13
4 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
2016
进行中（未招募）
4
30.8%
已完成
1
7.7%
招募中
8
61.5%
暂无批准数据
- CatalYm has dosed the first patient in the GDFATHER-HCC-01 trial, evaluating visugromab combined with nivolumab and lenvatinib for patients with unresectable or metastatic hepatocellular carcinoma who progressed after first-line anti-PD-(L)1 therapy. - The anti-GDF-15 antibody visugromab demonstrated encouraging anti-tumor activity in earlier trials, with a median duration of response of 21.4 months in advanced-stage, anti-PD-(L)1 relapsed/refractory HCC patients. - The global Phase 2b study will enroll approximately 104 participants across 40 sites, with progression-free survival as the primary endpoint and potential cachexia mitigation as an exploratory objective. - This represents CatalYm's third Phase 2b study of visugromab, expanding development into hepatocellular carcinoma following first and second-line NSCLC programs.
- The European Society for Medical Oncology (ESMO) 2025 Congress in Berlin showcased significant advances in antibody-drug conjugates (ADCs), with trastuzumab deruxtecan demonstrating superior efficacy in early-stage HER2-positive breast cancer with 67% pathologic complete response rates. - Artificial intelligence integration into clinical workflows gained momentum, with AI-driven chest X-ray tools achieving 96% accuracy in lung cancer detection and spatial awareness models enabling nuanced tumor microenvironment interpretation. - Previously undruggable targets like KRAS G12D showed promising therapeutic responses, with novel inhibitors achieving up to 41% objective response rates in heavily pretreated pancreatic cancer patients. - Circulating tumor DNA (ctDNA) emerged as a powerful biomarker for real-time treatment monitoring and minimal residual disease detection, enabling precision therapy adjustments and reducing overtreatment in multiple cancer types.
- Merck KGaA appointed Kai Beckmann as CEO following Belén Garijo's departure after 15 years with the company, while also naming David Weinreich as global head of R&D and chief medical officer. - GSK concluded Emma Walmsley's eight-year tenure as CEO, appointing Luke Miels as her successor, who brings extensive experience from leadership roles at AstraZeneca, Roche, and Sanofi-Aventis. - The pharmaceutical industry experienced widespread executive changes across biotech companies, with multiple CEO transitions and senior leadership appointments spanning oncology, regenerative medicine, and rare disease therapeutics. - Major pharmaceutical companies including Sanofi and Bristol Myers Squibb strengthened their leadership teams with new chief medical officers and oncology medical affairs heads.
- CatalYm has dosed the first patient in a randomized Phase 2b trial evaluating visugromab combined with chemoimmunotherapy as first-line treatment for metastatic non-squamous NSCLC. - The anti-GDF-15 antibody visugromab targets a tumor-derived cytokine that drives immune suppression and anti-PD-(L)-1 resistance, with previous trials showing deep and durable responses. - The GDFATHER-NSCLC-01 trial will enroll approximately 107 patients across multiple sites in the US, EU, and Switzerland, with objective response rate as the primary endpoint. - Results from a separate Phase 2 neoadjuvant bladder cancer trial combining visugromab with nivolumab will be presented at ESMO 2025 as a late-breaking oral presentation.
- CatalYm appointed four experienced executives to accelerate visugromab's progression into late-stage clinical development following promising Phase 2a results. - The company's GDFATHER-2 trial demonstrated that visugromab combined with anti-PD-1 inhibitor produced deep and durable responses across multiple solid tumor types with favorable safety. - CatalYm is advancing visugromab into multiple Phase 2b studies including first-line metastatic NSCLC and cachexia indications based on Nature-published data. - The leadership changes position the GDF-15-targeting therapy developer for potential regulatory approval and commercial success in oncology and cachexia markets.
- New preclinical data reveals that visugromab, CatalYm's GDF-15-neutralizing antibody, significantly enhances the anti-tumor activity of antibody-drug conjugates (ADCs) in multiple solid tumor models. - Research demonstrates that ADC treatment triggers GDF-15 expression as a potential resistance mechanism, which visugromab effectively counteracts by improving immune cell infiltration and activation in the tumor microenvironment. - These findings build on CatalYm's previous clinical evidence showing visugromab's ability to induce durable responses in relapsed/refractory solid tumors and mitigate cancer-associated cachexia.
