近日药物临床试验登记与信息公示平台公示华润双鹤孙公司双鹤润创自Novita Pharma引进的Fascin蛋白抑制剂DC05F01进入国内临床——《评价DC05F01在中国晚期或转移性实体瘤患者中的安全性、耐受性、药代动力学特征及初步疗效的开放、剂量探索的Ⅰ期临床试验》（CTR20221006），计划招募18位受试者。
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2021年7月，华润双鹤通过创新事业部从美国Novita Pharmaceuticals, Inc.（诺维塔制药有限公司，简称“NOVITA”）引进了Fascin蛋白抑制剂，并命名为DC05F01用于后续的研发注册工作，为华润双鹤2021年第一个跨境创新药合作项目。该产品是作用于Fascin蛋白的小分子化合物，前期研究发现能够有效抑制Fascin蛋白活性，从而降低肿瘤侵袭和转移，未来可作为一种潜在控制肿瘤转移的口服药物。
Under the terms of the agreement, Novita will receive an upfront payment of $15 million and additional payments upon reaching certain development and regulatory milestones, of up to $300 million for multiple cancer indications. Novita is also eligible to receive tiered royalties based on net sales. CRDC will receive the rights to research, develop, manufacture, and exclusively commercialize Novita's fascin inhibitor in oncology applications in the Greater China region.
4月7日，华润双鹤发布公告，全资孙公司北京双鹤润创科技有限公司药品DC05F01（胶囊剂，100mg）于近日获得国家药监局《药物临床试验批准通知书》（通知书编号：2022LP00558），获批该药品开展单药在实体瘤患者中的临床试验。截至目前，DC05F01相关研发项目累计已投入研发费用约1.49亿元。
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Novita的Fascin蛋白抑制剂NP-G2-044已在美国完成1期单药用于实体瘤患者的临床研究（NCT03199586），联合抗PD-(L)1疗法1/2期临床（NCT05023486）进行中，此前2021年5月Novita在ASCO发表的NP-G2-044数据显示未看到正式基于RECIST标准的客观应答，仅观察到抗肿瘤的早期信号。
| Improving fascin inhibitors to block tumor cell migration and metastasis |
| settings Open AccessArticle Fascin Inhibitors Decrease Cell Migration and Adhesion While Increase Overall Survival of Mice Bearing Bladder Cancers |
"While no formal RECIST-based objective responses were observed, consistent with the drug’s non-cytotoxic mechanism of action, preliminary signals of anti-tumor and anti-metastatic activity were observed. These include dose proportional increases in duration of treatment, progression-free-survival, and metastasis-free interval, in particular for 4/4 late-stage ovarian cancer patients (table). Comparison of time on treatment (TOT) for ovarian cancer patients."
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