Core Viewpoint - CloudTop New Horizon (01952) has initiated a Phase I study to evaluate the safety, tolerability, and preliminary efficacy of EVM14 monotherapy in selected patients with solid tumors, specifically squamous non-small cell lung cancer and head and neck squamous cell carcinoma [2][5]. Group 1: Company Developments - CloudTop New Horizon's stock price increased by 6.02%, currently trading at HKD 40.18, with a trading volume of HKD 136 million [2][5]. - The Phase I trial aims to assess the safety and tolerability of EVM14, determining the recommended Phase II dose (RP2D) [2][5]. Group 2: Clinical Trial Objectives - The primary objective of the trial is to evaluate the safety and tolerability of EVM14 in patients with squamous non-small cell lung cancer and head and neck squamous cell carcinoma [2][5]. - Secondary objectives include assessing the anti-tumor activity of EVM14, while exploratory objectives involve examining the correlation between biomarker expression and efficacy, as well as evaluating immunogenicity, pharmacokinetics, and anti-drug antibodies [2][5]. Group 3: Product Information - EVM14 injection is a biopharmaceutical intended for the treatment of squamous non-small cell lung cancer and head and neck squamous cell carcinoma [2][5]. - Squamous non-small cell lung cancer is a common type of lung cancer characterized by symptoms such as cough and hemoptysis, diagnosed through imaging and pathology [2][5]. - Head and neck squamous cell carcinoma typically originates from mucosal surfaces, presenting with ulcers and masses, and is diagnosed through pathological examination [2][5].
云顶新耀早盘涨超6% 附属EVM14注射液启动I期临床