研究单位：[1]Jiangsu vcare pharmaceutical technology co., LTD[2]Chongqing University Cancer Hospital Chongqing, Chongqing, China, 400030[3]Fujian Cancer Hospital Fuzhou, Fujian, China, 350001[4]Guangxi Medical University Affiliated Tumor Hospital Nanning, Guangxi, China, 530021[5]Hainan Cancer Hospital Haikou, Hainan, China, 570312[6]Henan Cancer Hospital Zhengzhou, He Nan, China[7]The Fourth Hospital of Hebei Medical University Shijiazhuang, Hebei, China, 050000河北医科大学第四医院[8]Harbin Medical Univercity Cancer Hospital Harbin, Heilongjiang, China, 150081[9]Hunan Cancer Hospital Changsha, Hu Nan, China[10]Jiangsu Province Hospital of Chinese Medicine Nanjing, Jiang Su, China[11]Shandong Cancer Hospital Jinan, Shandong, China, 250117[12]Shanghai Tenth People's Hospital Shanghai, Shanghai, China, 200072[13]Shanxi Provincial Cancer Hospital Taiyuan, Shanxi, China, 030013[14]Yunnan Cancer Hospital Kunming, Yunnan, China, 650106[15]Zhejiang Cancer Hospital Hangzhou, Zhejiang, China, 310022[16]Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College Beijing, China[17]Zhujiang Hospital of Southern Medical University Guangzhou, China[18]Liaoning Cancer Hospital & Institute Shenyang, China[19]Tianjin Cancer Hospital Tianjin, China[20]Hubei Cancer Hospital Wuhan, China[21]The First Affiliated Hospital of Xinjiang Medical University Ürümqi, China[22]Anhui Provincial Cancer Hospital Hefei, Anhui, China, 230001
Dose-escalation study will be conducted in patients with locally advanced/metastatic solid tumors who have failed standard treatment, or cannot tolerate standard treatment, or have no recommended standard treatment, or do not apply standard treatment, to evaluate the safety, PK, tolerability and effectiveness of VC004. According to the efficacy, safety and PK of dose-escalation study , the investigator and the sponsor jointly determine the dose for dose extension, and evaluate the anti-tumor effect of VC004 on NTRK fusion-positive subjects, and provide more information for RP2D.
According to the tolerability and pharmacokinetic results of dose-escalation study , an appropriate dose or MTD will be selected, namely RP2D, to further assess anti-tumor efficacy and safety in patients with NTRK fusion-positive locally advanced/metastatic solid tumors . ORR will be chosen as the main efficacy indicator to evaluate the anti-tumor efficacy and safety of VC004 .
