Spots Global Cancer Trial Database for The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors
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Trial Identification
Brief Title: The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors
Official Title: Single-arm, Open, Multi-center Phase I/Phase II Clinical Study to Assess the Safety, Tolerability, Pharmacokinetic and Effectiveness of VC004
Study ID: NCT04614740
Interventions
Study Description
Brief Summary: 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 .
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anhui Provincial Cancer Hospital, Hefei, Anhui, China
Chongqing University Cancer Hospital, Chongqing, Chongqing, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
Guangxi Medical University Affiliated Tumor Hospital, Nanning, Guangxi, China
Hainan Cancer Hospital, Haikou, Hainan, China
Henan Cancer Hospital, Zhengzhou, He Nan, China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Harbin Medical Univercity Cancer Hospital, Harbin, Heilongjiang, China
Hunan Cancer Hospital, Changsha, Hu Nan, China
Jiangsu Province Hospital of Chinese Medicine, Nanjing, Jiang Su, China
Shandong Cancer Hospital, Jinan, Shandong, China
Shanghai Tenth People's Hospital, Shanghai, Shanghai, China
Shanxi Provincial Cancer Hospital, Taiyuan, Shanxi, China
Yunnan Cancer Hospital, Kunming, Yunnan, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, , China
Zhujiang Hospital of Southern Medical University, Guangzhou, , China
Liaoning Cancer Hospital & Institute, Shenyang, , China
Tianjin Cancer Hospital, Tianjin, , China
Hubei Cancer Hospital, Wuhan, , China
The First Affiliated Hospital of Xinjiang Medical University, Ürümqi, , China
Contact Details
Name: yuankai shi
Affiliation: Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Role: PRINCIPAL_INVESTIGATOR
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