1. Dose escalation stage: subjects in the 50 mg, 100 mg, 200 mg, and 300 mg dose groups took a single oral dose on the first day; starting from the fourth day, each group of subjects took the corresponding dose twice a day. 2. Dose expansion stage: subjects in the 100mg and 200mg dose groups took the corresponding dose twice a day on an empty stomach; 3. Phase II clinical trial stage: oral administration twice a day before meals, and the dosage is to be determined.

25 mg capsules,50 mg capsules,100 mg capsules.

VC004

xiaojuan lai

Jingmo Yang

Hu Li

Yuanyuan Yin

Yongsheng Li

Ping Huang

Yu Chen

Yu Lei

Hongxue Wang

Xie Weimin

Lin Na

Zhixia Wei

Yuefang Cheng

Suxia Luo

Jiaqiang Wang

Zhuo Sun

Da Jiang

Xiang Li

Qingyuan Zhang

Yun Jiang

Gang Huang

Jungang Yin

Jun Qian

Huijuan Li

Dongyuan Zhu

Fei Teng

Qing Xu

Guozhong Wang

Shuqing Wei

Sanhua Na

Yanbin Xiao

Feiyan Li

Meiyu Fang

Ning Li

Yuankai Shi

Shixiang Zheng

Ting Wei

Lixuan Wei

Zhendong Li

Jinhuai Xue

Guowen Wang

Youhua Zhu

Bugela

Huarong Zhao

yuankai shi

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 .

The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors

Single-arm, Open, Multi-center Phase I/Phase II Clinical Study to Assess the Safety, Tolerability, Pharmacokinetic and Effectiveness of VC004

Adverse events (CTCAE5.0)and/or laboratory testsand/or electrocardiogramand/or echocardiogramand/or vital signsand/or physical examination

According to the tolerability and pharmacokinetic results of different dose groups completed during the dose escalation phase, an appropriate dose or MTD is selected as RP2D

If ≥2 cases of DLT are observed at a certain dose (up to 6 subjects), the dose will be considered an intolerable dose, and the previous dose group will be regarded as MTD

The proportion of subjects whose best overall response is CR or PR in the study assessed by IRC/investigator according to RECIST v1.1 or RANO

Time from the first recording of remission (CR or PR) to the first recording of disease progression or death (whichever occurs first)

The time from the subject receiving the first study treatment to the appearance of disease progression or death from any cause (whichever occurs first)

The time from the date of first medication to the date of death from any cause

Jiangsu vcare pharmaceutical technology co., LTD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors	NCT04614740	Locally Advance... Metastatic Soli...	VC004	18 Years -	Jiangsu vcare pharmaceutical technology co., LTD
The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors	NCT04614740	Locally Advance... Metastatic Soli...	VC004	18 Years -	Jiangsu vcare pharmaceutical technology co., LTD

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