AP-L1898 Capsule in Patients With Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Drug: JS111(AP-L1898 Capsules)
- Registration Number
- NCT04993391
- Lead Sponsor
- Suzhou Junjing BioSciences Co., Ltd.
- Brief Summary
This is a phase I/II, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS111 for patients with Non-small cell lung cance. This study is divided into 3 periods: dose escalation stage, dose extension stage, and efficacy extension stage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 156
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 40mg dose. JS111(AP-L1898 Capsules) The subjects will receive a single dose at first in this stage, and be observed for 7 days subsequently, if tolerated, the subjects will enter the multi-dose study on oral AP-L1898 once per day for consecutive 21 days. The DLT observational per 320mg dose. JS111(AP-L1898 Capsules) The subjects will receive a single dose at first in this stage, and be observed for 7 days subsequently, if tolerated, the subjects will enter the multi-dose study on oral AP-L1898 once per day for consecutive 21 days. The DLT observational pe 80mg dose. JS111(AP-L1898 Capsules) The subjects will receive a single dose at first in this stage, and be observed for 7 days subsequently, if tolerated, the subjects will enter the multi-dose study on oral AP-L1898 once per day for consecutive 21 days. The DLT observational per 160mg dose. JS111(AP-L1898 Capsules) The subjects will receive a single dose at first in this stage, and be observed for 7 days subsequently, if tolerated, the subjects will enter the multi-dose study on oral AP-L1898 once per day for consecutive 21 days. The DLT observational pe 240mg dose. JS111(AP-L1898 Capsules) The subjects will receive a single dose at first in this stage, and be observed for 7 days subsequently, if tolerated, the subjects will enter the multi-dose study on oral AP-L1898 once per day for consecutive 21 days. The DLT observational pe
- Primary Outcome Measures
Name Time Method Safety assessed by the ophthalmic examination up to 3 years The ophthalmic examination summary will be provided.
Safety assessed by the ECOG score up to 3 years The worsening ECOG score summary will be provided.
Safety assessed by the adverse event up to 3 years The AEs summary will be provided.
Safety assessed by the serious adverse event up to 3 years The SAEs summary will be provided.
Safety assessed by the physical examinatin up to 3 years The abnormal physical examinatin summary will be provided.
ORR up to 3 years The ORR summary will be calculated.
- Secondary Outcome Measures
Name Time Method AUC 0-t up to 3 years Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC 0-t)
Cmax 0up to 3 years observed maximum plasma concentration of AP-L1898
Vd/F up to 3 years Apparent volume of distribution (Vd/F)
OS up to 3 years Kaplan-Meimer method will be used to plot survival curve, while the median survival will be calculated.
CL/F up to 3 years apparent clearance (CL/F)
Tmax up to 3 years time ro reach maximum plasam concentration of AP-L1898
DoR up to 3 years the time from the first evaluation of CR or PR to the first evaluation of PD or death for any reason. For the subjects who have no progression but survive persistently after meeting the response criteria, the duration of response will be censored on the date of the last evaluable tumor evaluation or the last follow-up of progression of disease.
DCR up to 3 years the proportion of subjects with CR, PR or SD as the best response in accordance with RECIST1.1.
Plasma drug concentration after administration of study drug up to 3 years The actual date and time of collection of each PK sample (24h system, accurate to minute) will be recorded in the study. Except an accurate record of the actual time point for collection of PK sample, the administration also needs to be recorded to evaluate PK data. The plasma concentrations of AP-L1898 and its metabolites will be determined using validated LC-MS/MS method.
t1/2 up to 3 years Elimination half life time
Trial Locations
- Locations (37)
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Liuzhou People's Hospital
🇨🇳Liuzhou, Guangxi, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
North Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Sun Yat-sen Memorial Hospital ], Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Affiliated Hospital of Guangdong Medical University
🇨🇳Zhanjiang, Guangdong, China
Harbin Medical University Cancer Hospital
🇨🇳Haerbin, Heilongjiang, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
🇨🇳Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Huhehaote, Neimenggu, China
Liaoning Cancer Hospital
🇨🇳Shenyang, Liaoning, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Weifang People's Hospital
🇨🇳Weifang, Shandong, China
Shanghai Oriental Hospital
🇨🇳Shanghai, Shanghai, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
Hangzhou Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital , Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
Hunan Cancer Hospital
🇨🇳Changsha, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Chinese People's Liberation Army Army Characteristic Medical Center
🇨🇳Chongqing, Chongqing, China
Cancer Hospital Chinese Academy of Medical Sciences，Shenzhen center
🇨🇳Shenzhen, Guangdong, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China