AP-L1898 Capsule in Patients With Non-small Cell Lung Cancer

Phase 1

• 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

Study Timeline

• Study First Submitted: 2021-06-10
• Study Start: 2021-07-13
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Primary Completion: 2024-06-18
• Study Completion: 2024-08-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

Not provided

Exclusion Criteria

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)
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.
t1/2	up to 3 years	Elimination half life time
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.
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.
Cmax	0up to 3 years	observed maximum plasma concentration of AP-L1898
DCR	up to 3 years	the proportion of subjects with CR, PR or SD as the best response in accordance with RECIST1.1.

Trial Locations

Locations (37)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Chinese People's Liberation Army Army Characteristic Medical Center; 🇨🇳 Chongqing, Chongqing, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

Sun Yat-sen Memorial Hospital ], Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Cancer Hospital Chinese Academy of Medical Sciences，Shenzhen center; 🇨🇳 Shenzhen, Guangdong, China

Affiliated Hospital of Guangdong Medical University; 🇨🇳 Zhanjiang, Guangdong, China

Liuzhou People's Hospital; 🇨🇳 Liuzhou, Guangxi, China

Harbin Medical University Cancer Hospital; 🇨🇳 Haerbin, Heilongjiang, China

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