A Dose-escalation, Dose-extension and Efficacy-extension, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of AP-L1898 Capsule for the Treatment of the Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Overview
- Phase
- Phase 1
- Intervention
- JS111(AP-L1898 Capsules)
- Conditions
- Lung Cancer
- Sponsor
- Suzhou Junjing BioSciences Co., Ltd.
- Enrollment
- 156
- Locations
- 37
- Primary Endpoint
- ORR
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
40mg dose.
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
Intervention: JS111(AP-L1898 Capsules)
80mg dose.
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
Intervention: JS111(AP-L1898 Capsules)
160mg dose.
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
Intervention: JS111(AP-L1898 Capsules)
240mg dose.
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
Intervention: JS111(AP-L1898 Capsules)
320mg dose.
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
Intervention: JS111(AP-L1898 Capsules)
Outcomes
Primary Outcomes
ORR
Time Frame: up to 3 years
The ORR summary will be calculated.
Safety assessed by the ophthalmic examination
Time Frame: up to 3 years
The ophthalmic examination summary will be provided.
Safety assessed by the ECOG score
Time Frame: up to 3 years
The worsening ECOG score summary will be provided.
Safety assessed by the adverse event
Time Frame: up to 3 years
The AEs summary will be provided.
Safety assessed by the serious adverse event
Time Frame: up to 3 years
The SAEs summary will be provided.
Safety assessed by the physical examinatin
Time Frame: up to 3 years
The abnormal physical examinatin summary will be provided.
Secondary Outcomes
- Vd/F(up to 3 years)
- Tmax(up to 3 years)
- AUC 0-t(up to 3 years)
- Cmax(0up to 3 years)
- OS(up to 3 years)
- t1/2(up to 3 years)
- CL/F(up to 3 years)
- DoR(up to 3 years)
- DCR(up to 3 years)
- Plasma drug concentration after administration of study drug(up to 3 years)