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40mg dose. for Lung Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Suzhou Junjing BioSciences Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
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.
Eligible Conditions
- Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ORR
Safety assessed by the ECOG score
Safety assessed by the adverse event
+3 moreSecondary outcome measures
AUC 0-t
CL/F
Cmax
+7 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: 80mg dose.Experimental Treatment1 Intervention
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
Group II: 40mg dose.Experimental Treatment1 Intervention
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
Group III: 320mg dose.Experimental Treatment1 Intervention
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
Group IV: 240mg dose.Experimental Treatment1 Intervention
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
Group V: 160mg dose.Experimental Treatment1 Intervention
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
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Who is running the clinical trial?
Suzhou Junjing BioSciences Co., Ltd.Lead Sponsor
4 Previous Clinical Trials
361 Total Patients Enrolled
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