Spots Global Cancer Trial Database for Clinical Trial of YH25448 in Patients With EGFR Mutation Positive Advanced NSCLC
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Trial Identification
Brief Title: Clinical Trial of YH25448 in Patients With EGFR Mutation Positive Advanced NSCLC
Official Title: A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients With EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT03046992
Conditions
Interventions
Study Description
Brief Summary: YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR. YH25448 is expected to beneficial for the NSCLC patients with brain metastasis due to good blood brain barrier (BBB) penetration property as well as for the treatment of primary lung lesion and extracranial lesions. This study will be conducted to evaluate the safety, tolerability and efficacy of YH25448 in locally advanced or metastatic NSCLC patients with EGFR mutations.
Detailed Description: This is a first time in patient study primarily designed to evaluate the safety, tolerability, and efficacy of YH25448 in in patients with EGFR mutation positive (EGFRm+) advanced NSCLC with or without asymptomatic brain metastasis who progressed following prior therapy with an EGFR TKIs agent. This study is composed of 3 parts; part A is a dose escalation phase, part B is a dose expansion phase and part C is a dose extension phase. In dose escalation phase, YH25448 will be escalated to reach either a maximum tolerated or absorbable dose in patients as defined by dose-limiting toxicity in NSCLC patients who progressed following prior EGFR TKIs treatment to evaluate the safety and tolerability. In dose expansion phase, further safety, tolerability, pharmacokinetic(PK) and efficacy will be evaluated at each dose level(s) of dose escalation phase in NSCLC patients who progressed following prior EGFR TKIs treatment and harbouring confirmed T790M mutation. In dose extension phase, additional 2 cohorts (2nd line therapy cohort, 1st line therapy cohort) will be enrolled to further assess the efficacy, safety, tolerability, and PK of YH25448 at the maximum tolerated dose (MTD) or recommended dose (RD) defined through dose escalation phase and dose expansion phase. Results of these studies will serve as the evidence for further clinical development. This study will also characterize the metabolite(s) profile of YH25448 and determine PK of its metabolite(s) in biological samples if necessary. Also, exploratory correlation between biomarker profiles and pharmacokinetics/pharmacodynamics will be analyzed.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do, Korea, Republic of
The Catholic University of Korea, Bucheon St. Mary's Hospital, Bucheon-si, Gyeonggi-do, Korea, Republic of
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
CHA Bundang Medical Center, CHA University, Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital, Suwon-si, Gyeonggi-do, Korea, Republic of
Gyeongsang National University Hospital, Jinju-si, Gyeongsangnam-do, Korea, Republic of
Inje University Haeundae Paik Hospital, Busan, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Kangbuk Samsung Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
SMG-SNU Boramae Medical Center, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
Contact Details
Name: Yuhan Corporation
Affiliation: Clinical Development Department
Role: STUDY_DIRECTOR
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