Clinical Trial of YH25448 in Patients with EGFR Mutation Positive Advanced NSCLC

Sponsor
Yuhan Corporation
Study ID
NCT03046992
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • EGFR Gene Mutation

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • YH25448 — DRUG
    * Dose Escalation: YH25448 20mg\~320mg, PO * Dose Expansion: YH25448 40mg\~240mg, PO * Dose Extension: Recommended Dose 240mg of YH25448

Study Details

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.

Key Dates

Start date
Feb 15, 2017
Status verified
Apr 2023
Primary completion
Jan 8, 2021
Completion
Mar 30, 2023

Study Design

Enrollment
224 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: YH25448
    * Dose Escalation Phase: Consists of 7 Cohorts * Dose Expansion Phase: Consists of 5 Cohorts * Dose Extension Phase: Consists of 2 Cohorts

Primary Outcome Measure

Safety and tolerability by Common Terminology Criteria for Adverse Events (CTCAE) v4.03 [ Time Frame: Safety and tolerability profile will be collected from baseline until 28 days after the last dose, expected average 1 year. ]

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