A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer - Trial NCT06046495
Access comprehensive clinical trial information for NCT06046495 through Pure Global AI's free database. This Phase 1 trial is sponsored by Avistone Biotechnology Co., Ltd. and is currently Not yet recruiting. The study focuses on Non-Small Cell Lung Cancer. Target enrollment is 82 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Avistone Biotechnology Co., Ltd.
Timeline & Enrollment
Phase 1
Sep 29, 2023
Feb 09, 2028
Primary Outcome
Safety profile of PLB1004 per CTCAE v5.0
Summary
This is a Phase I, multicenter, open-label, dose escalation and dose expansion study to
 assess the safety and pharmacokinetic profile of PLB1004, a mono-anilino-pyrimidine compound,
 given alone in NSCLC patients with EGFR exon 20 insertion mutations. Patients will be
 enrolled and dosed according to the most current protocol. This study is made of two Parts.
 Part 1 includes a dose escalation into 7 cohorts and patient allocation to these cohorts will
 be via slot allocation. Each cohort has a minimum of 3 and a maximum of 6 patients for a
 total of 21 - 42 patients. Part 2 includes an expansion phase and patient allocation to two
 dose levels with 20 patients per cohort.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06046495
Non-Device Trial