A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
Start Date
7/8/2024
Completion Date
2/9/2028
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,uncommon mutations, classical mutations (Ex19del and L858R), and drug-resistant mutation (T790M). 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. The patient population of the dose escalation phase will include patients with advanced NSCLC harboring EGFR classical mutations or Ex20ins mutations, or uncommon mutations. Part 2 includes an expansion phase and the expansion phase will explore one or more dose levels of PLB1004 in NSCLC patients with EGFR Ex20ins mutations, classical mutations, or uncommon mutations.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
PLB1004
Conditions
Locations
University of California-Davis
Sacramento, California 95817-1514
United States
Research Site
Louisville, Kentucky 40202
United States
Nebraska Cancer Specialists
Omaha, Nebraska 68130
United States
Research Site
New York, New York 100021
United States
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Swedish Health Sciences
Seattle, Washington 98122
United States
Research Site
Seattle, Washington 98195
United States