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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
PLB1004 will be orally self-administered by the patient as a mono-therapy.
University of California-Davis
Sacramento, California, United States
RECRUITINGResearch Site
Louisville, Kentucky, United States
RECRUITINGNebraska Cancer Specialists
Omaha, Nebraska, United States
RECRUITINGResearch Site
New York, New York, United States
RECRUITINGSarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGSwedish Health Sciences
Seattle, Washington, United States
RECRUITINGResearch Site
Seattle, Washington, United States
RECRUITINGSafety profile of PLB1004 per CTCAE v5.0
Time frame: Up to 2 years
To define the DLTs and MTD
Time frame: Up to 3 years
Area Under the Curve (AUC) of PLB1004
Time frame: Approximately 28 days.
Maximum plasma concentration (Cmax) of PLB1004
Time frame: Approximately 28 days.
Time to maximum plasma concentration (Tmax) of PLB1004
Time frame: Approximately 28 days.
Overall Response Rate (ORR)
Time frame: Up to 3 years
Progression-Free Survival (PFS)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
Disease Control Rate (DCR)
Time frame: Up to 3 years
Duration of Response (DOR)
Time frame: Up to 3 years
Change from baseline in corrected QT interval (QTc) using Fridericia formula (QTcF)
Time frame: Up to 3 years
Avistone Clinical Study Information Center Center
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