A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
- Registration Number
- NCT06046495
- Lead Sponsor
- Avistone Biotechnology Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 81
- Ability to understand and willingness to sign a written informed consent document;
- Male or female adult patients 18 years of age or older;
- Patients should have recovered from toxicities related to prior anti-tumor therapy;
- Patients should have recovered from the effects of major surgery;
- Have a documented EGFR mutation by a local test in tissue or plasma;
- At least 12 weeks life expectancy;
- Must have at least one measurable lesion per RECIST v 1.1;
- Sexually active males and females of childbearing potential must agree to take effective contraceptive measures.
- Received radiotherapy within 14 days before enrollment;
- Have significant or uncontrolled systemic disease;
- Have significant or uncontrolled cardiovascular disease;
- Have had other diagnosed malignant diseases that required treatment within the past 3 years besides NSCLC;
- Currently have or had a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia that requires steroid therapy;
- Have known hypersensitivity to the similar drugs and excipients of PLB1004;
- Pregnant or lactating women;
- Have used other experimental drugs within 2 weeks prior to the first dose of PLB1004;
- Have any condition or illness that could affect the compliance with the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description PLB1004 PLB1004 PLB1004 given as a mono-therapy in dose escalation and dose expansion phase.
- Primary Outcome Measures
Name Time Method Safety profile of PLB1004 per CTCAE v5.0 Up to 2 years
- Secondary Outcome Measures
Name Time Method Disease Control Rate (DCR) Up to 3 years Overall Survival (OS) Up to 3 years Time to maximum plasma concentration (Tmax) of PLB1004 Approximately 28 days. Change from baseline in corrected QT interval (QTc) using Fridericia formula (QTcF) Up to 3 years Overall Response Rate (ORR) Up to 3 years Progression-Free Survival (PFS) Up to 3 years To define the DLTs and MTD Up to 3 years Area Under the Curve (AUC) of PLB1004 Approximately 28 days. Maximum plasma concentration (Cmax) of PLB1004 Approximately 28 days. Duration of Response (DOR) Up to 3 years
Trial Locations
- Locations (5)
University of California-Davis
🇺🇸Sacramento, California, United States
Research Site
🇺🇸Seattle, Washington, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Swedish Health Sciences
🇺🇸Seattle, Washington, United States