NCT06046495 · Avistone Biotechnology Co., Ltd.
A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
What this study is about
This is a Phase I, conducted at multiple hospitals, where both patients and doctors know the treatment given, gradually increasing doses and dose expansion study to assess the safety and how the drug moves through the body 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 gradually increasing doses into 7 cohorts and patient allocation to these cohorts will be via slot allocation. Each group of participants has a minimum of 3 and a maximum of 6 patients for a total of 21 - 42 patients. The patient population of the gradually increasing doses 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Sacramento, California
- Louisville, Kentucky
- Omaha, Nebraska
- New York, New York
- Nashville, Tennessee
- Seattle, Washington
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2025 · Source of record for eligibility and locations