NCT06046495RecruitingPhase 1
A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
A Phase I Open-label, Multi-dose, Dose Escalation and Dose Expansion Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 23 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 81 (estimated)
- First submitted
- 6 Sept 2023
- Start date
- 8 Jul 2024
- Primary completion date
- 9 Feb 2028
- Lead sponsor
- Avistone Biotechnology Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT06046495
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 81
- From 8 Jul 2024 to the primary completion date, 9 Feb 2028
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received radiotherapy within 14 days before enrollment;
- Have used other experimental drugs within 2 weeks prior to the first dose of PLB1004;
Other illness
- 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;
- Have any condition or illness that could affect the compliance with the protocol.
Other
- Pregnant or lactating women;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| - Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Nebraska Cancer Specialists Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| University of California - Davis Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Swedish Health Sciences Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.