Actively Recruiting
A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
Led by Avistone Biotechnology Co., Ltd. · Updated on 2025-04-23
81
Participants Needed
7
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to sign informed consent
- Male or female adult patients 18 years or older
- Recovered from toxicities of prior anti-tumor therapy
- Recovered from effects of major surgery
- Documented EGFR mutation in tissue or plasma
- At least 12 weeks life expectancy
- At least one measurable lesion per RECIST v 1.1
- Sexually active males and females of childbearing potential agree to use effective contraception
You will not qualify if you...
- Received radiotherapy within 14 days before enrollment
- Significant or uncontrolled systemic disease
- Significant or uncontrolled cardiovascular disease
- Other malignancies requiring treatment within past 3 years except NSCLC
- Current or history of interstitial lung disease or radiation pneumonia requiring steroid therapy
- Known hypersensitivity to PLB1004 or similar drugs
- Pregnant or lactating women
- Used other experimental drugs within 2 weeks prior to first dose
- Any condition that could affect compliance with the protocol
AI-Screening
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Trial Site Locations
Total: 7 locations
1
University of California-Davis
Sacramento, California, United States, 95817-1514
Actively Recruiting
2
Research Site
Louisville, Kentucky, United States, 40202
Actively Recruiting
3
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
4
Research Site
New York, New York, United States, 100021
Actively Recruiting
5
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
6
Swedish Health Sciences
Seattle, Washington, United States, 98122
Actively Recruiting
7
Research Site
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
A
Avistone Clinical Study Information Center Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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