Status:
RECRUITING
A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
Lead Sponsor:
Avistone Biotechnology Co., Ltd.
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 NSC...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 9 2028
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT06046495
Start Date
July 8 2024
End Date
February 9 2028
Last Update
April 23 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California-Davis
Sacramento, California, United States, 95817-1514
2
Research Site
Louisville, Kentucky, United States, 40202
3
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
4
Research Site
New York, New York, United States, 100021