A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

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

Trial Details

NCT ID
NCT06046495
Phase
PHASE1
Sponsor
Avistone Biotechnology Co., Ltd.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • PLB1004
Locations (sample)
  • Sacramento, California, United States|38.58157,-121.4944
  • Louisville, Kentucky, United States|38.25424,-85.75941
  • Omaha, Nebraska, United States|41.25626,-95.94043
  • New York, New York, United States|40.71427,-74.00597
  • Nashville, Tennessee, United States|36.16589,-86.78444

Key Eligibility 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;

For full eligibility, visit ClinicalTrials.gov.

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