A Phase 1 Study of PLB1004 in People With Non-Small Cell Lung Cancer

Share

Full Title

A Phase 1 Open-label, Multi-dose, Dose Escalation and Dose Expansion Study of the Oral EGFR inhibitor PLB1004 in Non-Small Cell Lung Cancer

Purpose

Researchers want to find the best dose of PLB1004 to use in people with non-small cell lung cancer (NSCLC). The people in this study have NSCLC that has a mutation in a gene called EGFR. In addition, their cancer cannot be cured using standard therapies.

PLB1004 targets specific EGFR mutations which can lead to uncontrolled cell growth. These include mutations called exon 20 insertions, exon 18 mutations, and other uncommon mutations. There are no available treatments after standard therapies have failed that target specific EGFR mutations the way PLB1004 does. PLB1004 is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have stage 3B or 4 NSCLC that cannot be cured with standard treatments and has a specific EGFR mutation.
  • Have recovered from the serious side effects of prior treatments before taking PLB1004.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Helena Yu’s office at 646-608-3912.

Protocol

24-319

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06046495