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

a study on Lung Cancer Non-Small Cell Lung Cancer Lung Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

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 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.

Official Title

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

Keywords

Non-Small Cell Lung Cancer, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, PLB1004

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Ability to understand and willingness to sign a written informed consent document;
  2. Male or female adult patients 18 years of age or older;
  3. Patients should have recovered from toxicities related to prior anti-tumor therapy;
  4. Patients should have recovered from the effects of major surgery;
  5. Have a documented EGFR mutation by a local test in tissue or plasma;
  6. At least 12 weeks life expectancy;
  7. Must have at least one measurable lesion per RECIST v 1.1;
  8. Sexually active males and females of childbearing potential must agree to take effective contraceptive measures.

You CAN'T join if...

  1. Received radiotherapy within 14 days before enrollment;
  2. Have significant or uncontrolled systemic disease;
  3. Have significant or uncontrolled cardiovascular disease;
  4. Have had other diagnosed malignant diseases that required treatment within the past 3 years besides NSCLC;
  5. Currently have or had a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia that requires steroid therapy;
  6. Have known hypersensitivity to the similar drugs and excipients of PLB1004;
  7. Pregnant or lactating women;
  8. Have used other experimental drugs within 2 weeks prior to the first dose of PLB1004;
  9. Have any condition or illness that could affect the compliance with the protocol.

Locations

  • University of California-Davis accepting new patients
    Sacramento California 95817-1514 United States
  • Swedish Health Sciences accepting new patients
    Seattle Washington 98122 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Avistone Biotechnology Co., Ltd.
ID
NCT06046495
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 81 study participants
Last Updated