RecruitingPhase 1NCT06046495

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

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

Sponsor

Avistone Biotechnology Co., Ltd.

Enrollment

81 participants

Start Date

Jul 8, 2024

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral drug called PLB1004 for patients with non-small cell lung cancer (NSCLC) that has a specific EGFR mutation — a genetic change that drives tumor growth. Unlike intravenous drugs, this medication is taken by mouth, which may be more convenient for patients. **You may be eligible if...** - You are 18 or older - You have non-small cell lung cancer with a confirmed EGFR mutation (in a tumor or blood test) - You have recovered from side effects of prior cancer treatments - You have at least one tumor that can be measured on a scan - You have at least 12 weeks of life expectancy **You may NOT be eligible if...** - You have had radiation within 14 days of starting the study - You have uncontrolled heart or other serious systemic diseases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.