Testing PLB1004 for 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

This study is testing a new oral medication for people with non-small cell lung cancer to see how safe it is and how well it works for those with certain genetic changes.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Avistone Biotechnology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 7 sites (Sacramento, California and 6 other locations)
• Trial ID: NCT06046495 on ClinicalTrials.gov

What this trial studies

This Phase I, multicenter, open-label study evaluates the safety and pharmacokinetics of PLB1004, an oral EGFR inhibitor, in patients with non-small cell lung cancer (NSCLC) harboring various EGFR mutations. The study consists of two parts: a dose escalation phase with 7 cohorts to determine the optimal dosing and a dose expansion phase focusing on patients with specific EGFR exon 20 insertion mutations. Participants will be closely monitored for safety and treatment response as they receive the medication according to the study protocol.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced NSCLC and documented EGFR mutations.

Not a fit: Patients with significant uncontrolled systemic diseases or those who have received recent radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with specific EGFR mutations in NSCLC.

How similar studies have performed: Other studies have shown promise with similar EGFR-targeted therapies, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Where this trial is running

Sacramento, California and 6 other locations

• University of California-Davis — Sacramento, California, United States (Recruiting)
• Research Site — Louisville, Kentucky, United States (Recruiting)
• Nebraska Cancer Specialists — Omaha, Nebraska, United States (Recruiting)
• Research Site — New York, New York, United States (Recruiting)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (Recruiting)
• Swedish Health Sciences — Seattle, Washington, United States (Recruiting)
• Research Site — Seattle, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Avistone Clinical Study Information Center Center

Conditions Non-Small Cell Lung Cancer