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

NCT ID: NCT06046495

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-08
• Study Completion Date: 2028-02-09

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PLB1004

PLB1004 given as a mono-therapy in dose escalation and dose expansion phase.

Group Type: EXPERIMENTAL

PLB1004

Intervention Type: DRUG

PLB1004 will be orally self-administered by the patient as a mono-therapy.

Interventions

PLB1004

PLB1004 will be orally self-administered by the patient as a mono-therapy.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avistone Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California-Davis

Sacramento, California, United States

Site Status: RECRUITING

Research Site

Louisville, Kentucky, United States

Site Status: RECRUITING

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Site Status: RECRUITING

Research Site

New York, New York, United States

Site Status: RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status: RECRUITING

Swedish Health Sciences

Seattle, Washington, United States

Site Status: RECRUITING

Research Site

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Avistone Clinical Study Information Center Center

Role: CONTACT

information.center@avistonebio.com

+86-10-84148921

Facility Contacts

Study Director, MD

Role: primary

Study Director, MD

Role: primary

Study Director, MD

Role: primary

Study Director, MD

Role: primary

Other Identifiers

PLB1004-I-US01

Identifier Type: -

Identifier Source: org_study_id