RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-07-01

Study Completion:2028-02-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06046495

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Avistone Clinical Study Information Center Center

CONTACT

+86-10-84148921

information.center@avistonebio.com

Study Locations (Sites)

University of California-Davis

Sacramento, California, 95817-1514

United States

Nebraska Cancer Specialists

Omaha, Nebraska, 68130

United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

United States

Swedish Health Sciences

Seattle, Washington, 98122

United States

Collaborators and Investigators

Sponsor: Avistone Biotechnology Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01

Study Completion Date2028-02-09

Study Record Updates

Study Start Date2024-07-01

Study Completion Date2028-02-09

Terms related to this study

Additional Relevant MeSH Terms

Non-Small Cell Lung Cancer