RecruitingPhase 1Phase 2NCT06631989
A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer
A Phase I/II Multicenter, Open Label, Single-arm Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of WSD0922-FU in the Treatment of Advanced Non-small Cell Lung Cancer
Sponsor
Wayshine Biopharm, Inc.
Enrollment
100 participants
Start Date
Sep 4, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This study is a multicenter, open label, single-arm phase I/II clinical trial of WSD0922-FU for patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed with thrid-generation EGFR-TKI .
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria10
- Age 18-75 years old (including the threshold value), gender is not limited;
- Locally advanced or metastatic NSCLC confirmed by pathology;
- Patients who have been genetically tested to carry EGFR sensitive mutations;
- Blood samples must be provided for testing and must be taken during or after disease progression following the last EGFR TKI inhibitor treatment;
- Must have a minimum life expectancy of \>= 3 months;
- At least one measurable tumor lesion according to RECIST version 1.1; Previous radiotherapy-treated lesions cannot be used as target lesions unless imaging studies show clear progression of the lesions.
- Physical Status (ECOG PS) score was 0-1;
- Have full organ function;
- Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method ;
- Subjects are required to give informed consent to this study before the experiment and sign a written informed consent voluntarily.
Exclusion Criteria21
- Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug.
- Have previously received more than one EGFR-TKI inhibitor;
- Received other unlisted clinical study drugs or treatments within 4 weeks before the first administration.
- Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period.
- Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drug.
- Known active brain metastasis or progression evidence.
- Other primary malignant tumors within 2 years before the first administration of the study drug.
- Adverse reactions from previous anti-tumor treatments have not recovered to NCI-CTCAE v5.0 grade ≤1 (except for toxicities judged by the researcher to have no safety risks, such as hair loss, grade 2 peripheral neurotoxicity, and stable thyroid function after hormone replacement therapy).
- Skin/pressure ulcers, chronic leg ulcers, known active gastric ulcers, or non-healing wounds.
- History of severe allergies, or allergies to any active or inactive ingredients of the study drug;
- Severe infections requiring intravenous antibiotic infusion or hospitalization at the time of screening; or uncontrollable active infections within 4 weeks before administration;
- Known active or suspected autoimmune diseases; or known active ocular diseases (such as active wet age-related macular degeneration, diabetic retinopathy with macular edema);
- Human immunodeficiency virus (HIV) (HIV1/2 antibody) positive, syphilis spirochete antibody positive .
- Patients with interstitial lung disease.
- History of severe cardiovascular diseases.
- Unable to orally swallow medication, or there is a condition that significantly affects gastrointestinal absorption as judged by the researcher;
- Clinical intervention is required for pleural effusion, ascites (excluding subjects who do not need drainage and have been stable for more than 2 weeks after drainage).
- Known alcohol or drug dependence.
- Mental disorders or poor compliance;
- Pregnant or lactating women;
- The investigator believes that the subject has other reasons that make them unsuitable for participating in this clinical study.
Interventions
DRUGWSD0922-FU
Procedure: Biospecimen Collection - blood samples Undergo collection of blood samples Procedure: Computed Tomography and/or Magnetic Resonance Imaging Undergo CT and/or MRI Drug: WSD0922-FU Given PO
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT06631989