Trial Title:
A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients with EGFRm+ Advanced Non-small Cell Lung Cancer
NCT ID:
NCT06631989
Condition:
EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
NSCLC
EGFR
C797S
BM
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Part A (Dose escalation and expansion study) ; Part B (single-arm extension study).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
WSD0922-FU
Description:
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
Arm group label:
Dose escalation (WSD0922-FU)
Arm group label:
Dose expansion (WSD0922-FU)
Arm group label:
Dose extension (WSD0922-FU)
Summary:
This study is a multicenter, open label, single-arm phase I/II clinical study of
WSD0922-FU conducted in China, including Part A (dose escalation and expansion study) and
Part B (dose extension). To explore the safety, tolerability, pharmacokinetic
characteristics and efficacy of WSD0922-FU in patients with non-small cell lung cancer
(NSCLC) with C797S mutation after first-line third-generation EGFR-TKI resistance
(Osimertinib, Almonertinib, Furmonertinib, Befotertinib).
Detailed description:
A multicenter, open label, single-arm phase I/II clinical study of WSD0922-FU conducted
in China.
To explore the safety, tolerability, pharmacokinetic characteristics and efficacy of
WSD0922-FU in patients with non-small cell lung cancer (NSCLC) with C797S mutation after
first-line third-generation EGFR-TKI resistance.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years old (including the threshold value), gender is not limited;
2. Locally advanced or metastatic NSCLC confirmed by pathology;
3. Patients who have been genetically tested to carry EGFR C797S sensitive mutations
(including deletion mutations in exon 19 and L858R point mutations in exon 21) and
have disease progression during or after previous first-line therapy with
third-generation EGFR-TKI (Osimertinib, Almonertinib, Furmonertinib, Befotertinib)
inhibitors;
4. Blood samples must be provided for testing and must be taken during or after disease
progression following the last EGFR TKI inhibitor treatment; Test results from the
last treatment of previous EGFR TKI inhibitors (not limited to blood samples) are
acceptable;
5. Must have a minimum life expectancy of >= 3 months;
6. 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.
7. Physical Status (ECOG PS) score of the Eastern United States Tumor Collaboration
Group was 0-1;
8. Have full organ function:
1. Blood system (has not received blood transfusion or hematopoietic stimulating
factor treatment within 14 days prior to the first dose) :
- Absolute neutrophil count (ANC) ≥1.5×10^9/L;
- Platelet (PLT) count ≥100×10^9/L;
- Hemoglobin (HB) ≥90g/L;
2. Liver function:
- Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN);
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤3×ULN
(AST and ALT≤5×ULN in patients with liver metastasis);
3. Kidney function:
- Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Ccr)
≥60ml/min/1.73m2 (Cockcroft-Gault formula, creatinine >1.5×ULN only);
4. Coagulation function:
- Activated partial thromboplastin time (APTT) ≤1.5×ULN;
- International Standardized ratio (INR) ≤1.5×ULN;
9. Eligible patients (male and female) who are fertile must agree to use a reliable
contraceptive method (hormonal or barrier method or abstinence) with their partner
during the trial period and for at least 90 days after the last dose; Blood
pregnancy tests (β-HCG) must be negative for female subjects of reproductive age
within 7 days prior to the first use of the study drug;
10. Subjects are required to give informed consent to this study before the experiment
and sign a written informed consent voluntarily.
Exclusion Criteria:
1. 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, except for the following:
1. Oral fluoropyrimidine class and small molecule targeted drugs are within 2
weeks before the first use of the study drug or within 5 half-lives of the drug
(whichever is shorter);
2. Chinese medicine with anti-tumor indications is within 2 weeks before the first
use of the study drug;
2. Have previously received more than one EGFR-TKI inhibitor;
3. Received other unlisted clinical study drugs or treatments within 4 weeks before the
first administration;
4. 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;
5. Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the
first use of the study drug;
6. Known to carry any other known driver gene mutations (including but not limited to
T790M, EGFR exon 20 insertion, KRAS, BRAF V600E, NTRK1/2/3, HER2, ALK, ROS1, MET, or
RET);
7. Known active brain metastasis or progression evidence. Active brain metastasis
refers to malignant central nervous system (CNS) metastasis diagnosed by enhanced
MRI/CT, excluding brain abscesses, cerebrovascular diseases, and other diseases, and
showing new neurological abnormalities such as headache, vomiting, vision
impairment, mental abnormalities, language disorders, unilateral limb sensory
abnormalities or weakness, olfactory hallucinations, hemiplegia, or staggering gait,
tinnitus, or deafness. Within 14 days before the first administration of the study
drug, palliative radiotherapy or radiosurgery for brain metastases, or the need for
more than 10 mg/day of prednisone or equivalent glucocorticoids. Subjects with
treated, stable brain metastases or untreated asymptomatic brain metastases are
allowed to enroll;
8. Known intracranial hemorrhage and/or bleeding diathesis;
9. Other primary malignant tumors within 2 years before the first administration of the
study drug. Limited cured tumors such as basal cell carcinoma of the skin, squamous
cell carcinoma of the skin, superficial bladder cancer, prostatic intraepithelial
cancer, cervical intraepithelial cancer, and breast intraepithelial cancer are
excluded;
10. 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);
11. Skin/pressure ulcers, chronic leg ulcers, known active gastric ulcers, or
non-healing wounds;
12. History of severe allergies, or allergies to any active or inactive ingredients of
the study drug;
13. Severe infections requiring intravenous antibiotic infusion or hospitalization at
the time of screening; or uncontrollable active infections within 4 weeks before
administration;
14. Known active or suspected autoimmune diseases; or known active ocular diseases (such
as active wet age-related macular degeneration, diabetic retinopathy with macular
edema);
15. Human immunodeficiency virus (HIV) (HIV1/2 antibody) positive, syphilis spirochete
antibody positive (those who are syphilis spirochete antibody positive need to
undergo a confirmatory test, and those who are negative in the confirmatory test can
be included), active hepatitis B (HBsAg positive and HBV-DNA>1000 IU or research
center detection limit [only when the research center detection limit is higher than
1000 IU/mL]); active hepatitis C (HCV antibody positive but HCV-RNA < research
center detection limit patients are allowed to be included);
16. Patients with interstitial lung disease;
17. History of severe cardiovascular diseases, including but not limited to:
1. Severe cardiac rhythm or conduction abnormalities, such as clinically
interventional ventricular arrhythmias, second to third-degree atrioventricular
block; corrected QTcF interval for males >450 milliseconds, for females >470
milliseconds;
2. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke,
or other grade 3 or above cardiovascular and cerebrovascular events within 6
months before the first administration;
3. American New York Heart Association (NYHA) heart function classification ≥II or
left ventricular ejection fraction (LVEF) ≤50%;
4. Clinically uncontrollable hypertension (specifically systolic blood pressure
≥150mmHg and/or diastolic blood pressure ≥100mmHg);
18. Unable to orally swallow medication, or there is a condition that significantly
affects gastrointestinal absorption as judged by the researcher;
19. 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),
pericardial effusion (excluding a small amount of pericardial effusion that has been
stable for more than 2 weeks);
20. Known alcohol or drug dependence;
21. Mental disorders or poor compliance;
22. Pregnant or lactating women;
23. The investigator believes that the subject has other reasons that make them
unsuitable for participating in this clinical study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200123
Country:
China
Status:
Recruiting
Contact:
Last name:
Anwen Xiong, MD
Contact backup:
Last name:
Caicun Zhou, MD
Start date:
August 21, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Wayshine Biopharm, Inc.
Agency class:
Industry
Source:
Wayshine Biopharm, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06631989
