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
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Sichuan Provincial Cancer Hospital
RECRUITING
Chengdu
The First Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
Shandong Cancer Hospital
RECRUITING
Jinan
Shanghai Chest Hospital
RECRUITING
Shanghai
Shanghai East Hospital
RECRUITING
Shanghai
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Taizhou Hospital of Zhejiang Province
RECRUITING
Taizhou
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
He'nan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
lily liu, MD
lily.liu@wayshinebiopharm.com
+8613818880308
Backup
Wei Zhong, PhD
wei.zhong@wayshinebiopharm.com
1-951-547-4692
Time Frame
Start Date:2024-09-04
Estimated Completion Date:2027-12-31
Participants
Target number of participants:100
Treatments
Experimental: Dose escalation (WSD0922-FU)
Patients receive WSD0922-FU PO QD on C0D1 to C0D3, then BID on C1D1 to C1D21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study.
Experimental: Dose expansion (WSD0922-FU)
Patients receive WSD0922-FU PO BID on C1D1 to C1D21 using dosage selected from Dose escalation. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study.
Experimental: Dose extension (WSD0922-FU)
Patients receive WSD0922-FU PO BID on C1D1 to C1D21 using RP2D. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study.