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

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 .

Study Overview

• Status: Recruiting
• Conditions: EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: WSD0922-FU

Detailed Description

WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ and dual EGFRm+/C797S+ receptor forms of EGFR with selectivity margin over wild-type EGFR. This study aims 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: lily Liu, MD; Phone Number: +8613818880308; Email: lily.liu@wayshinebiopharm.com
• Study Contact Backup: Name: Wei Zhong, PhD; Phone Number: 1-951-547-4692; Email: wei.zhong@wayshinebiopharm.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230031
      • Recruiting
      • Anhui Provincial Hospital
      • Contact: Principal Investigator; Phone Number: 86-551-65327766; Email: yueyinpan1965@126.com
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Principal Investigator; Phone Number: 86-10-67781331; Email: jie_969@163.com
  • Guangdong
    • Guangzhou, Guangdong, China, 510062
      • Recruiting
      • The First Affiliated Hospital, Sun Yat-sen University
      • Contact: Principal Investigator; Phone Number: 86-20-87331952; Email: tangkejing@163.com
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • He'nan Cancer Hospital
      • Contact: Principal Investigator; Phone Number: 86-371-65861505; Email: 13938252350@163.com
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital
      • Contact: Principal Investigator; Phone Number: 86-531-87984777; Email: xinglg@medmail.com.cn
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Principal Investigator; Phone Number: 86-21-62821990; Email: eddiedong8@hotmail.com
    • Shanghai, Shanghai Municipality, China, 200123
      • Recruiting
      • Shanghai East Hospital
      • Principal Investigator: Caicun zhou, MD
      • Contact: Anwen Xiong, MD
    • Shanghai, Shanghai Municipality, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Principal Investigator; Phone Number: 02165115006; Email: fywu@163.com
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Sichuan Provincial Cancer Hospital
      • Contact: Principal Investigator; Phone Number: 86-28-85420305; Email: dr.lijuan@hotmail.com
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300202
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Principal Investigator; Phone Number: 02223353454; Email: dingzhih72@163.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Principal Investigator; Phone Number: 86 -571-87236697; Email: zjyalcyj@sina.com
    • Taizhou, Zhejiang, China, 317000
      • Recruiting
      • Taizhou Hospital of Zhejiang Province
      • Contact: Principal Investigator; Phone Number: 86-576-85112241; Email: lvdq855@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: WSD0922-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; Other Names: WSD0922
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.	Drug: WSD0922-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; Other Names: WSD0922
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.	Drug: WSD0922-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; Other Names: WSD0922

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PartA: To evaluate the safety of WSD0922-FU in patients with NSCLC	Safety (incidence and severity of adverse events [AE])	8 months
PartA: To evaluate the tolerability of WSD0922-FU in patients with NSCLC	Incidence and quantity of dose-limiting toxicity (DLT)	8 months
PartA: To evaluate the Maximum Tolerated Dose (MTD) of WSD0922-FU in patients with NSCLC	Incidence of Dose-Limiting Toxicities (DLTs)	8 months
PartA: Recommended Phase II Dose (RP2D) of WSD0922-FU in patients with NSCLC	Recommended Phase II Dose (RP2D)	8 months
ORR by IRC	proportion of patients with a best overall response of complete response or partial response	every 6 weeks, up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK exposure parameter: Maximum Plasma Concentration (Cmax)	Maximum Plasma Concentration (Cmax)	12 months
PK exposure parameter: Time To Maximum Plasma Concentration (Tmax)	Time To Maximum Plasma Concentration (Tmax)	12 months
PK exposure parameter: Area Under The Plasma Concentration-Time Curve From Time Zero To Time With Last Measurable Concentration (AUC0-t)	Area Under The Plasma Concentration-Time Curve From Time Zero To Time With Last Measurable Concentration (AUC0-t)	12 months
PK exposure parameter: Area Under The Plasma Concentration-Time Curve From Time Zero To Infinity (AUC0-∞)	Area Under The Plasma Concentration-Time Curve From Time Zero To Infinity (AUC0-∞)	12 months
PK exposure parameter: Terminal Elimination Half-Life (t½)	Terminal Elimination Half-Life (t½)	12 months
PK exposure parameter: Apparent Terminal Elimination Rate Constant (λz)	Apparent Terminal Elimination Rate Constant (λz)	12 months
PK exposure parameter: Apparent Clearance (CL)	Apparent Clearance (CL)	12 months
PK exposure parameter: Apparent volume of distribution (Vd)	Apparent volume of distribution (Vd)	12 months
PK exposure parameter: Mean Residence Time (MRT)	Mean Residence Time (MRT)	12 months
Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve（AUCss）	Area Under the Steady-State Concentration-Time Curve（AUCss）	12 months
Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve from 0 to Infinity（AUC0-∞,ss）	Area Under the Steady-State Concentration-Time Curve from 0 to Infinity（AUC0-∞,ss）	12 months
Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve from 0 to Time t （AUC0-t,ss）	Area Under the Steady-State Concentration-Time Curve from 0 to Time t （AUC0-t,ss）	12 months
Steady state pharmacokinetic parameter: Average Steady-State Concentration（Cav）	Average Steady-State Concentration（Cav）	12 months
Steady state pharmacokinetic parameter: Steady-State Clearance（CLss）	Steady-State Clearance（CLss）	12 months
PK exposure parameter :Maximum Steady-State Concentration（Cmax,ss）	Maximum Steady-State Concentration（Cmax,ss）	12 months
PK exposure parameter : Minimum Steady-State Concentration（Cmin,ss）	Minimum Steady-State Concentration（Cmin,ss）	12 months
PK exposure parameter : Trough Concentration（Ctrough）	Trough Concentration（Ctrough）	12 months
PK exposure parameter : Fluctuation Degree（DF）	Fluctuation Degree（DF）	12 months
PK exposure parameter : Accumulation Ratio（Ra）	Accumulation Ratio（Ra）	12 months
PK exposure parameter : Time to Maximum Concentration at Steady State（Tmax,ss）	Time to Maximum Concentration at Steady State（Tmax,ss）	12 months
PK exposure parameter : Volume of Distribution Calculated from the Terminal Elimination Phase（Vz）	Volume of Distribution Calculated from the Terminal Elimination Phase（Vz）	12 months
To evaluate the safety of WSD0922-FU in patients with advanced non-small cell lung cancer	Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs)	12 months
ORR by investigators	proportion of patients with a best overall response of complete response or partial response	every 6 week, up to 12 months
Disease Control Rate (DCR)	the percentage of patients who have a best overall response of CR or PR or SD	every 6 weeks, up to12 months
Duration of Response (DoR)	proportion of patients with the time from the date of first documented response until the date of documented progression or death in the absence of disease progression	every 6 weeks, up to 12 months
PFS	proportion of patients with the time from randomization until the date of objective disease progression or death	every 6 weeks, up to 12 months
OS	proportion of patients with the time from randomization until the date of objective disease progression or death	24 months

Collaborators and Investigators

• Sponsor: Wayshine Biopharm, Inc.
• Investigators: Principal Investigator: Caicun Zhou, MD, Shanghai East Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 25, 2024
• First Submitted That Met QC Criteria: October 5, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: NSCLC; EGFR; BM; C797S
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: WSD0922-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No