A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer

NCT06631989 | Recruiting Phase 1

• 1 other identifier: WSD0922-102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 12

Brief 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 .

Conditions

EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer

Keywords

NSCLC; EGFR; C797S; BM

Outcome Measures

Primary Outcomes (5)

• ORR by IRC

  proportion of patients with a best overall response of complete response or partial response

  every 6 weeks, up to 1 year

• 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

Secondary Outcomes (27)

• PK exposure parameter: Maximum Plasma Concentration (Cmax)

  12 months

• PK exposure parameter: 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)

  12 months

• PK exposure parameter: Area Under The Plasma Concentration-Time Curve From Time Zero To Infinity (AUC0-∞)

  12 months

• PK exposure parameter: Terminal Elimination Half-Life (t½)

  12 months

Study Arms (3)

Dose escalation (WSD0922-FU)

EXPERIMENTAL

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

Dose expansion (WSD0922-FU)

EXPERIMENTAL

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

Dose extension (WSD0922-FU)

EXPERIMENTAL

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

Interventions

WSD0922-FU DRUG

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

Also known as: WSD0922

Dose escalation (WSD0922-FU); Dose expansion (WSD0922-FU); Dose extension (WSD0922-FU)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wayshine Biopharm, Inc.: lead

Study Sites (12)

Anhui Provincial Hospital

Hefei, Anhui, 230031, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510062, China

RECRUITING

He'nan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Sichuan Provincial Cancer Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300202, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 317000, China

RECRUITING

Study Officials

• Caicun Zhou, MD

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lily liu, MD

CONTACT

+8613818880308; lily.liu@wayshinebiopharm.com

Wei Zhong, PhD

CONTACT

1-951-547-4692; wei.zhong@wayshinebiopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A (Dose escalation and expansion study) ; Part B (single-arm extension study).

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: October 8, 2024
• Study Start: September 4, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)