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

Phase 2RecruitingNCT06631989

Wayshine Biopharm, Inc.100 enrolled

Overview

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 .

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer

Interventions

WSD0922-FUDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (12)

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

ORR by IRC

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

Time frame: 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 \[AE\])

Time frame: 8 months

PartA: To evaluate the tolerability of WSD0922-FU in patients with NSCLC

Incidence and quantity of dose-limiting toxicity (DLT)

Time frame: 8 months

PartA: To evaluate the Maximum Tolerated Dose (MTD) of WSD0922-FU in patients with NSCLC

Incidence of Dose-Limiting Toxicities (DLTs)

Time frame: 8 months

PartA: Recommended Phase II Dose (RP2D) of WSD0922-FU in patients with NSCLC

Recommended Phase II Dose (RP2D)

Time frame: 8 months

Secondary Outcomes

PK exposure parameter: Maximum Plasma Concentration (Cmax)

Maximum Plasma Concentration (Cmax)

Time frame: 12 months

PK exposure parameter: Time To Maximum Plasma Concentration (Tmax)

Time To Maximum Plasma Concentration (Tmax)

Time frame: 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)

Central Contacts

lily liu, MD

CONTACT

+8613818880308 lily.liu@wayshinebiopharm.com

Wei Zhong, PhD

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

He'nan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Sichuan Provincial Cancer Hospital

Chengdu, Sichuan, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

...and 2 more locations

Time frame: 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-∞)

Time frame: 12 months

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

Terminal Elimination Half-Life (t½)

Time frame: 12 months

PK exposure parameter: Apparent Terminal Elimination Rate Constant (λz)

Apparent Terminal Elimination Rate Constant (λz)

Time frame: 12 months

PK exposure parameter: Apparent Clearance (CL)

Apparent Clearance (CL)

Time frame: 12 months

PK exposure parameter: Apparent volume of distribution (Vd)

Apparent volume of distribution (Vd)

Time frame: 12 months

PK exposure parameter: Mean Residence Time (MRT)

Mean Residence Time (MRT)

Time frame: 12 months

Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve（AUCss）

Area Under the Steady-State Concentration-Time Curve（AUCss）

Time frame: 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）

Time frame: 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）

Time frame: 12 months

Steady state pharmacokinetic parameter: Average Steady-State Concentration（Cav）

Average Steady-State Concentration（Cav）

Time frame: 12 months

Steady state pharmacokinetic parameter: Steady-State Clearance（CLss）

Steady-State Clearance（CLss）

Time frame: 12 months

PK exposure parameter :Maximum Steady-State Concentration（Cmax,ss）

Maximum Steady-State Concentration（Cmax,ss）

Time frame: 12 months

PK exposure parameter : Minimum Steady-State Concentration（Cmin,ss）

Minimum Steady-State Concentration（Cmin,ss）

Time frame: 12 months

PK exposure parameter : Trough Concentration（Ctrough）

Trough Concentration（Ctrough）

Time frame: 12 months

PK exposure parameter : Fluctuation Degree（DF）

Fluctuation Degree（DF）

Time frame: 12 months

PK exposure parameter : Accumulation Ratio（Ra）

Accumulation Ratio（Ra）

Time frame: 12 months

PK exposure parameter : Time to Maximum Concentration at Steady State（Tmax,ss）

Time to Maximum Concentration at Steady State（Tmax,ss）

Time frame: 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）

Time frame: 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)

Time frame: 12 months

ORR by investigators

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: every 6 weeks, up to 12 months

proportion of patients with the time from randomization until the date of objective disease progression or death

Time frame: 24 months