Assessing WSD0922-FU for advanced lung cancer with specific mutations

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 testing a new treatment called WSD0922-FU for patients in China with advanced lung cancer who have a specific mutation and haven't responded to standard therapies.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Wayshine Biopharm, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 12 sites (Hefei, Anhui and 11 other locations)
• Trial ID: NCT06631989 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, single-arm phase I/II clinical study evaluates the safety, tolerability, pharmacokinetics, and efficacy of WSD0922-FU in patients with advanced non-small cell lung cancer (NSCLC) who have the C797S mutation and have experienced resistance to first-line third-generation EGFR-TKI therapies. The study is conducted in China and consists of two parts: a dose escalation and expansion study, followed by a dose extension phase. Participants will receive WSD0922-FU and will be monitored for treatment outcomes and side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced NSCLC confirmed by pathology and carrying the EGFR C797S mutation after progression on third-generation EGFR-TKIs.

Not a fit: Patients without the EGFR C797S mutation or those who have not progressed after first-line EGFR-TKI therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced NSCLC who have developed resistance to existing EGFR-TKI therapies.

How similar studies have performed: While there have been studies on EGFR mutations and targeted therapies, this specific approach with WSD0922-FU in the context of C797S mutation resistance is novel.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 11 other locations

• Anhui Provincial Hospital — Hefei, Anhui, China (Recruiting)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
• 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)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Caicun Zhou, MD — Shanghai East Hospital
• Study coordinator: lily liu, MD

Conditions EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer; NSCLC; EGFR; C797S; BM