A Study to Assess the Efficacy of WSD0922-FU in Patients with C797S+ Advanced Non-small Cell Lung Cancer

Sponsor: Wayshine Biopharm, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06868485

This Phase II study evaluates WSD0922-FU, a reversible EGFR inhibitor, in advanced NSCLC patients post-Osimertinib treatment. Eligible participants are adults with confirmed NSCLC, ECOG 0-1, and documented EGFR mutation. Interventions include oral WSD0922-FU tablets, administered in 21-day cycles at two dose levels.

Patient Parameters

Program Overview

This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.

Description

WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ (TKI sensitivity conferring mutation) and dual EGFRm+/C797S+ (third-generation TKI as first-line resistance conferring mutation) receptor forms of EGFR with selectivity margin over wild-type EGFR. Therefore WSD0922-FU has the potential to provide clinical benefit to patients with advanced NSCLC harboring both the single sensitivity mutations and the resistance mutation following first-line therapy with a third-generation EGFR TKI (e.g., Osimertinib). The clinical development program with WSD0922-FU will assess the safety and efficacy of WSD0922-FU in patients with advanced NSCLC whose cancers have progressed with or without brain metastasis following a first-line Osimertinib treatment.

Eligibility Criteria

Inclusion Criteria

  • Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
  • Male or female aged ≥18 years old.
  • Histological or cytological confirmation diagnosis of NSCLC.
  • Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
  • Evidence of radiological disease progression while on a previous continuous treatment with first-line Osimertinib treatment.
  • Documented EGFR mutation .
  • Eastern Cooperative Oncology Group (ECOG) 0-1 and a minimum life expectancy of 12 weeks.
  • At least one lesion, not previously irradiated and not chosen for biopsy during the study.
  • Females should have evidence of non-childbearing potential.

Exclusion Criteria

  • Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
  • Any unresolved toxicities from prior therapy greater than CTCAE Grade 1.
  • Symptomatic brain complications that require urgent neurosurgical or medical intervention.
  • Any evidence of severe or uncontrolled systemic diseases.
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
  • Past medical history of ILD.
  • Inadequate bone marrow reserve or organ function as demonstrated.
  • Males and females of reproductive potential.
  • Known intracranial hemorrhage which is unrelated to tumor.
  • Seizures requiring a change in anti-epileptic medications.

Locations

FACILITYZIPCITYSTATE
Cleveland Clinic44195ClevelandOhio

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