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

Wayshine Biopharm, Inc.

Status and phase

Enrolling

Phase 2

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: WSD0922-FU Tablets, Dose level A

Drug: WSD0922-FU Tablets, Dose level B

Study type

Interventional

Funder types

Industry

Identifiers

NCT06868485

WS2202

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Dose level A selected from Phase I study

Experimental group

Description:

BID

Treatment:

Drug: WSD0922-FU Tablets, Dose level A

Dose level B selected from Phase I study

Experimental group

Description:

BID

Treatment:

Drug: WSD0922-FU Tablets, Dose level B

Trial contacts and locations

Central trial contact

Wei Zhong; Carina Yu

Data sourced from clinicaltrials.gov

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