Health TrialsbyHealthPanel

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

ConditionEGFR Mutation Positive Advanced Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWayshine Biopharm, Inc.

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Dose escalation (WSD0922-FU)Experimental treatment 1 intervention
Group B: Dose expansion (WSD0922-FU)Experimental treatment 1 intervention
Group C: Dose extension (WSD0922-FU)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Safety (incidence and severity of adverse events \[AE\])

Time frame
8 months
3

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

Incidence and quantity of dose-limiting toxicity (DLT)

Time frame
8 months
4

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

Secondary outcomes

1

PK exposure parameter: Maximum Plasma Concentration (Cmax)

Maximum Plasma Concentration (Cmax)

Time frame
12 months
2

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

Time To Maximum Plasma Concentration (Tmax)

Time frame
12 months
3

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)

Time frame
12 months
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wayshine Biopharm, Inc.

Lead sponsor

Source ClinicalTrials.gov
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