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NCT06631989

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

StatusActive, Not Recruiting
PhasePhase 1/2
Primary completion (estimated)
Track this trial

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 31 words Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 60 participants (planned 100)
    • Trial arms changed: 3 → 2
    • Site details revised at 12 of 12 sites
  2. Primary completion date: Jun 30, 2026 to Jun 30, 2027v2 Show 7 more changesShow less
    • Eligibility criteria shortened, about 585 words
    • Primary endpoints revised (5)
    • Study sites: 1 to 12
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    • Start date: Aug 21, 2024 to Sep 4, 2024
    • Secondary endpoints: 36 to 27
    • Study description expanded, about 13 words
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

ORR by IRC
Timeframe: every 6 weeks, up to 1 year
PartA: To evaluate the safety of WSD0922-FU in patients with NSCLC
Timeframe: 8 months
PartA: To evaluate the tolerability of WSD0922-FU in patients with NSCLC
Timeframe: 8 months
PartA: To evaluate the Maximum Tolerated Dose (MTD) of WSD0922-FU in patients with NSCLC
Timeframe: 8 months
PartA: Recommended Phase II Dose (RP2D) of WSD0922-FU in patients with NSCLC
Timeframe: 8 months

Secondary (27)

PK exposure parameter: Maximum Plasma Concentration (Cmax)
PK exposure parameter: Time To Maximum Plasma Concentration (Tmax)
PK exposure parameter: Area Under The Plasma Concentration-Time Curve From Time Zero To Time With Last Measurable Concentration (AUC0-t)
PK exposure parameter: Area Under The Plasma Concentration-Time Curve From Time Zero To Infinity (AUC0-∞)
PK exposure parameter: Terminal Elimination Half-Life (t½)
Show 22 moreShow less
PK exposure parameter: Apparent Terminal Elimination Rate Constant (λz)
PK exposure parameter: Apparent Clearance (CL)
PK exposure parameter: Apparent volume of distribution (Vd)
PK exposure parameter: Mean Residence Time (MRT)
Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve（AUCss）
Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve from 0 to Infinity（AUC0-∞,ss）
Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve from 0 to Time t （AUC0-t,ss）
Steady state pharmacokinetic parameter: Average Steady-State Concentration（Cav）
Steady state pharmacokinetic parameter: Steady-State Clearance（CLss）
PK exposure parameter :Maximum Steady-State Concentration（Cmax,ss）
PK exposure parameter : Minimum Steady-State Concentration（Cmin,ss）
PK exposure parameter : Trough Concentration（Ctrough）
PK exposure parameter : Fluctuation Degree（DF）
PK exposure parameter : Accumulation Ratio（Ra）
PK exposure parameter : Time to Maximum Concentration at Steady State（Tmax,ss）
PK exposure parameter : Volume of Distribution Calculated from the Terminal Elimination Phase（Vz）
To evaluate the safety of WSD0922-FU in patients with advanced non-small cell lung cancer
ORR by investigators
Disease Control Rate (DCR)
Duration of Response (DoR)
PFS
OS

Arms and interventions

Dose escalation (WSD0922-FU)Experimental

Patients receive WSD0922-FU PO QD on C0D1 to C0D3, then BID on C1D1 to C1D21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study.

Dose expansion (WSD0922-FU)Experimental

Patients receive WSD0922-FU PO BID on C1D1 to C1D21 using dosage selected from Dose escalation. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study.

Drugs: WSD0922-FU

Sites

12 sites in 1 country