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REACH-EGFRNCT07699328

A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 3 versions: 2 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 42 words
    • Study completion pushed from Jan 1, 2029 to Oct 1, 2029
    • Secondary endpoints: details revised at 3 of 20 entries
    • Site details revised at 3 of 29 sites
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Estimate of Maximum Tolerated Dose (MTD) of VRN110755
Timeframe: 28 days
Number of participants with dose-limiting toxicities (DLTs) following treatment with VRN110755
Timeframe: 28 days
Number of participants experiencing treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation
Timeframe: From first dose until end of study (up to approximately 6 years)
Number of participants with changes in vital signs from baseline following treatment with VRN110755
Timeframe: From baseline through End of Treatment (up to approximately 6 years)
Number of participants with changes in laboratory test results from baseline following treatment with VRN110755
Timeframe: From baseline through End of Treatment (up to approximately 6 years)
Number of participants with changes in physical examination findings from baseline following treatment with VRN110755
Timeframe: From baseline through End of Treatment (up to approximately 6 years)
Number of participants with changes in ophthalmologic examination findings from baseline following treatment with VRN110755
Timeframe: From baseline through End of Treatment (up to approximately 6 years)
Number of participants with changes in electrocardiogram (ECG) parameters from baseline following treatment with VRN110755
Timeframe: From baseline through End of Treatment (up to approximately 6 years)
Number of participants with changes in Eastern Cooperative Oncology Group (ECOG) Performance Status from baseline following treatment with VRN110755
Timeframe: From baseline through End of Treatment (up to approximately 6 years)

Secondary (20)

Plasma PK of VRN110755 - Maximum Plasma Concentration (Cmax)
Plasma PK of VRN110755 - Minimum Plasma Concentration (Cmin)
Plasma PK of VRN110755 - Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast)
Plasma PK of VRN110755 - Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCτ)
Plasma PK of VRN110755 - Time to Maximum Plasma Concentration (Tmax)
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Plasma PK of VRN110755 - Terminal Elimination Rate Constant (λz)
Plasma PK of VRN110755 - Apparent Terminal Elimination Half-life (t½)
Plasma PK of VRN110755 - Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Plasma PK of VRN110755 - Apparent Total Plasma Clearance (CL/F)
Plasma PK of VRN110755 - Trough Plasma Concentration (Ctrough)
Plasma PK of VRN110755 - Mean Residence Time Based on AUClast (MRTlast)
Plasma PK of VRN110755 - Accumulation Ratio (Rac)
Change from Baseline in Circulating Tumor DNA (ctDNA)
Objective Response Rate (ORR)
Duration of Response (DOR)
Number of participants with Disease Control Rate (DCR)
Progression-Free Survival (PFS)
Overall Survival (OS)
Intracranial Objective Response Rate (Intracranial ORR)
Intracranial Progression-Free Survival (Intracranial PFS)

Arms and interventions

Phase 1a Dose EscalationExperimental

Participants with advanced, metastatic, or recurrent EGFR-mutant non-small cell lung cancer (NSCLC) who have experienced disease progression following prior EGFR tyrosine kinase inhibitor (TKI) therapy and harbor activating, resistant, uncommon, or complex EGFR mutations. Participants receive escalating dose levels of VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity and to determine the maximum tolerated dose (MTD).

Phase 1b Cohort AExperimental

Participants with EGFR-mutant NSCLC harboring exon 19 deletion or exon 21 L858R mutations and a C797X resistance mutation following progression on first-line third-generation EGFR TKI therapy, including osimertinib, lazertinib, or aumolertinib. Participants receive VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity and to support selection of the recommended Phase 2 dose.

Phase 1b Cohort BExperimental

Treatment-naïve participants with NSCLC harboring common EGFR mutations. Participants receive VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity in patients who have not previously received systemic treatment for EGFR-mutant NSCLC.

Phase 1b Cohort CExperimental

Participants with NSCLC harboring atypical or uncommon EGFR mutations, including G719X, L861Q, S768I, E709X, R776H, L747S, or combinations thereof, who have previously received at least one prior systemic therapy, including an EGFR TKI, and have no remaining standard treatment options expected to provide clinical benefit. Participants receive VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity.

Phase 1b Cohort DExperimental

Treatment-naïve participants with NSCLC harboring atypical EGFR mutations. Participants receive VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity in patients who have not previously received systemic treatment for EGFR-mutant NSCLC.

Drugs: VRN110755

Sites

29 sites in 10 countries

South Korea 5, Taiwan 5, Malaysia 4, Spain 4, Australia 2, France 2, Hong Kong 2, Singapore 2, Thailand 2, Canada 1