Clinical Trials /

A Study of ZN-e4 in Subjects With Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer

NCT03446417

Description:

This is a Phase I, open-label, multicenter, sequential dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-e4 administered orally in subjects with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations who have progressed following treatment with an EGFR inhibitor.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of ZN-e4 in Subjects With Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer
  • Official Title: A Phase 1 Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of ZN-e4 in Patients With Advanced Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor (EGFR) Mutations

Clinical Trial IDs

  • ORG STUDY ID: ZN-e4-001
  • NCT ID: NCT03446417

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DrugSynonymsArms
ZN-e4Dose escalation

Purpose

This is a Phase I, open-label, multicenter, sequential dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-e4 administered orally in subjects with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations who have progressed following treatment with an EGFR inhibitor.

Trial Arms

NameTypeDescriptionInterventions
Dose escalationExperimentalUp to 6 sequential dose escalation cohorts until maximum tolerated dose or recommended phase 2 dose is identified
  • ZN-e4
Dose expansionExperimentalZN-e4 in subjects with T790M mutation in epidermal growth factor receptor (EGFR) gene.
  • ZN-e4

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Histologically or cytologically confirmed metastatic or advanced inoperable diagnosis
             of non-small cell lung cancer (NSCLC)

          -  Radiographic documentation of disease progression while on previous continuous
             treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor
             (TKI)

          -  All subjects must fulfill one of the following:

               1. Confirmation that the tumor harbors an EGFR mutation known to be associated with
                  EGFR TKI sensitivity OR

               2. Must have experienced clinical benefit from EGFR TKI, according to the Jackman
                  criteria followed by systemic objective progression while on continuous treatment
                  with EGFR TKI

          -  Dose Expansion cohort(s): subjects in the dose expansion cohorts must also have
             confirmation of tumor T790M mutation status (confirmed positive) by cobas® EGFR
             Mutation Test v2 from formalin-fixed paraffin-embedded tumor tissue (FFPET) or
             circulating-free tumor DNA (cfDNA) plasma sample taken after disease progression on
             the most recent treatment regimen (EGFR TKI or chemotherapy or other therapy).

        Exclusion Criteria:

          -  Treatment with an EGFR TKI within 10 days or 5 half-lives of the first dose of study
             treatment, whichever is longer

          -  Dose Expansion cohorts: Prior treatment with osimertinib (Tagrisso®). Prior treatment
             with osimertinib (Tagrisso®) is allowed for subjects participating in the dose
             escalation portion of the study

          -  Cytotoxic chemotherapy, investigational agents, or any anticancer therapy for the
             treatment of advanced NSCLC (other than EGFR TKI) within 21 days of the first dose of
             study treatment

          -  Prior treatment with immunotherapy (e.g. ipilimumab, nivolumab, pembrolizumab,
             atezolizumab) within 6 months of cycle 1 day 1

          -  Known intermediate or strong CYP3A4 or CYP2C8 inhibitors or inducers within 14 days
             prior to first dose of study treatment
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Observed dose limiting toxicities
Time Frame:1 Cycle (21 days)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Safety and tolerability as measured by incidence of treatment emergent adverse events
Time Frame:Through study completion, approximately 2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Zeno Pharmaceuticals, Inc.

Last Updated

February 22, 2018