A Phase 1/2 Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of ZN-e4 (KP-673) in Patients With Advanced Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor (EGFR) Mutations
Overview
- Phase
- Phase 1
- Intervention
- ZN-e4
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Zeno Pharmaceuticals, Inc.
- Enrollment
- 34
- Locations
- 7
- Primary Endpoint
- Observed dose limiting toxicities
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a Phase 1/2, open-label, multicenter, sequential dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-e4 administered orally in subjects with advanced non-small cell lung cancer (NSCLC) with activating EGFR mutations who have progressed while on treatment with an EGFR tyrosine kinase inhibitor (TKI) agent (other lines of treatment are allowed, except for other epidermal growth factor receptor inhibitors [EGFRis]) for Phase 1; and for Phase 2, subjects who have T790M+ and are osimertinib naïve (Cohort 1), and also those who have not been treated with an EGFR Inhibitor (EGFRi) (Cohort2).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Phase 1
Up to 9 sequential dose escalation cohorts to determine maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified.
Intervention: ZN-e4
Phase 2
MTD/RP2D in subjects: Cohort 1: with T790M mutation in epidermal growth factor receptor (EGFR) gene, and are osimertinib naïve. Cohort 2: EGFRm amenable to EGFR inhibitor therapy (eg, exon 19 del, L858R) and who have never been treated with EGFRis.
Intervention: ZN-e4
Outcomes
Primary Outcomes
Observed dose limiting toxicities
Time Frame: 1 Cycle (21 days)
Secondary Outcomes
- Safety and tolerability as measured by incidence of treatment emergent adverse events(Through study completion, approximately 2 years)