Overview
This is a first-in-human, open label, Phase 1/2 study to investigate the safety and efficacy of TAS3351 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.
Description
This study will be conducted in 3 parts (i.e. dose escalation, dose expansion, and a phase 2 portion). The dose escalation part will investigate the safety and determine the recommended phase 2 dose and the recommended dosing regimen of TAS3351 administered orally. The dose expansion part will explore the efficacy of TAS3351 in NSCLC patients with C797S EGFR mutations. The phase 2 part will assess the efficacy of TAS3351 in NSCLC patients with C797S EGFR mutations.
Eligibility
Inclusion Criteria:
- Locally advanced, non-resectable or metastatic NSCLC
- Have adequate organ function
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Has tumor tissue available to allow for analysis of EGFRmt status
Dose Escalation:
• Has any EGFRmt status
Dose Escalation back-fill part, Dose Expansion and Phase II:
- Has any sensitizing EGFRmt and a confirmed C797S EGFRmt
- Has measurable disease per RECIST v1.1
Exclusion Criteria:
- Participating in medical research not compatible with this study
- Symptomatic and unstable CNS metastases
- Have not recovered from prior cancer treatment
- Have a significant cardiac condition
- Are a pregnant or breastfeeding female
- A serious illness or medical condition
- Unable to swallow or digest pills