A Study of TAS3351 in NSCLC Patients With EGFRmt

Sponsor: Taiho Oncology, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05765734

Provider View

This Phase 1/2 study evaluates TAS3351's safety and efficacy in advanced NSCLC with C797S EGFR mutations. It includes dose escalation to determine optimal dosing, followed by dose expansion and Phase 2 to assess efficacy. Eligible patients have advanced NSCLC, adequate organ function, and specific EGFR mutations. TAS3351 is administered orally.

Patient Parameters

Program 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 Criteria

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

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