A Study of TAS3351 in NSCLC Patients With EGFRmt

• Status: Not yet recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Oncology, Inc.

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