A Study of TAS3351 in NSCLC Patients With EGFRmt

Taiho Pharma

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: TAS3351 oral administration

Study type: Interventional

Funder types: Industry

Identifiers

NCT05765734

2022-502595-23 (EudraCT Number)

10073010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

TAS3351 Part A (Dose Escalation)

Experimental group

Description:

Dose escalation will assess the safety and determine the recommended phase 2 dose and regimen of TAS3351 administered orally.

Treatment:

Drug: TAS3351 oral administration

TAS3351 Part B (Dose Expansion)

Experimental group

Description:

TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose determined in Part A.

Treatment:

Drug: TAS3351 oral administration

TAS3351 Part C (Phase 2)

Experimental group

Description:

To assess efficacy of TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose.

Treatment:

Drug: TAS3351 oral administration