Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

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

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

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

TAS3351 oral administration

Taiho Oncology, Inc

Kim Chul

Melissa Johnson

Xiuning Le

Alexander Spira

David Planchard

Juergen Wolf

Giuseppe Curigliano

Koichi Goto

Haruyasu Murakami

Uchibori Ken

Kim Tae Min

Lee Dae Ho

Gerrina Ruiter

Egbert Smit

Enriqueta Felip Font

Luis Paz-Ares Rodriguez

Yvonne Summers

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.

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.

A Study of TAS3351 in NSCLC Patients With EGFRmt

A Phase 1/2 Study of TAS3351 in Patients With Advanced Non-Small Cell Lung Cancer and EGFR Mutations

Incidence of dose limiting toxicities (DLTs)

Evaluate the maximum plasma concentration (Cmax)

Area under the plasma concentration-time curve (AUC)

Objective Response Rate (ORR) by Investigator Assessment

Duration of Response (DoR) by Investigator Assessment

Progression Free Survival (PFS) by Investigator Assessment

Disease Control Rate (DCR) by Investigator Assessment

Intracranial Objective Response Rate (icORR)

Intracranial Duration of Response (icDOR)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of TAS3351 in NSCLC Patients With EGFRmt	NCT05765734	Non-Small Cell ...	TAS3351 oral ad...	18 Years -	Taiho Oncology, Inc.
A Study of TAS3351 in NSCLC Patients With EGFRmt	NCT05765734	Non-Small Cell ...	TAS3351 oral ad...	18 Years -	Taiho Oncology, Inc.

Spots Global Cancer Trial Database for tas3351

Every month we try and update this database with for tas3351 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tas3351

Every month we try and update this database with for tas3351 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tas3351 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.