A Phase 1/2 Study of TAS3351 in Patients With Advanced Non-Small Cell Lung Cancer and EGFR Mutations
Status: Terminated
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Washington, D.c.
Georgetown University - Lombardi Comprehensive Cancer Center
Washington D.c.
Tennessee
Tennessee Oncology
Nashville
Texas
University of Texas M. D. Anderson Cancer Center
Houston
Virginia
Next Oncology - Virginia
Fairfax
Other Locations
France
Institut Gustave Roussy
Villejuif
Germany
Universitaetsklinikum Koeln
Cologne
Italy
IEO Istituto Europeo di Oncologia
Milan
Japan
National Cancer Center Hospital East
Kashiwa-shi
Cancer Institute Hospital of JFCR
Kōtoku
Shizuoka Cancer Center
Sunto-gun
Netherlands
Antoni van Leeuwenhoek
Amsterdam
Leiden University Medical Center (LUMC)
Leiden
Republic of Korea
Asan Medical Center
Seoul
Seoul National University Hospital
Seoul
Spain
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Universitario 12 de Octubre
Madrid
United Kingdom
The Christie Hospital
Manchester
Time Frame
Start Date: 2023-05-25
Completion Date: 2025-03-14
Participants
Target number of participants: 18
Treatments
Experimental: TAS3351 Part A (Dose Escalation)
Dose escalation will assess the safety and determine the recommended phase 2 dose and regimen of TAS3351 administered orally.
Experimental: TAS3351 Part B (Dose Expansion)
TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose determined in Part A.
Experimental: TAS3351 Part C (Phase 2)
To assess efficacy of TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose.
Related Therapeutic Areas
Sponsors
Leads: Taiho Oncology, Inc.