Trial Title:
A Study of TAS3351 in NSCLC Patients With EGFRmt
NCT ID:
NCT05765734
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Non-Small Cell Lung Cancer
NSCLC
EGFR mutation
C797S mutation
TAS3351
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TAS3351 oral administration
Description:
TAS3351 will be administered orally
Arm group label:
TAS3351 Part A (Dose Escalation)
Arm group label:
TAS3351 Part B (Dose Expansion)
Arm group label:
TAS3351 Part C (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.
Detailed 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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Georgetown University - Lombardi Comprehensive Cancer Center
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Withdrawn
Facility:
Name:
Tennessee Oncology
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Phone:
615-329-7274
Email:
mjohnson@tnonc.com
Investigator:
Last name:
Melissa Johnson
Email:
Principal Investigator
Facility:
Name:
University of Texas M. D. Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Phone:
713-792-6363
Email:
xle1@mdanderson.org
Investigator:
Last name:
Xiuning Le
Email:
Principal Investigator
Facility:
Name:
Next Oncology - Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Phone:
703-280-5390
Email:
aspira@nextoncology.com
Investigator:
Last name:
Alexander Spira
Email:
Principal Investigator
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif cedex
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Phone:
+33549444444
Email:
david.planchard@gustaveroussy.fr
Investigator:
Last name:
David Planchard
Email:
Principal Investigator
Facility:
Name:
Universitaetsklinikum Koeln
Address:
City:
Koeln
Zip:
50937
Country:
Germany
Status:
Recruiting
Contact:
Phone:
+4922147889050
Email:
juergen.wolf@uk-koeln.de
Investigator:
Last name:
Juergen Wolf
Email:
Principal Investigator
Facility:
Name:
IEO Istituto Europeo di Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Not yet recruiting
Contact:
Phone:
390257489599
Email:
giuseppe.curigliano@ieo.it
Investigator:
Last name:
Giuseppe Curigliano
Email:
Principal Investigator
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Phone:
+81471331111
Email:
kgoto@east.ncc.go.jp
Investigator:
Last name:
Koichi Goto
Email:
Principal Investigator
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Contact:
Phone:
+81559895222
Email:
ha.murakami@scchr.jp
Investigator:
Last name:
Haruyasu Murakami
Email:
Principal Investigator
Facility:
Name:
Cancer Institute Hospital of JFCR
Address:
City:
Koto-Ku
Zip:
135-8550
Country:
Japan
Status:
Not yet recruiting
Contact:
Phone:
81335200111
Email:
ken.uchibori@jfcr.or.jp
Investigator:
Last name:
Uchibori Ken
Email:
Principal Investigator
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Phone:
+82220723559
Email:
gabriel9@snu.ac.kr
Investigator:
Last name:
Kim Tae Min
Email:
Principal Investigator
Facility:
Name:
Asan Medical Center
Address:
City:
Seul
Zip:
5505
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Phone:
82230103214
Email:
leedaeho@amc.seoul.kr
Investigator:
Last name:
Lee Dae Ho
Email:
Principal Investigator
Facility:
Name:
Antoni van Leeuwenhoek
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Phone:
+31205122958
Email:
g.ruiter@nki.nl
Investigator:
Last name:
Gerrina Ruiter
Email:
Principal Investigator
Facility:
Name:
Leiden University Medical Center (LUMC)
Address:
City:
Leiden
Zip:
2333ZA
Country:
Netherlands
Status:
Recruiting
Contact:
Phone:
+31205129098
Email:
e.f.smit@lumc.nl
Investigator:
Last name:
Egbert Smit
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Not yet recruiting
Contact:
Phone:
34934894350
Email:
efelip@vhio.net
Investigator:
Last name:
Enriqueta Felip Font
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28401
Country:
Spain
Status:
Not yet recruiting
Contact:
Phone:
+34955013068
Email:
lpazaresr@seom.org
Investigator:
Last name:
Luis Paz-Ares Rodriguez
Email:
Principal Investigator
Facility:
Name:
The Christie Hospital
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Phone:
+441612912829
Email:
yvonne.summers@nhs.net
Investigator:
Last name:
Yvonne Summers
Email:
Principal Investigator
Start date:
May 25, 2023
Completion date:
December 2027
Lead sponsor:
Agency:
Taiho Oncology, Inc.
Agency class:
Industry
Source:
Taiho Oncology, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05765734
