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A Study of TAS3351 in NSCLC Patients With EGFRmt (TAS3351)

Primary Purpose

Non-Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TAS3351 oral administration
Sponsored by
Taiho Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer, NSCLC, EGFR mutation, C797S mutation, TAS3351

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tennessee OncologyRecruiting
  • University of Texas M. D. Anderson Cancer Center
  • Institut Gustave Roussy
  • Universitaetsklinikum Koeln
  • National Cancer Center Hospital EastRecruiting
  • Shizuoka Cancer Center
  • Seoul National University Hospital
  • Inje University Haeundae Paik Hospital
  • Antoni van Leeuwenhoek
  • Leiden University Medical Center (LUMC)
  • Hospital Universitario 12 de Octubre
  • The Christie Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

TAS3351 Part A (Dose Escalation)

TAS3351 Part B (Dose Expansion)

TAS3351 Part C (Phase 2)

Arm Description

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.

Outcomes

Primary Outcome Measures

Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351
Adverse Events
Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351
Incidence of dose limiting toxicities (DLTs)
Dose Expansion: To explore the efficacy of TAS3351
Objective Response Rate (ORR)
Phase 2: To assess the efficacy of TAS3351
Objective Response Rate (ORR)

Secondary Outcome Measures

Dose Escalation:To evaluate the antitumor activity of TAS3351
Objective response rate (ORR)
Dose Escalation:To evaluate the antitumor activity of TAS3351
Duration of response (DoR)
Dose Escalation:To evaluate the antitumor activity of TAS3351
Disease control rate (DCR)
Dose Escalation: To evaluate the antitumor activity of TAS3351
Progression free survival (PFS)
Dose Escalation: To evaluate the antitumor activity of TAS3351
Overall Survival (OS)
Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351
Evaluate the maximum plasma concentration (Cmax)
Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351
Area under the plasma concentration-time curve (AUC)
Dose Expansion: To confirm the safety and tolerability of TAS3351 at the recommended phase 2 dose and dosing schedule
Adverse Events (AEs)
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Duration of response (DoR) by ICR
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Progression Free Survival (PFS) by ICR
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Disease Control Rate (DCR) by ICR
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Objective Response Rate (ORR) by Investigator Assessment
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Duration of Response (DoR) by Investigator Assessment
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Progression Free Survival (PFS) by Investigator Assessment
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Disease Control Rate (DCR) by Investigator Assessment
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Intracranial Objective Response Rate (icORR)
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Intracranial Duration of Response (icDOR)
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Overall survival (OS)
Phase 2: To evaluate the safety and tolerability of TAS3351
Adverse Events (AEs)
Phase 2: To further assess the efficacy of TAS3351
Duration of response (DoR) by ICR
Phase 2: To further assess the efficacy of TAS3351
Progression Free Survival (PFS) by ICR
Phase 2: To further assess the efficacy of TAS3351
Disease Control Rate (DCR) by ICR
Phase 2: To further assess the efficacy of TAS3351
Objective Response Rate (ORR) by Investigator Assessment
Phase 2: To further assess the efficacy of TAS3351
Duration of Response (DoR) by Investigator Assessment
Phase 2: To further assess the efficacy of TAS3351
Progression Free Survival (PFS) by Investigator Assessment
Phase 2: To further assess the efficacy of TAS3351
Disease Control Rate (DCR) by Investigator Assessment
Phase 2: To further assess the efficacy of TAS3351
Intracranial Objective Response Rate (icORR)
Phase 2: To further assess the efficacy of TAS3351
Intracranial Duration of Response (icDOR)
Phase 2: To further assess the efficacy of TAS3351
Overall survival (OS)
Phase 2:To evaluate patient reported outcomes (PROs)
responses to patient questionnaires

Full Information

First Posted
February 8, 2023
Last Updated
October 10, 2023
Sponsor
Taiho Oncology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05765734
Brief Title
A Study of TAS3351 in NSCLC Patients With EGFRmt
Acronym
TAS3351
Official Title
A Phase 1/2 Study of TAS3351 in Patients With Advanced Non-Small Cell Lung Cancer and EGFR Mutations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Non-Small Cell Lung Cancer, NSCLC, EGFR mutation, C797S mutation, TAS3351

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAS3351 Part A (Dose Escalation)
Arm Type
Experimental
Arm Description
Dose escalation will assess the safety and determine the recommended phase 2 dose and regimen of TAS3351 administered orally.
Arm Title
TAS3351 Part B (Dose Expansion)
Arm Type
Experimental
Arm Description
TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose determined in Part A.
Arm Title
TAS3351 Part C (Phase 2)
Arm Type
Experimental
Arm Description
To assess efficacy of TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose.
Intervention Type
Drug
Intervention Name(s)
TAS3351 oral administration
Intervention Description
TAS3351 will be administered orally
Primary Outcome Measure Information:
Title
Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351
Description
Adverse Events
Time Frame
baseline through cycle 1(each cycle is 21 days)
Title
Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351
Description
Incidence of dose limiting toxicities (DLTs)
Time Frame
baseline through cycle 1(each cycle is 21 days)
Title
Dose Expansion: To explore the efficacy of TAS3351
Description
Objective Response Rate (ORR)
Time Frame
estimated 9 months
Title
Phase 2: To assess the efficacy of TAS3351
Description
Objective Response Rate (ORR)
Time Frame
estimated 3 years
Secondary Outcome Measure Information:
Title
Dose Escalation:To evaluate the antitumor activity of TAS3351
Description
Objective response rate (ORR)
Time Frame
estimated 20 months
Title
Dose Escalation:To evaluate the antitumor activity of TAS3351
Description
Duration of response (DoR)
Time Frame
estimated 20 months
Title
Dose Escalation:To evaluate the antitumor activity of TAS3351
Description
Disease control rate (DCR)
Time Frame
estimated 20 months
Title
Dose Escalation: To evaluate the antitumor activity of TAS3351
Description
Progression free survival (PFS)
Time Frame
estimated 20 months
Title
Dose Escalation: To evaluate the antitumor activity of TAS3351
Description
Overall Survival (OS)
Time Frame
estimated 20 months
Title
Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351
Description
Evaluate the maximum plasma concentration (Cmax)
Time Frame
Cycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)
Title
Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351
Description
Area under the plasma concentration-time curve (AUC)
Time Frame
ECycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)
Title
Dose Expansion: To confirm the safety and tolerability of TAS3351 at the recommended phase 2 dose and dosing schedule
Description
Adverse Events (AEs)
Time Frame
estimated 9 months
Title
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Description
Duration of response (DoR) by ICR
Time Frame
estimated 9 months
Title
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Description
Progression Free Survival (PFS) by ICR
Time Frame
estimated 9 months
Title
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Description
Disease Control Rate (DCR) by ICR
Time Frame
estimated 9 months
Title
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Description
Objective Response Rate (ORR) by Investigator Assessment
Time Frame
estimated 9 months
Title
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Description
Duration of Response (DoR) by Investigator Assessment
Time Frame
estimated 9 months
Title
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Description
Progression Free Survival (PFS) by Investigator Assessment
Time Frame
estimated 9 months
Title
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Description
Disease Control Rate (DCR) by Investigator Assessment
Time Frame
estimated 9 months
Title
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Description
Intracranial Objective Response Rate (icORR)
Time Frame
estimated 9 months
Title
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Description
Intracranial Duration of Response (icDOR)
Time Frame
estimated 9 months
Title
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Description
Overall survival (OS)
Time Frame
estimated 9 months
Title
Phase 2: To evaluate the safety and tolerability of TAS3351
Description
Adverse Events (AEs)
Time Frame
estimated 3 years
Title
Phase 2: To further assess the efficacy of TAS3351
Description
Duration of response (DoR) by ICR
Time Frame
estimated 3 years
Title
Phase 2: To further assess the efficacy of TAS3351
Description
Progression Free Survival (PFS) by ICR
Time Frame
estimated 3 years
Title
Phase 2: To further assess the efficacy of TAS3351
Description
Disease Control Rate (DCR) by ICR
Time Frame
estimated 3 years
Title
Phase 2: To further assess the efficacy of TAS3351
Description
Objective Response Rate (ORR) by Investigator Assessment
Time Frame
estimated 3 years
Title
Phase 2: To further assess the efficacy of TAS3351
Description
Duration of Response (DoR) by Investigator Assessment
Time Frame
estimated 3 years
Title
Phase 2: To further assess the efficacy of TAS3351
Description
Progression Free Survival (PFS) by Investigator Assessment
Time Frame
estimated 3 years
Title
Phase 2: To further assess the efficacy of TAS3351
Description
Disease Control Rate (DCR) by Investigator Assessment
Time Frame
estimated 3 years
Title
Phase 2: To further assess the efficacy of TAS3351
Description
Intracranial Objective Response Rate (icORR)
Time Frame
estimated 3 years
Title
Phase 2: To further assess the efficacy of TAS3351
Description
Intracranial Duration of Response (icDOR)
Time Frame
estimated 3 years
Title
Phase 2: To further assess the efficacy of TAS3351
Description
Overall survival (OS)
Time Frame
estimated 3 years
Title
Phase 2:To evaluate patient reported outcomes (PROs)
Description
responses to patient questionnaires
Time Frame
estimated 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taiho Oncology, Inc
Phone
609-250-7336
Email
clinicaltrialinfo@taihooncology.com
Facility Information:
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
615-329-7274
Email
mjohnson@tnonc.com
First Name & Middle Initial & Last Name & Degree
Melissa Johnson
Facility Name
University of Texas M. D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuning Le
Facility Name
Institut Gustave Roussy
City
Villejuif cedex
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+33549444444
Email
david.planchard@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
David Planchard
Facility Name
Universitaetsklinikum Koeln
City
Koeln
State/Province
Nordrhein Westfalen
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+4922147889050
Email
juergen.wolf@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Juergen Wolf
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba-Ken
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81471331111
Email
kgoto@east.ncc.go.jp
First Name & Middle Initial & Last Name & Degree
Koichi Goto
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
State/Province
Shizuoka-Ken
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+81559895222
Email
ha.murakami@scchr.jp
First Name & Middle Initial & Last Name & Degree
Haruyasu Murakami
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Democratic People's Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+82220723559
Email
gabriel9@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Kim Tae Min
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
82 10-9346-2846
Email
onelement@daum.net
First Name & Middle Initial & Last Name & Degree
Il Hwan Kim
Facility Name
Antoni van Leeuwenhoek
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+31205122958
Email
g.ruiter@nki.nl
First Name & Middle Initial & Last Name & Degree
Gerrina Ruiter
Facility Name
Leiden University Medical Center (LUMC)
City
Leiden
ZIP/Postal Code
2333ZA
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+31205129098
Email
e.f.smit@lumc.nl
First Name & Middle Initial & Last Name & Degree
Egbert Smit
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28401
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+34955013068
Email
lpazaresr@seom.org
First Name & Middle Initial & Last Name & Degree
Luis Paz-Ares Rodriguez
Facility Name
The Christie Hospital
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+441612912829
Email
yvonne.summers@nhs.net
First Name & Middle Initial & Last Name & Degree
Summers Yvonne

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of TAS3351 in NSCLC Patients With EGFRmt

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