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

November 20, 2023 updated by: Taiho Oncology, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Val De Marne
      • Villejuif cedex, Val De Marne, France, 94805
        • Not yet recruiting
        • Institut Gustave Roussy
        • Contact:
        • Principal Investigator:
          • David Planchard
  • Germany
    • Nordrhein Westfalen
      • Koeln, Nordrhein Westfalen, Germany, 50937
        • Not yet recruiting
        • Universitaetsklinikum Koeln
        • Contact:
        • Principal Investigator:
          • Juergen Wolf
  • Italy
      • Milano, Italy, 20141
        • Not yet recruiting
        • Ieo Istituto Europeo Di Oncologia
        • Principal Investigator:
          • Giuseppe Curigliano
        • Contact:
  • Japan
      • Koto-Ku, Japan, 135-8550
        • Not yet recruiting
        • Cancer Institute Hospital of JFCR
        • Contact:
        • Principal Investigator:
          • Uchibori Ken
    • Chiba-Ken
      • Kashiwa-shi, Chiba-Ken, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Principal Investigator:
          • Koichi Goto
        • Contact:
    • Shizuoka-Ken
      • Sunto-gun, Shizuoka-Ken, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center
        • Contact:
        • Principal Investigator:
          • Haruyasu Murakami
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Not yet recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Kim Tae Min
      • Seul, Korea, Republic of, 5505
        • Not yet recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Lee Dae Ho
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Not yet recruiting
        • Antoni van Leeuwenhoek
        • Contact:
        • Principal Investigator:
          • Gerrina Ruiter
      • Leiden, Netherlands, 2333ZA
        • Not yet recruiting
        • Leiden University Medical Center (LUMC)
        • Contact:
        • Principal Investigator:
          • Egbert Smit
  • Spain
      • Barcelona, Spain, 8035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Enriqueta Felip Font
        • Contact:
      • Madrid, Spain, 28401
        • Not yet recruiting
        • Hospital Universitario 12 de octubre
        • Principal Investigator:
          • Luis Paz-Ares Rodriguez
        • Contact:
  • United Kingdom
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Not yet recruiting
        • The Christie Hospital
        • Principal Investigator:
          • Yvonne Summers
        • Contact:
  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Not yet recruiting
        • Georgetown University - Lombardi Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Kim Chul
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology
        • Principal Investigator:
          • Melissa Johnson
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • University of Texas M. D. Anderson Cancer Center
        • Principal Investigator:
          • Xiuning Le
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Oncology - Virginia
        • Principal Investigator:
          • Alexander Spira
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: TAS3351 oral administration
TAS3351 will be 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.
Drug: TAS3351 oral administration
TAS3351 will be administered orally
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.
Drug: TAS3351 oral administration
TAS3351 will be administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351
Time Frame: baseline through cycle 1(each cycle is 21 days)
Adverse Events
baseline through cycle 1(each cycle is 21 days)
Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351
Time Frame: baseline through cycle 1(each cycle is 21 days)
Incidence of dose limiting toxicities (DLTs)
baseline through cycle 1(each cycle is 21 days)
Dose Expansion: To explore the efficacy of TAS3351
Time Frame: estimated 9 months
Objective Response Rate (ORR)
estimated 9 months
Phase 2: To assess the efficacy of TAS3351
Time Frame: estimated 3 years
Objective Response Rate (ORR)
estimated 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Escalation:To evaluate the antitumor activity of TAS3351
Time Frame: estimated 20 months
Objective response rate (ORR)
estimated 20 months
Dose Escalation:To evaluate the antitumor activity of TAS3351
Time Frame: estimated 20 months
Duration of response (DoR)
estimated 20 months
Dose Escalation:To evaluate the antitumor activity of TAS3351
Time Frame: estimated 20 months
Disease control rate (DCR)
estimated 20 months
Dose Escalation: To evaluate the antitumor activity of TAS3351
Time Frame: estimated 20 months
Progression free survival (PFS)
estimated 20 months
Dose Escalation: To evaluate the antitumor activity of TAS3351
Time Frame: estimated 20 months
Overall Survival (OS)
estimated 20 months
Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351
Time Frame: Cycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)
Evaluate the maximum plasma concentration (Cmax)
Cycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)
Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351
Time Frame: ECycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)
Area under the plasma concentration-time curve (AUC)
ECycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)
Dose Expansion: To confirm the safety and tolerability of TAS3351 at the recommended phase 2 dose and dosing schedule
Time Frame: estimated 9 months
Adverse Events (AEs)
estimated 9 months
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Time Frame: estimated 9 months
Duration of response (DoR) by ICR
estimated 9 months
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Time Frame: estimated 9 months
Progression Free Survival (PFS) by ICR
estimated 9 months
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Time Frame: estimated 9 months
Disease Control Rate (DCR) by ICR
estimated 9 months
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Time Frame: estimated 9 months
Objective Response Rate (ORR) by Investigator Assessment
estimated 9 months
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Time Frame: estimated 9 months
Duration of Response (DoR) by Investigator Assessment
estimated 9 months
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Time Frame: estimated 9 months
Progression Free Survival (PFS) by Investigator Assessment
estimated 9 months
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Time Frame: estimated 9 months
Disease Control Rate (DCR) by Investigator Assessment
estimated 9 months
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Time Frame: estimated 9 months
Intracranial Objective Response Rate (icORR)
estimated 9 months
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Time Frame: estimated 9 months
Intracranial Duration of Response (icDOR)
estimated 9 months
Dose Expansion: To further explore the anti-tumor efficacy of TAS3351
Time Frame: estimated 9 months
Overall survival (OS)
estimated 9 months
Phase 2: To evaluate the safety and tolerability of TAS3351
Time Frame: estimated 3 years
Adverse Events (AEs)
estimated 3 years
Phase 2: To further assess the efficacy of TAS3351
Time Frame: estimated 3 years
Duration of response (DoR) by ICR
estimated 3 years
Phase 2: To further assess the efficacy of TAS3351
Time Frame: estimated 3 years
Progression Free Survival (PFS) by ICR
estimated 3 years
Phase 2: To further assess the efficacy of TAS3351
Time Frame: estimated 3 years
Disease Control Rate (DCR) by ICR
estimated 3 years
Phase 2: To further assess the efficacy of TAS3351
Time Frame: estimated 3 years
Objective Response Rate (ORR) by Investigator Assessment
estimated 3 years
Phase 2: To further assess the efficacy of TAS3351
Time Frame: estimated 3 years
Duration of Response (DoR) by Investigator Assessment
estimated 3 years
Phase 2: To further assess the efficacy of TAS3351
Time Frame: estimated 3 years
Progression Free Survival (PFS) by Investigator Assessment
estimated 3 years
Phase 2: To further assess the efficacy of TAS3351
Time Frame: estimated 3 years
Disease Control Rate (DCR) by Investigator Assessment
estimated 3 years
Phase 2: To further assess the efficacy of TAS3351
Time Frame: estimated 3 years
Intracranial Objective Response Rate (icORR)
estimated 3 years
Phase 2: To further assess the efficacy of TAS3351
Time Frame: estimated 3 years
Intracranial Duration of Response (icDOR)
estimated 3 years
Phase 2: To further assess the efficacy of TAS3351
Time Frame: estimated 3 years
Overall survival (OS)
estimated 3 years
Phase 2:To evaluate patient reported outcomes (PROs)
Time Frame: estimated 3 years
responses to patient questionnaires
estimated 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Oncology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10073010
  • 2022-502595-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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