A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer

Last updated: October 9, 2025
Sponsor: Taiho Oncology, Inc.
Overall Status: Terminated

Phase

1

Condition

Gliomas

Neuroblastoma

Breast Cancer

Treatment

TAS2940

Clinical Study ID

NCT04982926
TAS2940-101
2021-002189-41
  • Ages > 18
  • All Genders

Study Summary

This is a first-in-human, open label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and the preliminary antitumor activity of TAS2940 in patients with advanced or metastatic solid tumors who are not candidates for approved or available therapies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have histologically confirmed solid cancer that is locally advanced and metastaticand available standard treatment options have been exhausted

  • Have adequate organ function

  • ECOG PS 0-1

Dose Escalation:

  • Have measurable or non- measurable disease per RECIST criteria v1.1 or RANO

  • Any solid tumor with EGFR and / or HER2 aberration

Dose Expansion:

  • Have measurable disease per RECIST criteria v1.1 for solid tumor (excluding primarybrain tumor) or RANO (for glioblastoma)

  • Cohort A: Non-small cell lung cancer (NSCLC)

  • Cohort B: HER2 positive breast cancer

  • Cohort C: Recurrent or refractory glioblastoma

  • Cohort D: Other solid tumors with EGFR or HER2 aberrations

Exclusion

Exclusion Criteria:

  • Non-stable brain metastases

  • Have significant cardiovascular disorder

  • Have not recovered from prior cancer treatment

  • A serious illness or medical condition

Study Design

Total Participants: 29
Treatment Group(s): 1
Primary Treatment: TAS2940
Phase: 1
Study Start date:
September 16, 2021
Estimated Completion Date:
March 24, 2025

Study Description

TAS2940 is a small molecule inhibitor of ERBB family proteins HER2 and EGFR. It has not been evaluated in human subjects yet. The study will be conducted in 2 parts, dose escalation and dose expansion. The dose escalation part will assess the safety and determine the maximum tolerated dose, the recommended phase 2 dose and the recommended dosing regimen of TAS2940 administered orally. The dose expansion part will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.

Connect with a study center

  • CLCC Gustave Roussy

    Villejuif, Cedex 94805
    France

    Site Not Available

  • CLCC Gustave Roussy

    Villejuif 2968705, Cedex 94805
    France

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.