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

  • STATUS
    Recruiting
  • End date
    Jun 11, 2025
  • participants needed
    42
  • sponsor
    Taiho Oncology, Inc.
Updated on 11 March 2022
cancer
measurable disease
HER2
EGFR
brain tumor
erbb2
her2/neu-positive breast cancer
primary brain tumors
lung carcinoma

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.

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.

Details
Condition Solid Tumor, Glioblastoma, Non-small Cell Lung Cancer, Breast Cancer
Treatment TAS2940
Clinical Study IdentifierNCT04982926
SponsorTaiho Oncology, Inc.
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Have histologically confirmed solid cancer that is locally advanced and metastatic and 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 primary brain 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 Criteria

Non-stable brain metastases
Have significant cardiovascular disorder
Have not recovered from prior cancer treatment
A serious illness or medical condition
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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