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

NCT ID: NCT04982926

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-16
• Study Completion Date: 2025-03-24

Brief 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.

Detailed 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.

Conditions

Solid Tumor; Glioblastoma; Non-small Cell Lung Cancer; Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAS2940 Dose Escalation

Dose escalation will assess the safety and determine the maximum tolerated dose, the recommended phase 2 dose and the recommended dosing regimen of TAS2940 administered orally.

Group Type: EXPERIMENTAL

TAS2940

Intervention Type: DRUG

Study participants with solid tumors and EGFR or HER2 aberrations will receive TAS2940 tablets daily at increasing doses until MTD is reached.

Dose Expansion Non-small Cell Lung Cancer

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations

Group Type: EXPERIMENTAL

TAS2940

Intervention Type: DRUG

Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.

Dose Expansion Breast Cancer

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations

Group Type: EXPERIMENTAL

TAS2940

Intervention Type: DRUG

Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.

Dose Expansion Gliblastoma

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.

Group Type: EXPERIMENTAL

TAS2940

Intervention Type: DRUG

Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.

Dose Expansion Solid tumors

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.

Group Type: EXPERIMENTAL

TAS2940

Intervention Type: DRUG

Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.

Interventions

TAS2940

Study participants with solid tumors and EGFR or HER2 aberrations will receive TAS2940 tablets daily at increasing doses until MTD is reached.

Intervention Type: DRUG

TAS2940

Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiho Oncology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tennessee Oncology

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

CLCC Gustave Roussy

Villejuif, Cedex, France

Countries

United States; France

Other Identifiers

2021-002189-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TAS2940-101

Identifier Type: -

Identifier Source: org_study_id