NCT04982926

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

A Phase 1 Study of TAS2940 in Patients With Locally Advanced or Metastatic Solid Tumors With EGFR and / or HER2 Aberrations

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2021-09-16
• Primary completion: 2025-02-26
• Completion: 2025-03-24
• First posted: 2021-07-29
• Last updated: 2025-10-14

Locations

3 sites across 2 countries: United States, France

Regulatory

• FDA-regulated drug study