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

NCT04982926 | Terminated Phase 1 FDA Drug

• 2 other identifiers: TAS2940-1012021-002189-41
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Dose Escalation:Maximum Tolerated Dose (MTD)

  Determine the incidence of dose-liming toxicities (DLTs) and adverse events (AEs) graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 within the first cycle

  One Month

• Dose Expansion:Overall Response Rate

  Document the ORR, defined as proportion of patients experiencing a best overall response of Complete Response (CR) or Partial response (PR) based on investigator accessed radiographic response per RECIST 1.1 or RANO criteria

  6 Months

Secondary Outcomes (7)

• Dose Escalation: Overall Response Rate (ORR)

  6 Months

• Dose Escalation:Pharmacokinetic (PK) Profile

  3 Months

• Dose Expansion:Incidence of treatment-emergent Adverse Events (Safety and tolerability)

  Estimated up to 6 months

• Dose Expansion:Duration of Response (DOR)

  Estimated up to 6 months

• Dose Expansion:Disease Control Rate (DCR)

  Estimated up to 6 months

Study Arms (5)

TAS2940 Dose Escalation

EXPERIMENTAL

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.

Drug: TAS2940

Dose Expansion Non-small Cell Lung Cancer

EXPERIMENTAL

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

Drug: TAS2940

Dose Expansion Breast Cancer

EXPERIMENTAL

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

Drug: TAS2940

Dose Expansion Gliblastoma

EXPERIMENTAL

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

Drug: TAS2940

Dose Expansion Solid tumors

EXPERIMENTAL

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

Drug: TAS2940

Interventions

TAS2940 DRUG

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

TAS2940 Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead

Study Sites (3)

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

CLCC Gustave Roussy

Villejuif, Cedex, 94805, France

Location

MeSH Terms

Conditions

Glioblastoma; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: July 29, 2021
• Study Start: September 16, 2021
• Primary Completion: February 26, 2025
• Study Completion: March 24, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); US (2)