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

Taiho Pharma

Status and phase: Terminated; Phase 1

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

Treatments: Drug: TAS2940

Study type: Interventional

Funder types: Industry

Identifiers

NCT04982926

TAS2940-101

2021-002189-41 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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29 participants in 5 patient groups

TAS2940 Dose Escalation

Experimental group

Description:

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.

Treatment:

Drug: TAS2940

Drug: TAS2940

Dose Expansion Non-small Cell Lung Cancer

Experimental group

Description:

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

Treatment:

Drug: TAS2940

Drug: TAS2940

Dose Expansion Breast Cancer

Experimental group

Description:

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

Treatment:

Drug: TAS2940

Drug: TAS2940

Dose Expansion Gliblastoma

Experimental group

Description:

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

Treatment:

Drug: TAS2940

Drug: TAS2940

Dose Expansion Solid tumors

Experimental group

Description:

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

Treatment:

Drug: TAS2940

Drug: TAS2940