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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982926
• Other study ID #: TAS2940-101
• Secondary ID: 2021-002189-41
• Status: Recruiting
• Phase: Phase 1
• Start date: September 16, 2021
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Taiho Oncology, Inc.
• Contact: Taiho Oncology, INC
• Phone: 609-250-7336
• Email: clinicaltrialinfo[@]taihooncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• TAS2940
Study participants with solid tumors and EGFR or HER2 aberrations will receive TAS2940 tablets daily at increasing doses until MTD is reached.
• TAS2940
Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.

Locations

Country	Name	City	State
France	CLCC Gustave Roussy	Villejuif	Cedex
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Tennessee Oncology	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Oncology, Inc.

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Dose Escalation: Overall Response Rate (ORR)	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	Dose Escalation:Pharmacokinetic (PK) Profile	Evaluation of the maximum observed plasma concentration; time to reach maximum concentration, area under the Concentration-time curve and time it takes for plasma concentration to fall by half its original value (T1/2) of TAS2940	3 Months
Secondary	Dose Expansion:Incidence of treatment-emergent Adverse Events (Safety and tolerability)	Safety and tolerability of TAS2940 based on reported AEs, graded according to NCI-CTCAE v.5.0	Estimated up to 6 months
Secondary	Dose Expansion:Duration of Response (DOR)	DOR, defined as time from the first documentation of response to date of objective tumor progression or death due to any cause, whichever occurs first.	Estimated up to 6 months
Secondary	Dose Expansion:Disease Control Rate (DCR)	DCR, defined as the proportion of patients experiencing a best overall response of Stable Disease (SD), PR or CR	Estimated up to 6 months
Secondary	Dose Expansion:Progression Free Survival (PFS)	Date of PR or CR to date of objective progression or death due to any cause.	Estimated up to 6 months
Secondary	Dose Expansion:Pharmacokinetic profile of TAS2940	Evaluation of the maximum observed plasma concentration; time to reach maximum concentration, area under the Concentration-time curve and time it takes for plasma concentration to fall by half its original value (T1/2) of TAS2940	3 Months