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

Phase 1TerminatedNCT04982926

Taiho Oncology, Inc.29 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor Glioblastoma Non-small Cell Lung Cancer Breast Cancer

Interventions

TAS2940DRUG

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

TAS2940DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Tennessee Oncology

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

CLCC Gustave Roussy

Villejuif, Cedex, France

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 6 Months

Secondary Outcomes

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

Time frame: 6 Months

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

Time frame: 3 Months

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

Time frame: Estimated up to 6 months

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.

Data from ClinicalTrials.gov

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