Clinical Trials /

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

NCT04982926

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04982926

Trial Eligibility

Document

Title

  • Brief Title: A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer
  • 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 IDs

  • ORG STUDY ID: TAS2940-101
  • SECONDARY ID: 2021-002189-41
  • NCT ID: NCT04982926

Conditions

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

Interventions

DrugSynonymsArms
TAS2940Dose Expansion Breast Cancer

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
TAS2940 Dose EscalationExperimental
  • TAS2940
Dose Expansion Non-small Cell Lung CancerExperimental
  • TAS2940
Dose Expansion Breast CancerExperimental
  • TAS2940
Dose Expansion GliblastomaExperimental
  • TAS2940
Dose Expansion Solid tumorsExperimental
  • TAS2940

Eligibility Criteria

        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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Escalation:Maximum Tolerated Dose (MTD)
Time Frame:One Month
Safety Issue:
Description: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

Secondary Outcome Measures

Measure:Dose Escalation: Overall Response Rate (ORR)
Time Frame:6 Months
Safety Issue:
Description: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
Measure:Dose Escalation:Pharmacokinetic (PK) Profile
Time Frame:3 Months
Safety Issue:
Description:: 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
Measure:Dose Expansion:Incidence of treatment-emergent Adverse Events (Safety and tolerability)
Time Frame:Estimated up to 6 months
Safety Issue:
Description:Safety and tolerability of TAS2940 based on reported AEs, graded according to NCI-CTCAE v.5.0
Measure:Dose Expansion:Duration of Response (DOR)
Time Frame:Estimated up to 6 months
Safety Issue:
Description: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.
Measure:Dose Expansion:Disease Control Rate (DCR)
Time Frame:Estimated up to 6 months
Safety Issue:
Description:DCR, defined as the proportion of patients experiencing a best overall response of Stable Disease (SD), PR or CR
Measure:Dose Expansion:Progression Free Survival (PFS)
Time Frame:Estimated up to 6 months
Safety Issue:
Description:Date of PR or CR to date of objective progression or death due to any cause.
Measure:Dose Expansion:Pharmacokinetic profile of TAS2940
Time Frame:3 Months
Safety Issue:
Description: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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Taiho Oncology, Inc.

Last Updated

July 29, 2021