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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04982926
Recruitment Status : Recruiting
First Posted : July 29, 2021
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumor Glioblastoma Non-small Cell Lung Cancer Breast Cancer Drug: TAS2940 Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of TAS2940 in Patients With Locally Advanced or Metastatic Solid Tumors With EGFR and / or HER2 Aberrations
Actual Study Start Date : September 16, 2021
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TAS2940 Dose Escalation
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
Study participants with solid tumors and EGFR or HER2 aberrations will receive TAS2940 tablets daily at increasing doses until MTD is reached.
Experimental: Dose Expansion Non-small Cell Lung Cancer
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations
 Drug: TAS2940
Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.
Experimental: Dose Expansion Breast Cancer
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations
 Drug: TAS2940
Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.
Experimental: Dose Expansion Gliblastoma
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.
 Drug: TAS2940
Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.
Experimental: Dose Expansion Solid tumors
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.
 Drug: TAS2940
Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.


Outcome Measures
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Primary Outcome Measures :
  1. Dose Escalation:Maximum Tolerated Dose (MTD) [ Time Frame: One Month ]
    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

  2. Dose Expansion:Overall Response Rate [ Time Frame: 6 Months ]
    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


Secondary Outcome Measures :
  1. Dose Escalation: Overall Response Rate (ORR) [ Time Frame: 6 Months ]
    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

  2. Dose Escalation:Pharmacokinetic (PK) Profile [ Time Frame: 3 Months ]
    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. Dose Expansion:Incidence of treatment-emergent Adverse Events (Safety and tolerability) [ Time Frame: Estimated up to 6 months ]
    Safety and tolerability of TAS2940 based on reported AEs, graded according to NCI-CTCAE v.5.0

  4. Dose Expansion:Duration of Response (DOR) [ Time Frame: Estimated up to 6 months ]
    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.

  5. Dose Expansion:Disease Control Rate (DCR) [ Time Frame: Estimated up to 6 months ]
    DCR, defined as the proportion of patients experiencing a best overall response of Stable Disease (SD), PR or CR

  6. Dose Expansion:Progression Free Survival (PFS) [ Time Frame: Estimated up to 6 months ]
    Date of PR or CR to date of objective progression or death due to any cause.

  7. Dose Expansion:Pharmacokinetic profile of TAS2940 [ Time Frame: 3 Months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04982926


Contacts
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Contact: Karim Benhadji, MD 609-250-7336 clinicaltrialinfo@taihooncology.com

Locations
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United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
France
CLCC Gustave Roussy Recruiting
Villejuif, Cedex, France, 94805
Sponsors and Collaborators
Taiho Oncology, Inc.
More Information
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Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04982926    
Other Study ID Numbers: TAS2940-101
2021-002189-41 ( EudraCT Number )
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
 Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue