Back to resultsA Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer
Primary Purpose
Solid Tumor, Glioblastoma, Non-small Cell Lung Cancer
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TAS2940
TAS2940
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumor
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
Sites / Locations
- Tennessee OncologyRecruiting
- University of Texas MD Anderson Cancer CenterRecruiting
- CLCC Gustave RoussyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
TAS2940 Dose Escalation
Dose Expansion Non-small Cell Lung Cancer
Dose Expansion Breast Cancer
Dose Expansion Gliblastoma
Dose Expansion Solid tumors
Arm 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.
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
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
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.
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
Dose Expansion:Progression Free Survival (PFS)
Date of PR or CR to date of objective progression or death due to any cause.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04982926
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Glioblastoma, Non-small Cell Lung Cancer, Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAS2940 Dose Escalation
Arm Type
Experimental
Arm 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.
Arm Title
Dose Expansion Non-small Cell Lung Cancer
Arm Type
Experimental
Arm Description
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations
Arm Title
Dose Expansion Breast Cancer
Arm Type
Experimental
Arm Description
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations
Arm Title
Dose Expansion Gliblastoma
Arm Type
Experimental
Arm Description
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.
Arm Title
Dose Expansion Solid tumors
Arm Type
Experimental
Arm Description
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.
Intervention Type
Drug
Intervention Name(s)
TAS2940
Intervention Description
Study participants with solid tumors and EGFR or HER2 aberrations will receive TAS2940 tablets daily at increasing doses until MTD is reached.
Intervention Type
Drug
Intervention Name(s)
TAS2940
Intervention Description
Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.
Primary Outcome Measure Information:
Title
Dose Escalation:Maximum Tolerated Dose (MTD)
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
Time Frame
One Month
Title
Dose Expansion:Overall Response Rate
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
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Dose Escalation: Overall Response Rate (ORR)
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
Time Frame
6 Months
Title
Dose Escalation:Pharmacokinetic (PK) Profile
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
Time Frame
3 Months
Title
Dose Expansion:Incidence of treatment-emergent Adverse Events (Safety and tolerability)
Description
Safety and tolerability of TAS2940 based on reported AEs, graded according to NCI-CTCAE v.5.0
Time Frame
Estimated up to 6 months
Title
Dose Expansion:Duration of Response (DOR)
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.
Time Frame
Estimated up to 6 months
Title
Dose Expansion:Disease Control Rate (DCR)
Description
DCR, defined as the proportion of patients experiencing a best overall response of Stable Disease (SD), PR or CR
Time Frame
Estimated up to 6 months
Title
Dose Expansion:Progression Free Survival (PFS)
Description
Date of PR or CR to date of objective progression or death due to any cause.
Time Frame
Estimated up to 6 months
Title
Dose Expansion:Pharmacokinetic profile of TAS2940
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
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taiho Oncology, INC
Phone
609-250-7336
Email
clinicaltrialinfo@taihooncology.com
Facility Information:
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
CLCC Gustave Roussy
City
Villejuif
State/Province
Cedex
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer
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