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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002189-41 | EudraCT Number |
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After careful review of Taiho's ongoing portfolio and data obtained so far in the context of broader landscape of clinical development in NSCLC HER2mut, Sponsor has made a strategic decision to terminate this study and not based on safety concerns.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAS2940 Dose Escalation | Experimental | 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. |
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| Dose Expansion Non-small Cell Lung Cancer | Experimental | Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations |
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| Dose Expansion Breast Cancer | Experimental | Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations |
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| Dose Expansion Gliblastoma | Experimental | Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations. |
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| Dose Expansion Solid tumors | Experimental | Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAS2940 | Drug | Study participants with solid tumors and EGFR or HER2 aberrations will receive TAS2940 tablets daily at increasing doses until MTD is reached. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Dose Escalation:Pharmacokinetic (PK) Profile |
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Inclusion Criteria:
Dose Escalation:
Dose Expansion:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States | ||
| University of Texas MD Anderson Cancer Center |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| TAS2940 | Drug | Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Houston |
| Texas |
| 77030 |
| United States |
| CLCC Gustave Roussy | Villejuif | Cedex | 94805 | France |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |