A Phase 1 interventional study of TAS2940 and TAS2940 in Solid Tumor, Glioblastoma and Non-small Cell Lung Cancer, sponsored by Taiho Oncology, Inc.. Terminated at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by Taiho Oncology, Inc. · Phase 1, Interventional, and Treatment
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 29 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Taiho Oncology, Inc. is the lead sponsor of 62 studies on the registry; 8 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Dose Escalation:
Dose Expansion:
Exclusion Criteria:
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
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations
Drug: TAS2940
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations
Drug: TAS2940
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.
Drug: TAS2940
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.
Drug: TAS2940
Study participants with solid tumors and EGFR or HER2 aberrations will receive TAS2940 tablets daily at increasing doses until MTD is reached.
Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.
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
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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 3 Months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Taiho Oncology, Inc.