Solid TumorPhase 1NCT04982926
A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer
A Phase 1 study testing TAS2940 in people with Solid Tumor and Glioblastoma, run by Taiho Oncology, Inc. at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Glioblastoma, Non-small Cell Lung Cancer
- What is being tested?
- TAS2940
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 16 Sep 2021to 24 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Non-stable brain metastases
- Have significant cardiovascular disorder
- Have not recovered from prior cancer treatment
- A serious illness or medical condition
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Tennessee Oncology
Nashville, Tennessee, 37203
About this study
Official title: A Phase 1 Study of TAS2940 in Patients With Locally Advanced or Metastatic Solid Tumors With EGFR and / or HER2 Aberrations
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.
Read the 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.
- Conditions
- Solid Tumor, Glioblastoma, Non-small Cell Lung Cancer, Breast Cancer
- Being tested
- TAS2940
- Medical subject headings
- Glioblastoma, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS2940Drug
Study participants with solid tumors and EGFR or HER2 aberrations will receive TAS2940 tablets daily at increasing doses until MTD is reached.
TAS2940Drug
Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TAS2940 |
| 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 Receives: Drug: TAS2940 |
| Dose Expansion Breast Cancer | Experimental | Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations Receives: Drug: TAS2940 |
| Dose Expansion Gliblastoma | Experimental | Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations. Receives: Drug: TAS2940 |
| Dose Expansion Solid tumors | Experimental | Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations. Receives: Drug: TAS2940 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 Months
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start16 Sep 2021
- Primary completion26 Feb 2025
- Study completion24 Mar 2025
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Taiho Oncology, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982926
- Sponsor's protocol ID
- TAS2940-101
- Other IDs
- 2021-002189-41
- Status last verified
- Oct 2025
- First submitted
- 23 Jul 2021
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of TAS2940 in Patients With Locally Advanced or Metastatic Solid Tumors With EGFR and / or HER2 Aberrations
- ClinicalTrials.gov ID
- NCT04982926
- Acronym / sponsor ID
- TAS2940-101
- Conditions
- Solid Tumor, Glioblastoma, Non-small Cell Lung Cancer, Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TAS2940 Dose Escalation | Experimental | Drug: TAS2940Dose 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 Non-small Cell Lung Cancer | Experimental | Drug: TAS2940Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations |
| Dose Expansion Breast Cancer | Experimental | Drug: TAS2940Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations |
| Dose Expansion Gliblastoma | Experimental | Drug: TAS2940Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations. |
| Dose Expansion Solid tumors | Experimental | Drug: TAS2940Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- Have measurable or non- measurable disease per RECIST criteria v1.1 or RANO
- Any solid tumor with EGFR and / or HER2 aberration
Key exclusion criteria (4 listed)
- Non-stable brain metastases
- Have significant cardiovascular disorder
- Have not recovered from prior cancer treatment
- A serious illness or medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS2940Study participants with solid tumors and EGFR or HER2 aberrations will receive TAS2940 tablets daily at increasing doses until MTD is reached. | Drug | TAS2940 Dose Escalation |
| TAS2940Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase. | Drug | Dose Expansion Breast Cancer, Dose Expansion Gliblastoma, Dose Expansion Non-small Cell Lung Cancer, Dose Expansion Solid tumors |
Primary outcome
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
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
7 secondary outcomes
Dose Escalation: Overall Response Rate (ORR)
Time frame: 6 Months
Dose Escalation:Pharmacokinetic (PK) Profile
Time frame: 3 Months
Dose Expansion:Incidence of treatment-emergent Adverse Events (Safety and tolerability)
Time frame: Estimated up to 6 months
Dose Expansion:Duration of Response (DOR)
Time frame: Estimated up to 6 months
Dose Expansion:Disease Control Rate (DCR)
Time frame: Estimated up to 6 months
Dose Expansion:Progression Free Survival (PFS)
Time frame: Estimated up to 6 months
Dose Expansion:Pharmacokinetic profile of TAS2940
Time frame: 3 Months
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAS2940 in people with Solid Tumor and Glioblastoma, run by Taiho Oncology, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation:Maximum Tolerated Dose (MTD) (time frame: One Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.