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Gastric AdenocarcinomaPhase 1/2T-DXd_HER2LowNCT07529613

Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and Gastroesophageal Junction Adenocarcinoma

A Phase 1/2 study testing T-DXd, Nivolumab and Capecitabine in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by National Cancer Center Hospital East at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety and tolerability of the combination therapy of T-DXd, nivolumab, and chemotherapy in patients with untreated HER2-low gastric or gastroesophageal junction adenocarcinoma, and to determine the recommended dose. Subsequently, the efficacy and safety at the recommended dose will be assessed. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
T-DXd, Nivolumab and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteJapan
Study dates
20 Dec 2023to 31 Dec 2025
Phase
Phase 1/2
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Historical confirmation of adenocarcinoma of the gastric, gastroesophageal junction, or esophagus is considered by the investigator or subinvestigator to be unresectable advanced or recurrent.
  • HER2 low expression: IHC1+, or IHC2+ and ISH negative [FISH or DISH method] in HER2 test of the primary lesion or metastatic lesion.
  • Having one or more measurable disease as specified in RECIST Guideline version 1.1.
  • Systemic treatment is untreated (local radiation and surgical treatment is acceptable).
  • Age at the date of informed consent is 20 years or older.
  • ECOG Performance status (PS) of 0 or 1.
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  • Has LVEF >= 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before enrollment.
  • Has a corrected QT interval (QTc) =< 470 ms in females, or QTc =< 450 ms in males based on a 12-lead ECG screening within 28 days before enrollment (allowed on the same day of the week). [Fridericia's correction is recommended]
  • The most recent laboratory value within 14 days before enrollment meets all of the following. (Examinations on the same day of the week 2 weeks prior to the date of enrollment are allowed.) (1)Absolute Neutrophil count =< 1,500/mm3 (2)Hemoglobin =< 9.0 g/dL (3)Platelet count =< 100,000/mm3 (4)Total bilirubin =< 1.5 mg/dL (5)AST(GOT) =< 100 IU/L =< 200 IU/L in the presence of hepatic involvement (6)ALT(GPT) =< 100 IU/L =< 200 IU/L in the presence of hepatic involvement (7)Creatinine =< 1.5 mg/dL (8)PT(INR) < 1.8 and aPTT < 60 seconds
  • Has adequate treatment washout period before enrollment (allowed on the same day of the week), defined as:
  • Surgery with general anesthesia: >= 4 weeks ii. Radiotherapy: >= 4 weeks (including palliative stereotactic body radiation therapy to the chest; palliative stereotactic body radiation therapy to other than the chest >= 2 weeks; abdominal vertebral bodies should be included in the abdomen).
  • Chloroquine and hydroxychloroquine: >= 15 days
  • No blood transfusion was performed within 7 days before registration. (Transfusions on the same day of the week prior to the day of enrollment are allowed.)
  • Female of childbearing potential have a negative pregnancy test within 7 days before enrollment (allowed on the same day of the week). Male and Female of childbearing potential agree to contraception for a period (4 months for male and 7 months for Female) from informed consent to the last dose of study drug.
  • Written informed consent of participation in the study has been obtained from the patient.

Who cannot join

  • Has a prior chemotherapy for unresectable advanced or recurrent gastric/esophagogastric junction/esophageal adenocarcinoma. (Note: Patients are eligible if they have received prior preoperative or postoperative adjuvant therapy. However, treatment must have been completed at least 6 months prior to enrollment and progression must have occurred at least 6 months after completion of treatment).
  • Metastases to the central nervous system have been identified. (Only if CNS involvement is clinically suspected, cerebral CT scanning or MRI confirmation is mandatory at the time of screening.).
  • Has a medical history of myocardial infarction or congestive heart failure (New York Heart Association Classes II-IV) within 6 months before enrollment, corresponding to the **troponin levels diagnosed as myocardial infarction as defined by the *manufacturer within 28 days before enrollment (allowed on the same day), unstable angina, or any serious arrhythmia requiring treatment.
  • : Manufacturer refers to a testing company used by a study implementation institution.
  • : Enrollment is allowed if a subject exceeds ULN, if the subject is examined and myocardial infarction can be excluded.
  • Active cancer that requires aggressive treatment, such as chemotherapy or operation
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  • Has serious (hospitalized) complications (intestinal palsy, intestinal obstruction, pulmonary fibrosis, diabetes mellitus that is difficult to control, heart failure, myocardial infarction, unstable angina, renal failure, liver failure, psychiatric disorders, cerebrovascular disorders, etc.)
  • Grade 1 or residual adverse effects of prior therapy that have not resolved to baseline (excluding hair loss).
  • Note:Participants with Grade2 chronic toxicity (Defined as no worse than Grade 2 for at least 3 months prior to enrollment and manageable with standard therapy) who are considered by the investigator to have treatment-related toxicity are eligible for enrollment.
  • Chemotherapy-Induced Neuropathy
  • Malaise
  • Has history of gastrointestinal perforation and/or gastrointestinal fistula within 6 months before enrollment.
  • Has any of the following infections:
  • HBs antigen positive
  • HBs antibody or HBc antibody and HBV-DNA positive
  • Active hepatitis C (e.g., if HCV RNA is detected qualitatively) Patients who are HBsAg positive but who have achieved HBV DNA level < 1.3 log IU/mL (2.1 log copies/mL) after treatment with antiviral drugs such as NAs, are eligible for the study.
  • HIV infection has been documented.
  • Lung diseases are defined as:
  • Has a history of non-infectious interstitial lung disease or pneumonitis that required treatment, has interstitial lung disease or pneumonitis, or these lung diseases cannot be ruled out by radiographic examination before enrollment.
  • Severe pulmonary impairment (e.g., pulmonary embolism within 3 months prior to enrollment, serious bronchial asthma, severe COPD, restrictive pulmonary disease, or pleural effusion).
  • Lung-related autoimmune or connective tissue or inflammatory diseases (e.g., rheumatoid arthritis, Sjogren's syndrome, or sarcoidosis) with clinically severe pulmonary risks.
  • Has history of pneumonectomy.
  • Has history of concomitant autoimmune disease or chronic or recurrent autoimmune disease.
  • Administration of systemic adrenocortical hormones (except prophylactic administration for tests or allergic reactions, and temporary use for the purpose of reducing edema associated with radiotherapy) or immunosuppressants is required, or has received these treatments within 14 days before enrollment in the study.
  • Has unhealed wounds, ulcers, or fractures.
  • If you have uncontrolled acute systemic infection that requires Infusion intravenous antibiotic, antiviral, or antifungal drug.
  • If you have received a live attenuated vaccine (mRNA vaccine or replication-defective adenovirus vaccine is not regarded as live attenuated vaccine) within 30 days before the initial administration.
  • If patients are a pregnancy or breastfeeding patient.
  • Patients who do not take appropriate contraceptive measures during the study and contraceptive period
  • Severe hypersensitivity to the active ingredient or additive of the study drug has been confirmed.
  • Has history/complications of severe hypersensitivity reactions to other monoclonal antibodies.
  • Unwilling or unable to comply with any of implementation matters stipulated in the study implementation protocol or any of the instructions of the physician.
  • The investigator or sub investigator considered it ineligible for the study.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

Other trials in Japan

About this study

Official title: An Open Label Phase 1b/2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for Patients With HER2-Low Gastric and Gastroesophageal Junction Adenocarcinoma

To evaluate the safety and tolerability of the combination therapy of T-DXd, nivolumab, and chemotherapy in patients with untreated HER2-low gastric or gastroesophageal junction adenocarcinoma, and to determine the recommended dose. Subsequently, the efficacy and safety at the recommended dose will be assessed.

Being tested
T-DXd, Nivolumab, Capecitabine, Oxaliplatin
Keywords
Trastuzumab Deruxtecan, T-DXd, DS-8201a, Gastric Cancer, HER2-Low
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T-DXdDrug

    T-DXd (4.4mg/kg, intravenous, q3w)

  • NivolumabDrug

    Nivolumab (360 mg, intravenous, q3w)

  • CapecitabineDrug

    Capecitabine (750mg/m2 twice daily, days 1-14, orally)

  • OxaliplatinDrug

    Oxaliplatin (70mg/m2, intravenous, q3w)

Study groups in NCT07529613
Study groupRoleWhat they receive
T-DXd plus Nivolumab, CapecitabineExperimentalNot described
Receives: Drug: T-DXd; Drug: Nivolumab; Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of DLTs in Phase Ib part

    The incidence of DLTs in each cohort will be calculated for the DLT evaluable population.

    Measured: 3 weeks

  2. ORR in Phase II part

    The ORR is defined as the proportion of participants whose best overall response, as assessed by the principal investigator or sub-investigator according to the RECIST guidelines version 1.1, is either CR or PR.

    Measured: 1 year

Secondary outcomes (5)

  1. Duration of Response (DoR)

    The duration is defined as the period from the date on which a complete response (CR) or partial response (PR) was first confirmed based on the overall response according to the RECIST Guidelines version 1.1, up to the earlier of the date on which disease progression (PD based on imaging) was determined or the date of death from any cause.

    Measured: 1 year

  2. Disease Control Rate (DCR)

    The DCR is defined as the proportion of participants whose best overall response according to the RECIST guidelines version 1.1 was CR or PR, or whose SD persisted for 6 weeks or longer.

    Measured: 1 year

  3. Progression-Free Survival (PFS)

    The period is calculated from the date of registration until the earlier of the date of confirmed progression or the date of death from any cause.

    Measured: 1 year

  4. Overall Survival (OS)

    The period is calculated from the date of registration until the date of death from any cause.

    Measured: 1 year

  5. Incidence of adverse events

    The treatment-emergent AEs will be summarized by CTCAE v5.0

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start20 Dec 2023
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07529613
Sponsor's protocol ID
EPOC2203
Acronym
T-DXd_HER2Low
Status last verified
Apr 2026
First submitted
6 Apr 2026
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing T-DXd, Nivolumab and Capecitabine in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by National Cancer Center Hospital East at 1 site in Japan.

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 15 inclusion and 33 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: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of DLTs in Phase Ib part (time frame: 3 weeks). 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?

On the ClinicalTrials.gov record for NCT07529613.

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 Apr 2026.

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