Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and… (NCT07529613) | Clinical Trial Compass
CompletedPhase 1/2
Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and Gastroesophageal Junction Adenocarcinoma
Japan30 participantsStarted 2023-12-20
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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). \[Fridericia's correction is recommended\]
Exclusion criteria
✕. 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.
✕. Active cancer that requires aggressive treatment, such as chemotherapy or operation
✕. 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).
✕. Has history of gastrointestinal perforation and/or gastrointestinal fistula within 6 months before enrollment.