protocolSection identificationModule nctId: NCT06364410, orgStudyIdInfo id: NCI-2024-02982, secondaryIdInfos id: NCI-2024-02982, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 10554, type: OTHER, domain: University of Texas MD Anderson Cancer Center LAO, secondaryIdInfos id: 10554, type: OTHER, domain: CTEP, secondaryIdInfos id: UM1CA186688, type: NIH, link: https://reporter.nih.gov/quickSearch/UM1CA186688, briefTitle: Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-30, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive and cyclin E amplified gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Azenosertib is in a class of medications called kinase inhibitors. It inhibits a protein called Wee1. Inhibition of the Wee1 protein can make tumor cells more vulnerable to chemotherapy drugs, leading to tumor cell death. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving azenosertib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or more effective in treating patients with locally advanced, metastatic, or unresectable HER2-positive gastric, gastroesophageal junction, or other solid tumors, compared to just trastuzumab deruxtecan alone., conditionsModule conditions: Clinical Stage III Gastric Cancer AJCC v8, conditions: Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, conditions: Clinical Stage IV Gastric Cancer AJCC v8, conditions: Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, conditions: Locally Advanced Gastric Carcinoma, conditions: Locally Advanced Gastroesophageal Junction Adenocarcinoma, conditions: Locally Advanced Malignant Solid Neoplasm, conditions: Metastatic Gastric Carcinoma, conditions: Metastatic Gastroesophageal Junction Adenocarcinoma, conditions: Metastatic Malignant Solid Neoplasm, conditions: Unresectable Gastric Carcinoma, conditions: Unresectable Gastroesophageal Junction Adenocarcinoma, conditions: Unresectable Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Azenosertib, interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Echocardiography, interventions name: Magnetic Resonance Imaging, interventions name: Multigated Acquisition Scan, interventions name: Trastuzumab Deruxtecan, outcomesModule primaryOutcomes measure: Maximum tolerated dose, primaryOutcomes measure: Recommended phase 2 dose, primaryOutcomes measure: Incidence of dose limiting toxicities (DLTs), primaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Pharmacodynamic effects in the tumor, secondaryOutcomes measure: Predictors of response and acquired resistance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False