nctId: NCT06364410 id: NCI-2024-02982 id: NCI-2024-02982 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 10554 type: OTHER domain: University of Texas MD Anderson Cancer Center LAO id: 10554 type: OTHER domain: CTEP 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 overallStatus: NOT_YET_RECRUITING date: 2024-08-30 date: 2026-03-31 date: 2026-03-31 date: 2024-04-15 date: 2024-04-25 name: National Cancer Institute (NCI) class: NIH 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. 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 studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Azenosertib name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Echocardiography name: Magnetic Resonance Imaging name: Multigated Acquisition Scan name: Trastuzumab Deruxtecan measure: Maximum tolerated dose measure: Recommended phase 2 dose measure: Incidence of dose limiting toxicities (DLTs) measure: Incidence of adverse events (AEs) measure: Objective response rate (ORR) measure: Progression free survival (PFS) measure: Duration of response measure: Pharmacodynamic effects in the tumor measure: Predictors of response and acquired resistance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False