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A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®18087 in Subjects with Advanced Neuroendocrine and Gastrointestinal Stromal Tumors (DUET-1)
The primary purposes of this research study are to: determine the safety and tolerability of the investigational drug, XmAb18087; if the XmAb18087 works in treating these types of tumors; if participants have side effects from XmAb18087 and to find the best dose for treating their type of tumor. XmAb18087 is an investigational drug that is designed to activate the participant's own cells to kill their tumor.
Primary Objectives: 1. To determine the safety and tolerability profile of XmAb18087 in subjects with advanced well-differentiated neuroendocrine tumors (NET) of pancreatic, gastrointestinal, lung, and undetermined origin, and subjects with advanced gastrointestinal stromal tumors (GIST). 2. To identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087 administered by intravenous (IV) dosing on days 1, 8, 15, and 22 of each 28-day cycle in subjects with advanced NET or advanced GIST. Secondary Objectives: 1. To characterize the pharmacokinetics (PK) and immunogenicity of XmAb18087. 2. To preliminarily assess anti-tumor activity of XmAb18087 by overall response rates (ORR) and progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria, as well as duration of response. Exploratory Objectives: 1. To assess the incidence, timing, and severity of cytokine release syndrome (CRS) by following: a. CRS-related adverse events (AEs; incidence and grade of AEs and incidence of serious AEs ; [SAEs]); b. Biomarkers of CRS. 2. To assess the effect of XmAb18087 administration on subject fasting blood glucose values. 3. To measure changes in peripheral blood lymphocyte subsets and in T-cell activation/exhaustion after XmAb18087 administration by flow cytometry. 4. To characterize pharmacodynamics (PD) in NET subjects by correlation of response with serum Chromogranin A levels, Octreoscan® values, and NETestTM results after XmAb18087administration. 5. To evaluate by immunohistochemistry, when possible, tumor cell expression of somatostatin receptor (SSTR) 2 and programmed cell death ligand-1 (PD-L1), and tumor infiltrating immune cell expression of programmed cell death protein-1 (PD-1)/PD-L1 after XmAb18087 administration.