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A Phase 1b Study Evaluating the Safety, Tolerability and Immunogenicity of CMB305 (Sequentially Administered LV305 and G305) in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1
Researchers want to find out if an investigational agent called CMB305 can help stimulate the body's immune system against NY-ESO-1 and the participant's tumor. The main purpose of this study is to see if the investigational agent is safe.
Primary: To evaluate the safety and tolerability of CMB305 (sequentially administered LV305 and G305) in patients with locally advanced, relapsed, or metastatic cancer expressing NY-ESO-1. Secondary/Exploratory: To evaluate clinical responses (by Immune-related Response Criteria (irRC) modified to use RECIST (v 1.1) measurement criteria), time to progression (TTP) and progression-free survival (PFS) as a preliminary assessment of clinical activity. To evaluate the cellular and humoral immunogenicity of CMB305 in patients with locally advanced, relapsed, or metastatic cancer expressing NY-ESO-1. To evaluate pre- and post-regimen blood samples for potential biomarkers of immunogenicity and clinical tumor response. To evaluate available pre- and post-regimen tumor tissue for histologic, immunohistologic, and genomic markers.