DF9001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express epidermal growth factor receptor (EGFR). The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having selected solid tumors (monotherapy and in combination with pembrolizumab).
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Number, severity, and duration of treatment-related adverse events (TRAEs) according to NCI-CTCAE v5.0.
Timeframe: Screening visit up to 28 days after last treatment on the study.
Number of patients with AEs and TRAEs.
Timeframe: Screening visit up to 28 days after last treatment on the study.
Assessment of number of dose limiting toxicities experienced on study as defined per criteria in the study protocol
Timeframe: First 4 weeks of treatment for each subject.
Assess Overall Response Rate
Timeframe: Through 90 days after completion of the study, an average of 1 year.