Stopped: Enrollment into the phase 2 portion was never initiated.
IMC-I109V is an immune-mobilizing monoclonal T cell receptor (TCR) against viruses (ImmTAV®), a new class of bispecific protein therapeutics designed for the treatment of chronic hepatitis B virus (HBV) infection (CHB). This is the first in-human study of IMC-I109V in persons with CHB.
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Parts 1, 2, and 3: Incidence and treatment-emergent adverse events (TEAEs)
Timeframe: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Incidence of serious adverse events (SAEs)
Timeframe: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Incidence of adverse events (AEs) leading to treatment discontinuation
Timeframe: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Incidence of dose-limiting toxicities (DLTs)
Timeframe: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Changes in Vital Signs
Timeframe: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Changes in electrocardiogram
Timeframe: Up to 30 days after the last infusion of study treatment
Parts 1, 2, and 3: Change in safety laboratory parameters
Timeframe: Up to 30 days after the last infusion of study treatment