This Phase I clinical trial will evaluate the safety, tolerability, and immunogenicity of 4 mg doses of ITI-3000 in participants with polyomavirus-positive Merkel cell carcinoma (MCC).
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Number of participants with Dose Limiting Toxicities (DLTs).
Timeframe: Through study completion, up to 12 months.
Number of occurrences of Adverse events/Serious Adverse Events that will be assessed for severity according to the NCI CTCAE, version 5.0.
Timeframe: Through study completion, up to 12 months.
Number of participants with changes from baseline in physical exam findings.
Timeframe: Through study completion, up to 12 months.
Number of participants with changes from baseline in hematology lab results.
Timeframe: Through study completion, up to 12 months.
Number of participants with changes from baseline in chemistry lab results.
Timeframe: Through study completion, up to 12 months.
Number of participants with changes from baseline in urinalysis lab results.
Timeframe: Through study completion, up to 12 months.
Number of participants with changes from baseline vital signs.
Timeframe: Through study completion, up to 12 months.