The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D. Part 4 (RP2D expansion; MoonRISe-2) will assess the overall complete response (CR) in participants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; means the cancer cells are only in the bladder's inner lining).
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Parts 1 to 3: Number of Participants with Adverse Events (AEs)
Timeframe: Up to approximately 7 years 4 months
Parts 1 to 3: Number of Participants with AEs by Severity
Timeframe: Up to approximately 7 years 4 months
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
Timeframe: Up to 28 days
Part 4: Overall Complete Response (CR) in Participants with Intermediate Risk-Non-Muscle Invasive Bladder Cancer (IR-NMIBC)
Timeframe: Up to approximately 7 years 4 months