The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in the study.
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Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Timeframe: Baseline, through study completion, an average of 10 months.
Number of patients with Dose Limiting Toxicities (DLTs)
Timeframe: Baseline, through study completion, an average of 10 months.
To determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) for EVOLVE104
Timeframe: Baseline, through study completion, an average of 10 months.
To determine the recommended phase 2 dose (RP2D) of EVOLVE104
Timeframe: Safety evaluations will be done as described above. PK and PD to be done each cycle (28 days) at pre-dose and post dose starting Day 1 at various time points, dependent upon treatment regimen assigned, through study completion, an average of 10 months.