The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors.
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During dose escalation and dose expansion measure incidence and severity of treatment emergent adverse events by CTCAE v5.0
Timeframe: Through study completion, an average of 10 months
During dose escalation characterize dose-limiting toxicities (DLTs)
Timeframe: 1 treatment cycle (28 days)
During dose expansion describe the Overall Response Rate using RECIST v1.1
Timeframe: Every 63 days until study completion, approximately 10 months on average
During dose expansion describe the Disease Control Rate using RECIST v1.1 (Part 2a only)
Timeframe: 4 months
During dose expansion describe the PSA30 response rate for participants with prostate cancer
Timeframe: Baseline, weekly during the first 2 cycles (56 days), bi-weekly during the Cycle 3 (28 days), and then monthly (up to approximately 7 months)