A Phase I/Ib, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 Monotherapy and in Combination Therapy in Patients with Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors; is designed to assess the safety, tolerability, and preliminary efficacy of DF6215 alone or in combination with pembrolizumab in patients with advanced solid tumors. The study is open-label, meaning both participants and investigators are aware of the treatment being administered.
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Maximum Tolerated Dose (MTD) of DF6215 Monotherapy and in Combination with Pembrolizumab
Timeframe: First 28 days for monotherapy; first 42 days for combination therapy.
Safety and Tolerability of DF6215 Monotherapy and in Combination with Pembrolizumab
Timeframe: Continuously throughout the study, up to 2 years.
Efficacy Expansion: Clinical Activity of DF6215 monotherapy and in combination of Pembrolizumab
Timeframe: Assessed from the start of treatment until disease progression or study end, up to 2 years.