This is a multi-center first-in-human, Phase 1, open-label, dose ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of single ascending doses of SBT777101 administered intravenously (IV) in subjects with active rheumatoid arthritis (RA) and an inadequate response to at least 2 prior biologic or targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD) therapies with different mechanisms of action.
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This study will collect real-world clinical and patient reported outcomes (PRO) and diary data from eligible patients with documented Human Epidermal Growth Factor Receptor 2 (HER2+) [globally] or HER2-low [North America only] in routine clinical practice.
This trial will help to determine if either the experimental arm (adjuvant reirradiation plus pembrolizumab, followed by pembrolizumab to complete 12 months total of pembrolizumab and/or pembrolizumab alone for 12 months) significantly improves Overall Survival (OS) compared to adjuvant reirradiation plus concurrent platinum chemotherapy in high risk patients.
This is a phase I trial to see whether patients are able to adhere to a modified, high fat/low carbohydrate diet (the sHFLC + KetoPhyt Diet) with a supplement named KetoPhyt that includes ketones and anti-inflammatory properties.
The classic ketogenic diet (KD) is difficult for patients to adhere to due to its stringent nature. A modified KD has been developed that mimics the glucose lowering, ketone raising effects and the anti-cancer outcomes of the KD.