Phase 1 Study of XS-04 Tablets to Assess Safety, Dosage, and Early Effectiveness in Adults with Relapsed or Refractory B-cell Lymphoma, AML, or MDS

What this Trial Is About

Researchers are studying XS-04 tablets in patients with relapsed or refractory blood cancers, including B-cell lymphoma, acute myeloid leukemia, and myelodysplastic syndrome. The main goal is to evaluate the safety and tolerability of XS-04, determine the highest dose patients can handle, and find the recommended dose for future studies. The trial also looks at how the body processes the drug and explores early signs of how well the treatment works, including how food affects drug levels and the relationship between drug exposure and biological markers. This is a Phase I, open-label study with a dose escalation phase and a dose expansion phase. In the dose escalation phase, patients receive increasing doses of XS-04 tablets orally twice daily in 28-day cycles, starting with a smaller initial dose to observe drug behavior. Dose levels range from 1 mg up to 160 mg per day, with adjustments allowed based on safety and drug levels. Following this, selected doses will be studied further in the dose expansion phase with specific patient groups. Treatment is continuous throughout each cycle. Participants will attend visits for safety monitoring, laboratory tests, and assessments throughout the study. Researchers will track adverse events, measure drug levels in blood after single and multiple doses, and evaluate treatment impact through biomarker analysis. Bone marrow samples and imaging will be used to assess disease status. Participants will be followed for up to 24 months to monitor side effects and determine the maximum tolerated dose and recommended Phase II dose. The study ensures careful monitoring of health and treatment effects during and after the trial.

A Study of XS-04 in Patients with Relapsed or Refractory Hematologic Malignancies