Oral Administration of STC-15 in Subjects With Advanced Malignancies
Status:
Recruiting
Trial end date:
2024-09-30
Target enrollment:
Participant gender:
Summary
This Phase 1, multi-center, open-label, first-in-human study evaluates multiple ascending
daily oral doses of STC-15 in Q3W treatment cycles in a 3+3 cohort design with dose levels
determined by a modified Fibonacci algorithm. The study is designed to systematically assess
safety and tolerability, pharmacokinetics, pharmacodynamics and clinical activity of STC-15
in adult subjects with advanced malignancies. Dose levels for further evaluation in expansion
cohorts will be selected based on all available PK, pharmacodynamic, target engagement,
efficacy, safety, and tolerability data including long-term safety data beyond dose limiting
toxicities (DLTs). The study may be amended to evaluate STC-15 in combination with a Food and
Drug Administration-approved standard of care treatment regimen, which could encompass
targeted/chemotherapy, radiation therapy and/or immunotherapy with immune checkpoint
blockers.