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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05584111
Study type Interventional
Source STORM Therapeutics LTD
Contact Melinda Snyder
Phone 617-233-4057
Email melinda.snyder@stormtherapeutics.com
Status Recruiting
Phase Phase 1
Start date November 15, 2022
Completion date May 30, 2025

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