NCT05584111

Oral Administration of STC-15 in Subjects With Advanced Malignancies

Phase 1 Study to Evaluate the Safety, PK, PD, and Clinical Activity of STC-15, a METTL-3 Inhibitor, in Subjects With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: STORM Therapeutics LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Cancer
• Advanced Solid Tumor
• Cancer

Interventions

Type	Name	Description
DRUG	STC-15	STC-15 oral capsules various dosing regimen in 3-week cycles

Timeline

• Start date: 2022-11-15
• Primary completion: 2024-08-30
• Completion: 2024-12-22
• First posted: 2022-10-18
• Last updated: 2025-03-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study