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NCT05584111 · ClinicalTrials.gov registry record · Phase 1
Oral Administration of STC-15 in Subjects With Advanced Malignancies
A Phase 1 study of Cancer and Advanced Solid Tumor, sponsored by STORM Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 3
- Study locations
NCT05584111: Completed Phase 1 study of Cancer and Advanced Solid Tumor, sponsored by STORM Therapeutics.
NCT05584111 is a Phase 1 study of Cancer and Advanced Solid Tumor that has completed, run by STORM Therapeutics. The registered enrollment target is 42 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05584111, a Phase 1 study of Cancer and Advanced Solid Tumor, has completed, sponsored by STORM Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
To evaluate the incidence, severity, and duration of adverse events
Conditions Studied
Interventions
- DRUG STC-15
Study Locations (3)
Texas
- The University of Texas MD Anderson Cancer Center - Houston
- South Texas Accelerated Research Therapeutics - San Antonio
Arizona
- Honor Health - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2022-11-15 |
| Est. Completion | 2024-12-22 |
| Phase | Phase 1 |
What the finished NCT05584111 record still lists
NCT05584111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which STC-15 is the first listed.
NCT05584111 reports a single indexed study location in Texas, Arizona.
Frequently Asked Questions
What is clinical trial NCT05584111 about?
NCT05584111 is a clinical study titled "Oral Administration of STC-15 in Subjects With Advanced Malignancies". 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, p...
What is the current status of trial NCT05584111?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2022-11-15. Estimated completion is 2024-12-22.
What conditions does trial NCT05584111 study?
This clinical trial studies the following conditions: Cancer, Advanced Solid Tumor, Advanced Cancer.
What interventions are being tested in trial NCT05584111?
The interventions under investigation include: STC-15 (DRUG).
Who is sponsoring clinical trial NCT05584111?
This trial is sponsored by STORM Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05584111 being conducted?
This trial has 3 study locations across Arizona, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05584111's enrollment target sits among peer trials
42 457th of 615 higher than 157 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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