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Oral Administration of STC-15 in Subjects With Advanced Malignancies
NCT05584111 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05584111
The ClinicalTrials.gov registry entry for NCT05584111 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is STORM Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05584111 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Texas, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05584111?
The interventions under investigation include: STC-15 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05584111?
This trial is sponsored by STORM Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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