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A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors
NCT04478279 · View on ClinicalTrials.gov ↗
Study Summary
This is an open-label, two-part, phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 administered IV in patients with advanced solid tumors. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.
Conditions Studied
Interventions
- DRUG Temozolomide
- RADIATION Radiation
- DRUG ST101
Study Locations (11)
Other
- Edinburgh Cancer Centre — Edinburgh
- The Beaston West of Scotland Cancer Centre — Glasgow
- University of Leeds — Leeds
- Sarah Cannon Research Institute UK — London
California
- University of California, San Francisco — San Francisco
Colorado
- Sarah Cannon Research Institute — Denver
Illinois
- Northwestern Medicine Cancer Centers — Warrenville
Michigan
- START Midwest — Grand Rapids
New York
- Columbia University — New York
North Carolina
- Duke University School of Medicine — Durham
Tennessee
- Sarah Cannon Research Institute — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04478279
The ClinicalTrials.gov registry entry for NCT04478279 describes a study currently listed as active not recruiting. 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 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sapience 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 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Temozolomide 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: NCT04478279 reports 11 study locations spanning 8 distinct geographic areas — top geographies include Other, California, Colorado. 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 NCT04478279 about?
NCT04478279 is a clinical study titled "A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors". This is an open-label, two-part, phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 administered IV in patients with advanced solid tumors. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase a...
What is the current status of trial NCT04478279?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 125 participants. The study started on 2020-07-01. Estimated completion is 2026-12.
What conditions does trial NCT04478279 study?
This clinical trial studies the following conditions: Breast Cancer, Prostate Cancer, Glioblastoma, Metastatic Breast Cancer, Metastatic Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04478279?
The interventions under investigation include: Temozolomide (DRUG), Radiation (RADIATION), ST101 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04478279?
This trial is sponsored by Sapience 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 NCT04478279 being conducted?
This trial has 11 study locations across California, Colorado, Illinois, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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