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NCT04478279 · ClinicalTrials.gov registry record · Phase 1
A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors
A Phase 1 study of Breast Cancer and Prostate Cancer, sponsored by Sapience Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 125
- Enrollment target
- 11
- Study locations
NCT04478279: Active Phase 1 study of Breast Cancer and Prostate Cancer, sponsored by Sapience Therapeutics.
NCT04478279 is a Phase 1 study of Breast Cancer and Prostate Cancer that is active but no longer recruiting, run by Sapience Therapeutics. The registered enrollment target is 125 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04478279, a Phase 1 study of Breast Cancer and Prostate Cancer, is active but no longer recruiting, sponsored by Sapience Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 125 participants
- Enrollment target
- 11
- Study locations
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.
Primary Outcome
Number of Participants with a Dose-Limiting Toxicity (DLT)
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 |
What the registry record for NCT04478279 still lists
NCT04478279 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).
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.
NCT04478279 lists 11 locations in 8 states (Other, California, Colorado).
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.
What interventions are being tested in trial NCT04478279?
The interventions under investigation include: Temozolomide (DRUG), Radiation (RADIATION), ST101 (DRUG).
Who is sponsoring clinical trial NCT04478279?
This trial is sponsored by Sapience Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04478279's enrollment target sits among peer trials
125 499th of 1224 higher than 722 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast 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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