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NCT06141031 · ClinicalTrials.gov registry record · Phase 1
Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
A Phase 1 study of Pancreatic Cancer, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 2
- Study locations
NCT06141031: Active Phase 1 study of Pancreatic Cancer, sponsored by Washington University School of Medicine.
NCT06141031 is a Phase 1 study of Pancreatic Cancer that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 5 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06141031, a Phase 1 study of Pancreatic Cancer, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 2
- Study locations
Study Summary
The survival rate for patients with pancreatic cancer remains at a dismal 10% or less at 5 years, and although trials integrating stereotactic body radiation therapy (SBRT) alone have shown improvement in local control, initial invigoration of immune response, and relief of symptom burden, SBRT has not demonstrated any improvement in survival. Preclinical research has established that STAT3 inhibition given concurrently with SBRT and in the maintenance phase acts as a synergistic agent that enhances the pro-inflammatory effects of SBRT while reducing its undesired effects (including fibrosis and immunosuppression). This study exploits the window of opportunity post-chemotherapy to advance the hypothesis that the addition of STAT3 inhibition in combination with SBRT will be safe and will enhance 2-year progression-free survival.
Primary Outcome
* The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the dose-limiting toxicity (DLT) evaluation period. * The final determination of the RP2D will be based on an overall evaluation of the totality of the available data observed in phase IB.
Conditions Studied
Interventions
- DRUG TTI-101
- RADIATION Stereotactic body radiation therapy
Study Locations (2)
Colorado
- University of Colorado - Aurora
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2024-01-16 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 1 |
What the registry record for NCT06141031 still lists
NCT06141031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 2 interventions - of which TTI-101 is the first listed.
NCT06141031 reports a single indexed study location in Colorado, Missouri.
Frequently Asked Questions
What is clinical trial NCT06141031 about?
NCT06141031 is a clinical study titled "Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma". The survival rate for patients with pancreatic cancer remains at a dismal 10% or less at 5 years, and although trials integrating stereotactic body radiation therapy (SBRT) alone have shown improvement in local control, initial invigoration of immune response, and relief of symptom burden, SBRT has ...
What is the current status of trial NCT06141031?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2024-01-16. Estimated completion is 2029-06-30.
What conditions does trial NCT06141031 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT06141031?
The interventions under investigation include: TTI-101 (DRUG), Stereotactic body radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT06141031?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06141031 being conducted?
This trial has 2 study locations across Colorado, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06141031's enrollment target sits among peer trials
5 275th of 278 higher than 4 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic 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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