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NCT03269526 · ClinicalTrials.gov registry record · Phase 1
BATs Treatment for Pancreatic Cancer, Phase Ib/II
A Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Adenocarcinoma, sponsored by University of Virginia.
- Active
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT03269526: Active Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Adenocarcinoma, sponsored by University of Virginia.
NCT03269526 is a Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Adenocarcinoma that is active but no longer recruiting, run by University of Virginia. The registered enrollment target is 22 participants, below the 89-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03269526, a Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Adenocarcinoma, is active but no longer recruiting, sponsored by University of Virginia.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
This protocol will confirm toxicities and estimate the clinical efficacy of combining anti-CD3 x anti-EGFR bispecific antibody (EGFRBi) armed activated T cells (EGFR BATs) given to patients with locally advanced or metastatic pancreatic cancer who have received at least one dose of first line chemotherapy and may have responding, stable or progressive disease. Phase Ib will confirm a safe dose of 8 infusions, given twice weekly, of EGFR-BATs in 3 to 6 subjects. The phase II portion of the trial will test the clinical efficacy of this dose in 22 patients (including those in Phase Ib).
Primary Outcome
Safety will be assessed by incidence and severity of adverse events, changes in laboratory findings, physical examinations, vital signs, and the number of dose limiting toxicities and other discontinuations due to adverse events.
Conditions Studied
Interventions
- DRUG EGFR BATs after standard of care chemo
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2017-07-28 |
| Est. Completion | 2025-06-01 |
| Phase | Phase 1 |
What the registry record for NCT03269526 still lists
NCT03269526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 89-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (75% lower).
The record links to 2 conditions, with Metastatic Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which EGFR BATs after standard of care chemo is the first listed.
NCT03269526 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT03269526 about?
NCT03269526 is a clinical study titled "BATs Treatment for Pancreatic Cancer, Phase Ib/II". This protocol will confirm toxicities and estimate the clinical efficacy of combining anti-CD3 x anti-EGFR bispecific antibody (EGFRBi) armed activated T cells (EGFR BATs) given to patients with locally advanced or metastatic pancreatic cancer who have received at least one dose of first line chemot...
What is the current status of trial NCT03269526?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2017-07-28. Estimated completion is 2025-06-01.
What conditions does trial NCT03269526 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma.
What interventions are being tested in trial NCT03269526?
The interventions under investigation include: EGFR BATs after standard of care chemo (DRUG).
Who is sponsoring clinical trial NCT03269526?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03269526 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03269526's enrollment target sits among peer trials
22 29th of 37 higher than 9 of 37 other Metastatic Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Pancreatic Adenocarcinoma 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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