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NCT06867822 · ClinicalTrials.gov registry record · Phase 1
Trial of ProAgio in Advanced/Metastatic Colorectal Cancer
A Phase 1 study of Metastatic Colorectal Cancer and Advanced Colorectal Cancer, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT06867822: Recruiting Phase 1 study of Metastatic Colorectal Cancer and Advanced Colorectal Cancer, sponsored by University of Alabama at Birmingham.
NCT06867822 is a Phase 1 study of Metastatic Colorectal Cancer and Advanced Colorectal Cancer that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 27 participants, below the 185-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06867822, a Phase 1 study of Metastatic Colorectal Cancer and Advanced Colorectal Cancer, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with 5-fluorouracil, irinotecan (FOLFIRI) and bevacizumab for untreated advanced/metastatic CRC. The study will use an Accelerated titration BOIN design in Phase I to determine the recommended RP2D of ProAgio with FOLFIRI + bevacizumab. The trial will estimate the RP2D of ProAgio when combined with FOLFIRI + bevacizumab, starting from 2 dose levels lower than the estimated RP2D of ProAgio alone. Accelerated titration BOIN design will enroll patients with the 4 combination dose levels. Subjects will be selected based on following criteria: previously untreated advanced/metastatic CRC, ECOG performance status (0-1), and adequate organ functions. Subjects with recent surgeries, history of recent thromboembolic events or significant cardiovascular disease will be excluded. Once the MTD and RP2D of ProAgio with FOLFIRI have been identified, an expansion cohort of 12 subjects with advanced/metastatic CRC will begin. The purpose of the expansion cohort is to confirm the safety of the regimen and provide preliminary data on the activity of ProAgio + FOLFIRI + bevacizumab.
Primary Outcome
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE.
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG ProAgio
- DRUG FOLFIRI
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2025-07-17 |
| Est. Completion | 2028-07 |
| Phase | Phase 1 |
What NCT06867822 shows while recruiting
NCT06867822 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 185-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Bevacizumab is the first listed.
NCT06867822 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT06867822 about?
NCT06867822 is a clinical study titled "Trial of ProAgio in Advanced/Metastatic Colorectal Cancer". This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with 5-fluorouracil, irinotecan (FOLFIRI) and bevacizumab for untreated advanced/metastatic CRC. The study will use an Accelerated titration BOIN ...
What is the current status of trial NCT06867822?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2025-07-17. Estimated completion is 2028-07.
What conditions does trial NCT06867822 study?
This clinical trial studies the following conditions: Metastatic Colorectal Cancer, Advanced Colorectal Cancer.
What interventions are being tested in trial NCT06867822?
The interventions under investigation include: Bevacizumab (DRUG), ProAgio (DRUG), FOLFIRI (DRUG).
Who is sponsoring clinical trial NCT06867822?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06867822 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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