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Trial of ProAgio for Advanced/Metastatic Colorectal Cancer

This study is testing a new drug called ProAgio in combination with standard treatments, FOLFIRI (a chemotherapy combination of leucovorin, fluorouracil, and irinotecan) and Bevacizumab (a drug that blocks blood vessel growth), for people with advanced or metastatic colorectal cancer. The main goal is to understand the safety and how ProAgio works in the body, as well as to find the best dose when given with FOLFIRI and Bevacizumab. You may be able to join if you are at least 18 years old, have advanced or metastatic colorectal cancer, and have a good performance status (meaning you are generally active). The study will enroll about 27 participants.

Study design
This is an open-label Phase I/Ib study, meaning both you and your doctors will know which treatments you are receiving. It is designed to test different doses of ProAgio in combination with FOLFIRI and Bevacizumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for changes in side effects (NCI CTCAE scale version 5.0) from when you start the study up to 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06867822

Trial of ProAgio in Advanced/Metastatic Colorectal Cancer

Recruiting
PHASE1Ages 19+InterventionalTreatment
University of Alabama at Birmingham
~27 participants
Updated 2025-08-24 on ClinicalTrials.gov
What's tested:ProAgioFOLFIRIBevacizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in NCI CTCAE scale version 5.0
Measured over Baseline, up to 18 months

Conditions

Advanced Colorectal Cancer
Metastatic Colorectal Cancer

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
Alabama1

Who to contact

Midun Malla, MD
[email protected]
(205) 934-2992
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Absolute Neutrophil Count ≥1.5 x 109/L
Platelets ≥100 x 109/L
Hemoglobin (Hgb) ≥9 g/dL
Creatinine Clearance ≥60 mL/min using Cockcroft-Gault formula
Total bilirubin ≤1.5 x ULN
Aspartate transaminase (AST) ≤2.5 x ULN, except for subjects with liver metastasis, who may only be included if AST ≤5.0 x ULN
Alanine transaminase (ALT) ≤2.5 x ULN, except for subjects with liver metastasis, who may only be included if ALT ≤5.0 x ULN
Urine dipstick reading for proteinuria \< 2+. Participants having ≥ 2+ proteinuria on urine dipstick testing at baseline will undergo a 24-hour urine collection for quantitative assessment of proteinuria and must demonstrate \< 1 g of protein in 24 hours. Participants with urine protein ≥ 1 g per 24 hours will be ineligible 8. Blood pressure \<=160/100 mm Hg 9. Presence of measurable disease by RECIST 1.1 criteria within 28 days prior to the first dose of study treatment. 10. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0- 1 (Appendix A-Performance Status Criteria). 11. Normal ECG defined as the following: QTcF at screening \<450 ms (male subjects), \<460 ms (female subjects) 12. Before enrollment, a woman must be either:

What this trial measures

  • Change in NCI CTCAE scale version 5.0Baseline, up to 18 months

    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.