Actively Recruiting
Trial of ProAgio in Advanced/Metastatic Colorectal Cancer
Led by University of Alabama at Birmingham · Updated on 2025-08-24
27
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
T
The V Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial of ProAgio in Advanced/Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older at the time of consent
- Histologic or cytologic diagnosis of colorectal adenocarcinoma
- Have advanced or metastatic colorectal cancer
- ECOG performance status of 0 or 1
- For dose escalation: FOLFIRI plus bevacizumab considered appropriate standard therapy; prior FOLFOX treatment allowed
- For dose expansion: no prior 5FU-based therapy for metastatic disease; prior FOLFOX/CAPOX in neoadjuvant/adjuvant setting allowed if recurrence-free for at least 1 year
- Presence of a metastatic lesion safely biopsyable (for 4 patients in dose expansion phase)
- Meet specific laboratory values at screening (ANC ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9 g/dL, creatinine clearance ≥60 mL/min, bilirubin ≤1.5 x ULN, AST ≤2.5 x ULN or ≤5.0 x ULN if liver metastasis, ALT ≤2.5 x ULN or ≤5.0 x ULN if liver metastasis, proteinuria <2+ on urine dipstick with confirmatory 24-hour urine if ≥2+ and <1 g protein/24 hours)
- Blood pressure ≤160/100 mm Hg
- Measurable disease by RECIST 1.1 within 28 days prior to first dose
- Normal ECG with QTcF <450 ms (males) or <460 ms (females)
- Women must be not of childbearing potential or use highly effective contraception during and after study as specified
- Women of childbearing potential must have negative pregnancy test at screening
- Men sexually active with women of childbearing potential must use barrier contraception and not donate sperm during and after study
- Provide IRB/IEC approved informed consent
- Able to understand and comply with study procedures
- Agree not to participate in another interventional study during treatment
You will not qualify if you...
- Prior exposure to FOLFIRI chemotherapy
- Clinically significant peripheral neuropathy (Grade 3 or higher)
- Untreated central nervous system lesions, unless treated and stable for at least 4 weeks
- History of allogenic bone marrow or solid organ transplant
- History or current interstitial lung disease or non-infectious pneumonitis
- Prior or concurrent malignancy that may interfere with study assessments
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Known hypersensitivity or intolerance to study treatments
- HIV infection except well-controlled cases
- Active hepatitis B or C infection except as specified
- Severe chronic or active infections requiring systemic therapy
- Recent investigational drug use or device within 14 days or 5 half-lives
- Pregnant or breastfeeding women or planning pregnancy
- Major surgery within 28 days or incomplete recovery within 14 days before randomization
- Severe systemic illnesses or psychiatric/social conditions interfering with compliance
- History of gastrointestinal perforation, fistula, life-threatening bleeding, proteinuria >1 g/24 hours, or wound healing issues
- Significant cardiovascular disease including recent heart failure, myocardial infarction, unstable angina, stroke, serious arrhythmias, or recent deep vein thrombosis/pulmonary embolism unless treated
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Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
M
Midun Malla, MD
CONTACT
M
Margaret Thomas, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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