Actively Recruiting
Phase I/Ib Trial of ProAgio with 5-fluorouracil, Irinotecan, and Bevacizumab for Advanced/Metastatic Colorectal Cancer
Led by University of Alabama at Birmingham · Updated on 2025-08-24
27
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety, pharmacokinetics, and clinical activity of ProAgio combined with 5-fluorouracil, irinotecan (FOLFIRI), and bevacizumab in patients with untreated advanced or metastatic colorectal cancer (CRC). This open-label Phase I/Ib trial uses an Accelerated titration BOIN design to determine the recommended Phase 2 dose (RP2D) of ProAgio when combined with the standard FOLFIRI + bevacizumab treatment. The study includes patients with good performance status and adequate organ function, excluding those with recent surgeries, thromboembolic events, or significant cardiovascular disease. The trial consists of a dose-escalation phase testing four dose levels of ProAgio combined with FOLFIRI and bevacizumab, administered intravenously on specific days within 4-week cycles. ProAgio is given on Days 1, 8, 15, and 21, while bevacizumab, irinotecan, and 5-fluorouracil are administered on Days 1 and 15. After identifying the maximum tolerated dose (MTD) and RP2D, an expansion cohort of 12 subjects will confirm the safety and assess preliminary activity of this combination therapy. Participants will undergo regular assessments including monitoring of adverse events using the NCI CTCAE scale, pharmacokinetic sampling, and tumor response evaluations up to 18 months. Researchers will measure progression-free survival and overall survival during this period. Safety and clinical activity will be closely tracked throughout the treatment cycles, with participant involvement lasting several months depending on treatment response and study protocols.
CONDITIONS
Brief Title
Trial of ProAgio in Advanced/Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Histologic or cytologic diagnosis of colorectal adenocarcinoma
- Advanced or metastatic colorectal cancer
- ECOG performance status of 0 or 1
- For dose escalation: suitable for FOLFIRI plus bevacizumab; prior FOLFOX treatment allowed
- For dose expansion: no previous 5FU-based therapy for metastatic disease; prior FOLFOX/CAPOX allowed if recurrence free for 1 year
- Measurable disease by RECIST 1.1 criteria within 28 days before treatment
- Adequate organ function with specific lab value requirements
- Blood pressure ≤160/100 mm Hg
- Normal ECG with QTcF <450 ms (male) or <460 ms (female)
- Women must be either not of childbearing potential or use highly effective birth control
- Negative pregnancy test for women of childbearing potential
- Men must use effective birth control if sexually active with women of childbearing potential
- Ability to understand and comply with study procedures
- Signed informed consent
- Agreement not to join another interventional study during this trial
You will not qualify if you...
- Prior treatment with FOLFIRI chemotherapy
- Peripheral neuropathy grade 3 or higher
- Untreated central nervous system lesions or recent progression
- History of bone marrow or solid organ transplant
- Known interstitial lung disease or pneumonitis
- Concurrent or interfering malignancies
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Hypersensitivity to study treatment components
- HIV infection except well-controlled cases
- Active hepatitis B or C infection with specific conditions
- Severe infections requiring systemic therapy
- Recent investigational drug or device use
- Pregnancy or breastfeeding or plans to become pregnant/father a child during or shortly after study
- Major surgery within 28 days before randomization or incomplete recovery within 14 days
- Severe comorbid illnesses or psychiatric/social situations interfering with compliance
- History of gastrointestinal perforation, fistula, severe bleeding, proteinuria >1 g/24 hours, wound healing issues
- Significant cardiovascular disease including recent heart failure, myocardial infarction, unstable angina, serious arrhythmias, or recent thromboembolism unless fully treated
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 4-week cycles until disease progression or discontinuation
Participants receive ProAgio combined with FOLFIRI and Bevacizumab. ProAgio is administered intravenously on Days 1, 8, 15, and 21 of each 4-week cycle. FOLFIRI and Bevacizumab are administered intravenously on Days 1 and 15 of each 4-week cycle.
Weekly visits for up to 4 weeks per cycle
Duration - Up to 18 months after treatment start
Participants are monitored for safety and treatment outcomes including progression and survival after treatment ends.
Visits scheduled periodically during follow-up
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
M
Margaret Thomas, MPH
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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