Trial of ProAgio in Advanced/Metastatic Colorectal Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06867822
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Colorectal Cancer
  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ProAgio — DRUG
    ProAgio is a pegylated protein with a single pegylated site. The 12,131 Dalton protein is produced in E. coli and is composed of 105 amino acids with no disulfide bonds. The structure of the polyethylene glycol moiety is Methoxy PEG maleimide 30000.
  • FOLFIRI — DRUG
    FOLFIRI is a combination of three drugs: (leucovorian, fluorouracil, and irinotecan) used to treat advanced metastatic colorectal cancer. FOLFIRI is commercially available will be administered using standard dosing regimen as per institutional guidelines.
  • Bevacizumab — DRUG
    Bevacizumab is a recombinant humanized monoclonal antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A). Bevacizumab is commercially available and will be administered using standard dosing regimen as per institutional guidelines.

Study Details

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.

Key Dates

Start date
Jul 17, 2025
Status verified
Aug 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: dose escalation ProAgio + FOLFIRI + bevacizumab dose levels tested for RP2D
    Dose level ProAgio mg/Kg FOLFIRI + bevacizumab 1. MTD-2 (6.4\*) FOLFIRI + bevacizumab 2. MTD-1 (10.7) FOLFIRI + bevacizumab 3. MTD (12.5) FOLFIRI + bevacizumab 4. MTD+1 (16\*) FOLFIRI + bevacizumab ProAgio will be administered via IV over 60 minutes on Day 1, 8, 15, and 21 every 4-week cycle. Bevacizumab 5 mg/kg, Irinotecan 180 mg/m2, 5-Flurouracil infusion 2400 mg/m2 will be administered via IV on Day 1, and 15 every 4-week cycle. 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 listed above, maximum of 15 subjects.
  • Experimental: Phase Ib: dose expansion ProAgio + FOLFIRI + bevacizumab
    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 Measure

Change in NCI CTCAE scale version 5.0 [ Time Frame: Baseline, up to 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Margaret Thomas, MPH
[email protected]
Midhun Malla, MD (PRINCIPAL_INVESTIGATOR)
Bassel El-Rayes, MD (SUB_INVESTIGATOR)
Garima Gupta, MD (SUB_INVESTIGATOR)
Darryl Outlaw, MD (SUB_INVESTIGATOR)
Syed Hussaini, MD (SUB_INVESTIGATOR)
Memet Akce, MD (SUB_INVESTIGATOR)

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