Trial of ProAgio in Advanced/Metastatic Colorectal Cancer
Eligible age
19+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Alabama at Birmingham
You may qualify if…
- ✓ 1. Be ≥18 years of age at the time of consent.
- ✓ 2. Histologic or cytologic diagnosis of colorectal adenocarcinoma (CRC)
- ✓ 3. Patients with advanced or metastatic CRC
- ✓ 4. Performance status, ECOG: 0, 1
- ✓ 5. For dose escalation phase: patients with CRC where FOLFIRI+ bevacizumab is considered appropriate standard therapy (previously treated with FOLFOX based regimen in advanced/metastatic CRC is allowed). For dose expansion phase: patients must not have received 5FU-based therapy previously for metastatic disease. Patients who received FOLFOX/CAPOX regimens in the neoadjuvant/adjuvant setting are allowed if recurrence free survival is at least 1 year or longer since completion of adjuvant therapy.
- ✓ 6. Presence of a metastatic lesion that can be safely biopsied for correlative assays (Only for FOUR patients enrolling on the dose expansion phase).
- ✓ 7. Patient must meet the following laboratory values at the screening visit:
- ✓ Absolute Neutrophil Count ≥1.5 x 109/L
You may not qualify if…
- ✕ 1. Prior exposure to FOLFIRI chemotherapy
- ✕ 2. Clinically significant peripheral neuropathy (\>=Grade 3 per CTCAE 5.0)
- ✕ 3. Any untreated central nervous system (CNS) lesion. However, subjects are eligible if: a) all known CNS lesions have been treated with radiotherapy or surgery and b) patient remained without evidence of CNS disease progression ≥4 weeks after treatment.
- ✕ 4. Allogenic bone marrow or solid organ transplant
- ✕ 5. Known history or current interstitial lung disease or non-infectious pneumonitis
- ✕ 6. Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion.
- ✕ 7. Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen.
- ✕ 8. Subject has known dihydropyrimidine dehydrogenase (DPD) deficiency. (NOTE: DPD testing is not mandatory as part of the trial and can be performed at the discretion of treating provider per local requirements)
Where it's recruiting
Birmingham
Source: ClinicalTrials.gov · NCT06867822 · last updated 2025-08-24