OncoMatch/Clinical Trials/NCT06867822
Trial of ProAgio in Advanced/Metastatic Colorectal Cancer
Is NCT06867822 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including ProAgio and FOLFIRI for advanced colorectal cancer.
Treatment: ProAgio · FOLFIRI · Bevacizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage IV
Patients with advanced or metastatic CRC; Presence of measurable disease by RECIST 1.1 criteria
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: FOLFIRI chemotherapy
Prior exposure to FOLFIRI chemotherapy
Lab requirements
Blood counts
Absolute Neutrophil Count ≥1.5 x 10^9/L; Platelets ≥100 x 10^9/L; Hemoglobin (Hgb) ≥9 g/dL
Kidney function
Creatinine Clearance ≥60 mL/min using Cockcroft-Gault formula
Liver function
Total bilirubin ≤1.5 x ULN; AST ≤2.5 x ULN (≤5.0 x ULN with liver metastasis); ALT ≤2.5 x ULN (≤5.0 x ULN with liver metastasis)
Cardiac function
Normal ECG defined as QTcF at screening <450 ms (male), <460 ms (female); no significant cardiovascular disease (see exclusion criteria)
Patient must meet the following laboratory values at the screening visit: ... see full criteria for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
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