Phase 1Suspended
Trial of ProAgio in Advanced/Metastatic Colorectal Cancer
A Phase I/Ib Trial of ProAgio, an Anti-avb3 Integrin Cytotoxin, in Combination With 5-fluorouracil , Irinotecan and Bevacizumab for Advanced/Metastatic Colorectal Cancer (ProAgio in CRC)
- Sponsor
- University of Alabama at Birmingham (Academic or other)
- Enrolment
- 27 planned
- Conditions
- Advanced Colorectal Cancer; Metastatic Colorectal Cancer
- Interventions
- ProAgio; FOLFIRI; Bevacizumab
- Ages
- adults, older adults
- Registry
- NCT06867822
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Change in NCI CTCAE scale version 5.0
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered