Trial of ProAgio in Advanced/Metastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
Qualifiers
Be ≥18 years of age at the time of consent.
Histologic or cytologic diagnosis of colorectal adenocarcinoma (CRC)
Patients with advanced or metastatic CRC
Performance status, ECOG: 0, 1
Disqualifiers
Prior exposure to FOLFIRI chemotherapy
Clinically significant peripheral neuropathy (>=Grade 3 per CTCAE 5.0)
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.
Allogenic bone marrow or solid organ transplant
Trial design
Treatments tested in this trial
- ProAgio
- FOLFIRI
- Bevacizumab
Treatment groups
27 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Alabama at Birmingham
Lead sponsor
The V Foundation
Collaborator
Source ClinicalTrials.gov