Table of Contents
- Trial overview
- Study design and phase
- Treatment groups and study setting
- Who participated
- What the trial measured
- Trial status and size
Trial overview
This clinical trial studied Magrolimab in people with previously treated advanced inoperable metastatic colorectal cancer (mCRC).[1] The study asked whether adding Magrolimab to standard treatment could improve outcomes and whether the treatment plan was safe and tolerable.[1]
Study design and phase
This was a Phase 2 study, which means it was designed to look at both safety and early signs of benefit in a group of patients with the same disease.[1] It was also randomized and open-label, meaning participants were assigned to treatment groups by chance and both the study team and participants knew which treatment was given.[1]
The study included a safety run-in cohort first, which is a small early group used to check safety and help find the recommended Phase 2 dose (RP2D), or the dose chosen for the main part of the study.[1]
Treatment groups and study setting
The trial compared Magrolimab plus bevacizumab and FOLFIRI against bevacizumab and FOLFIRI without Magrolimab in previously treated participants with metastatic colorectal cancer.[1] FOLFIRI is a combination treatment made up of 5-fluorouracil, irinotecan, and leucovorin.[1]
The study brief also states that the randomized cohort was meant to test the efficacy, or early treatment effect, of Magrolimab with bevacizumab and FOLFIRI in this patient group.[1]
Who participated
The target population was people with previously treated advanced inoperable metastatic colorectal cancer.[1] In simple terms, this means the cancer had already been treated before, had spread, and could not be removed with surgery.[1]
The trial data provided here do not list more detailed eligibility rules such as age limits, test results, or prior treatment requirements.[1]
What the trial measured
The safety run-in cohort measured dose-limiting toxicities (DLTs), which are side effects serious enough to limit treatment, during the first 28 days after the first dose.[1] It also measured adverse events (AEs), which are unwanted medical problems during the study, and laboratory abnormalities, which are unusual blood test or lab results, for up to 3 years.[1]
The randomized cohort measured progression-free survival (PFS), which is the time from randomization until the cancer gets worse or the person dies from any cause, whichever happens first.[1] PFS was assessed by the investigator using RECIST 1.1, a standard way to measure cancer response on scans.[1]
Trial status and size
This trial is listed as Completed and enrolled 127 participants.[1] The study focused on a single cancer type, so the findings apply to a specific group of patients with metastatic colorectal cancer rather than to all cancers.[1]
