In short
Clinical trials are studying Magrolimab in people with previously treated advanced, inoperable metastatic colorectal cancer. These studies look at safety, tolerability, dose finding, and whether Magrolimab added to standard treatment may help delay disease progression.
Key points
- Clinical trials of Magrolimab in the provided data focus on previously treated advanced inoperable metastatic colorectal cancer. The study is a Phase 2, randomized, open-label trial. It looks at Magrolimab given with bevacizumab and FOLFIRI compared with bevacizumab and FOLFIRI alone. Researchers are mainly checking safety, tolerability, dose-limiting toxicities, laboratory changes, and progression-free survival. The trial enrolled 127 participants and is completed.
Trial overview
This clinical trial studied Magrolimab in people with previously treated advanced inoperable metastatic colorectal cancer (mCRC). The study asked whether adding Magrolimab to standard treatment could improve outcomes and whether the treatment plan was safe and tolerable.
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. 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.
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.
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. FOLFIRI is a combination treatment made up of 5-fluorouracil, irinotecan, and leucovorin.
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.
Who participated
The target population was people with previously treated advanced inoperable metastatic colorectal cancer. In simple terms, this means the cancer had already been treated before, had spread, and could not be removed with surgery.
The trial data provided here do not list more detailed eligibility rules such as age limits, test results, or prior treatment requirements.
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. 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.
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. PFS was assessed by the investigator using RECIST 1.1, a standard way to measure cancer response on scans.
Trial status and size
This trial is listed as Completed and enrolled 127 participants. 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.