Study of Magrolimab Given Together With FOLFIRI/Bevacizum... | NCT05330429

NCT05330429

ID	Type	Description	Link
2022-500177-13	Other Identifier	European Medicines Agency

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI	Experimental	Participants will receive magrolimab + bevacizumab + FOLFIRI as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.	Drug: Magrolimab Drug: Bevacizumab Drug: Irinotecan Drug: Fluorouracil Drug: Leucovorin
Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI	Experimental	Participants will receive magrolimab + bevacizumab + FOLFIRI as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.	Drug: Magrolimab Drug: Bevacizumab Drug: Irinotecan Drug: Fluorouracil Drug: Leucovorin
Randomized Cohort: Bevacizumab + FOLFIRI	Active Comparator	Participants will receive bevacizumab + FOLFIRI as mentioned below: Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magrolimab	Drug	Administered intravenous infusion	Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety Run-in Cohort: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0	DLT was defined as any, Grade 3 or higher hematologic toxicity including, serious hemolytic anemia, grade 4 neutropenia lasting > 7 days An event meeting Hy's Law criteria: Treatment-emergent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation (≥ 3 x ULN) and, Treatment-emergent total bilirubin elevation (> 2 x ULN), and absence of cholestasis (defined as alkaline phosphatase < 2 x ULN), and No other good explanation for the injury (hepatitis A, B, C, or other viral hepatic injury, alcohol ingestion, congestive heart failure, worsening liver metastases, hemolysis)) Grade 3 or higher nonhematologic toxicity that has worsened in severity from pretreatment baseline during the DLT-assessment period Grade 3 fatigue lasting > 7 days In the opinion of the investigator, the AE was at least possibly related to magrolimab	First dose date up to 28 days
Safety Run-in Cohort: Percentage of Participants Experiencing Adverse Events (AEs) According to the NCI-CTCAE Version 5.0	Treatment-emergent adverse events (TEAEs) were defined as any AE that begun on or after the date of first dose of study drug up to the date of last dose of study treatment plus 30 days or the day before initiation of subsequent anticancer therapy, whichever came first. An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily have a causal relationship with the treatment.	First dose date up to last dose date (up to 36 weeks) plus 30 days
Safety Run-in Cohort: Percentage of Participants Experiencing Laboratory Abnormalities According to NCI-CTCAE Version 5.0	Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade after the date of first dose of study drug up to the date of last dose of study treatment plus 30 days or the day before initiation of subsequent anticancer therapy, whichever came first.	First dose date up to last dose date (up to 36 weeks) plus 30 days

Secondary Outcomes

Measure	Description	Time Frame
Randomized Cohort: Objective Response Rate (ORR) as Determined by Investigator Assessment Using RECIST Version 1.1	ORR was defined as the percentage of participants who achieve complete response (CR) or partial response (PR) that was confirmed at least 4 weeks after initial documentation of response, as determined by investigator assessment per RECIST, Version 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Clopper-Pearson estimates were used in outcome measure analysis. Percentages were rounded off.

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Previously treated individuals with inoperable metastatic colorectal cancer (mCRC) who are ineligible for checkpoint inhibitor therapy (microsatellite instability (MSI)-H or mismatch repair deficient (dMMR) and are excluded).
Histologically or cytologically confirmed adenocarcinoma originating in the colon or rectum (excluding appendiceal and anal canal cancers) who have progressed on or after 1 prior systemic therapy in the setting where curative resection is not indicated. This therapy must have included chemotherapy based on 5-fluorouracil (5-FU) or capecitabine with oxaliplatin and either bevacizumab, or for individuals with rat sarcoma (RAS) wild-type and left-sided tumors, bevacizumab, cetuximab, or panitumumab.
Measurable disease (Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria).
Individuals must have an eastern cooperative oncology group (ECOG) performance status of 0 or 1.
Life expectancy of at least 12 weeks.
Laboratory measurements, blood counts: adequate hemoglobin, neutrophil, and platelet counts
Adequate liver function.
Adequate renal function.

Key Exclusion Criteria:

Prior anticancer therapy including chemotherapy, hormonal therapy, or investigational agents within 3 weeks or within at least 4 half-lives prior to magrolimab dosing (up to a maximum of 4 weeks), whichever is shorter.
Known v-raf murine sarcoma viral oncogene homolog B1 gene mutation (BRAF V600E) or MSI-H mutations or dMMR.
Persistent Grade 2 or more gastrointestinal bleeding.
Individuals with prior irinotecan therapy.
Clinically significant coronary artery disease or myocardial infarction within 6 months prior to inclusion.
Peripheral neuropathy of more than Grade 2 (Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0).
Known dihydropyrimidine dehydrogenase deficiency.
Acute intestinal obstruction or sub-obstruction, history of inflammatory intestinal disease or extended resection of the small intestine. Presence of a colonic prosthesis.
Unhealed wound, active gastric or duodenal ulcer, or bone fracture.
History of abdominal fistulas, trachea-oesophageal fistulas, any other Grade 4 gastrointestinal perforations, nongastrointestinal fistulas, or intra-abdominal abscesses 6 months prior to screening.
Uncontrolled arterial hypertension.
Thromboembolic event in the 6 months before inclusion (eg, transitory ischemic stroke, stroke, subarachnoid hemorrhage) except peripheral deep vein thrombosis treated with anticoagulants.
Active central nervous system (CNS) disease. Individuals with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed.
Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening.
History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.
Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
Known inherited or acquired bleeding disorders.
Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study.
Second malignancy, except treated basal cell or localized squamous skin carcinomas, or localized prostate cancer.
Uncontrolled pleural effusion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts/Locations Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope ( City of Hope National Medical Center, City of Hope Medical Center )		Duarte	California	91010	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Fakih MG, Tejani M, Ren X, Landes D, Werneke S, Curtis KK et al. 439TiP A phase II (ph2), randomized study of magrolimab with bevacizumab and FOLFIRI in previously treated patients with advanced inoperable metastatic colorectal cancer (mCRC). Annals of Oncology 2022; 33(7):S735.

Label	URL
Gilead Clinical Trials Website	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m² IV bolus on first day, followed by 2400 mg/m² over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 31, 2023	May 5, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening.

Arm/Group Information

ID	Title	Description
BG000	Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
BG001	Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
BG002	Randomized Cohort: Bevacizumab + FOLFIRI	Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00052± 11.1 BG00159± 10.1 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0006 BG00117 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0017 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0006 BG00116 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Safety Run-in Cohort: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

DLT was defined as any,

Grade 3 or higher hematologic toxicity including, serious hemolytic anemia, grade 4 neutropenia lasting > 7 days
An event meeting Hy's Law criteria:
- Treatment-emergent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation (≥ 3 x ULN) and,
- Treatment-emergent total bilirubin elevation (> 2 x ULN), and absence of cholestasis (defined as alkaline phosphatase < 2 x ULN), and
- No other good explanation for the injury (hepatitis A, B, C, or other viral hepatic injury, alcohol ingestion, congestive heart failure, worsening liver metastases, hemolysis))
Grade 3 or higher nonhematologic toxicity that has worsened in severity from pretreatment baseline during the DLT-assessment period
Grade 3 fatigue lasting > 7 days
In the opinion of the investigator, the AE was at least possibly related to magrolimab

Participants in DLT-Evaluable Analysis Set were analyzed. DLT-Evaluable Analysis Set was defined as all participants in Safety Run-in cohort who met one of the following criteria in the DLT-evaluable period (defined as the first 28 days):

Participant experienced a DLT at any time after initiation of first infusion of magrolimab.
Participant did not experience a DLT and completes at least 3 infusions of magrolimab and at least 2 doses of bevacizumab and FOLFIRI in Safety Run-in Cohort.

Posted

Count of Participants

Participants

First dose date up to 28 days

ID	Title	Description
OG000	Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.

Units	Counts
Participants	OG0006

Title

Denominators

Categories

Title	Measurements
	OG0000

Primary

Safety Run-in Cohort: Percentage of Participants Experiencing Adverse Events (AEs) According to the NCI-CTCAE Version 5.0

Treatment-emergent adverse events (TEAEs) were defined as any AE that begun on or after the date of first dose of study drug up to the date of last dose of study treatment plus 30 days or the day before initiation of subsequent anticancer therapy, whichever came first. An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily have a causal relationship with the treatment.

Participants in the Safety Run-in Cohort in the Safety Analysis Set were analyzed. The Safety Analysis Set included all participants who took at least 1 dose of any study drug.

Posted

Number

percentage of participants

First dose date up to last dose date (up to 36 weeks) plus 30 days

ID	Title	Description
OG000	Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.

Primary

Safety Run-in Cohort: Percentage of Participants Experiencing Laboratory Abnormalities According to NCI-CTCAE Version 5.0

Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade after the date of first dose of study drug up to the date of last dose of study treatment plus 30 days or the day before initiation of subsequent anticancer therapy, whichever came first.

Participants in the Safety Run-in Cohort in the Safety Analysis Set were analyzed.

Posted

Number

percentage of participants

First dose date up to last dose date (up to 36 weeks) plus 30 days

ID	Title	Description
OG000	Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.

Units	Counts
Participants

Primary

Randomized Cohort: Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

PFS was defined as the time from the date of randomization until the earliest date of documented disease progression (PD) as determined by investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1), or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Kaplan-Meier (KM) estimates were used in outcome measure analysis.

Participants in the Randomized Cohorts in the Intent-to-treat Analysis Set were analyzed. Intent-to-treat Analysis Set included all participants who were randomized in the study.

Posted

Median

95% Confidence Interval

months

Up to 83.4 weeks

ID	Title	Description
OG000	Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.

Secondary

Randomized Cohort: Objective Response Rate (ORR) as Determined by Investigator Assessment Using RECIST Version 1.1

ORR was defined as the percentage of participants who achieve complete response (CR) or partial response (PR) that was confirmed at least 4 weeks after initial documentation of response, as determined by investigator assessment per RECIST, Version 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Clopper-Pearson estimates were used in outcome measure analysis. Percentages were rounded off.

Participants in the Randomized Cohorts in the Intent-to-Treat Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 83.4 weeks

ID	Title	Description
OG000	Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.

Secondary

Randomized Cohort: Duration of Response (DOR) as Determined by Investigator Assessment Per RECIST Version 1.1

DOR was defined as time from first documentation of CR or PR to the earliest date of documented disease progression as determined by investigator assessment, per RECIST V1.1, or death from any cause, whichever occurred first. PD was defined in outcome measure #4. CR and PR were defined in outcome measure #5.

KM estimates were used in outcome measure analysis.

Participants in the Randomized Cohorts in the Intent-to-Treat Analysis Set with objective response were analyzed.

Posted

Median

95% Confidence Interval

months

Up to 83.4 weeks

ID	Title	Description
OG000	Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
OG001	Randomized Cohort: Bevacizumab + FOLFIRI	Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.

Secondary

Randomized Cohort: Overall Survival (OS)

OS was defined as time from date of randomization to death from any cause. KM estimates were used in outcome measure analysis.

Participants in the Randomized Cohort in the Intent-to-Treat Analysis Set were analyzed.

Posted

Median

95% Confidence Interval

months

Up to 83.4 weeks

ID	Title	Description
OG000	Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
OG001	Randomized Cohort: Bevacizumab + FOLFIRI	Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.

Secondary

Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score

EORTC QLQ-C30 is a quality of life (QOL) questionnaire for cancer participants, that has 30 items. 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties). Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicated a higher level of symptoms (i.e. a worse state of the participant).

Participants in the Randomized cohort in the Intent-to-treat Analysis Set with available data were analyzed. Data was collected until Cycle 8.

Posted

Mean

Standard Deviation

Score on a scale

Baseline, Day 1 of Cycles 2, 3, 4 and last cycle (Cycle 8) (Each cycle was of 28 days)

ID	Title	Description
OG000	Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.

Secondary

Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score

EQ-5D-5L was an instrument for use as a measure of health outcome. The EQ-5D-5L consisted of 2 sections: EuroQoL (5 dimensions) (EQ-5D) descriptive system and the EuroQoL visual analogue scale (EQ-VAS). EQ-5D comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Number of participants per category were reported.

Participants in the Randomized Cohort in the Intent-to-treat Analysis Set with available data were analyzed.

Posted

Count of Participants

Participants

Day 1 of Cycles 2, 3, 4 and last cycle (Cycle 8) (Each cycle is of 28 days)

ID	Title	Description
OG000	Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
OG001

Secondary

Randomized Cohort: Change From Baseline in the EuroQoL Visual Analogue Scale (EQ-VAS) Score

The EQ-VAS recorded the participants' self-rated health on a vertical VAS, where the end points were labeled "the best health you can imagine" and "the worst health you can imagine." The scale range from 0 to 100, where '100' rating denotes the best health and '0' rating denotes the worst health. The EQ-VAS is used as a quantitative measure of health outcome that reflects the participants' own judgment.

Participants in the Randomized Cohort in the Intent-to-treat Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

Units on a scale

Baseline, Day 1 of Cycles 2, 3, 4 and last cycle (Cycle 8) (Each cycle is of 28 days)

ID	Title	Description
OG000	Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
OG001	Randomized Cohort: Bevacizumab + FOLFIRI

Secondary

Randomized Cohort: Change From Baseline of the Functional Assessment of Cancer Therapy (FACT) Colorectal Symptom Index (FCSI) Score

The FCSI was a set of brief, clinically relevant, colorectal cancer symptoms for assessing symptomatic response. It comprised the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions were combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items were scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items was transformed to a 0-100 scale, and the average for each of the 3 subscales was calculated; high scores illustrated an improved state.

Participants in the Randomized Cohort in the Intent-to-Treat Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

Score on a scale

Baseline, Day 1 of Cycles 2, 3, 4 and last cycle (Cycle 8) (Each cycle is of 28 days)

ID	Title	Description
OG000	Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.

Secondary

Safety Run-in and Randomized Cohorts: Magrolimab Concentration Versus Time

Participants in the Pharmacokinetic (PK) Analysis Set with available data were analyzed. The PK Analysis Set was defined as all participants who received any amount of magrolimab and have at least 1 measurable posttreatment serum concentration of magrolimab.

Posted

Mean

Standard Deviation

μg/mL

Predose: Day 15, 29, 57, 113 and 169; Postdose: Day 57 (1 hour)

ID	Title	Description
OG000	Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
OG001	Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.

Secondary

Safety Run-in and Randomized Cohorts: Percentage of Participants With Antidrug Antibodies (ADA) to Magrolimab

Participants in the Immunogenicity Analysis Set with available data were analyzed. Immunogenicity Analysis Set included all participants who received any amount of magrolimab and had at least 1 evaluable anti-drug antibody test result.

Posted

Number

percentage of participants

Up to 36 weeks

ID	Title	Description
OG000	Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
OG001	Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.	6	10	5	10	10	10
EG001	Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI	Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.	2	44	16	44	43	44
EG002	Randomized Cohort: Bevacizumab + FOLFIRI	Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below: Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. FOLFIRI (Irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 IV bolus on first day, followed by 2400 mg/m^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.	5	23	6	21	19	21

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0012 affected44 at risk EG0020 affected21 at risk
Cardiac arrest	Cardiac disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Cardiac failure acute	Cardiac disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk
Colitis	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0012 affected44 at risk EG0020 affected21 at risk
Enteritis	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Malignant gastrointestinal obstruction	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk
Proctalgia	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Rectourethral fistula	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk
Pyrexia	General disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Anal abscess	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk
Bronchitis	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Covid-19	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Cystitis	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Herpes zoster	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Perirectal abscess	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Pneumonia	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Sepsis	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected44 at risk EG0020 affected21 at risk
Skin infection	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Tooth abscess	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Vascular device infection	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Liver function test abnormal	Investigations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk
Ischaemic stroke	Nervous system disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Deep vein thrombosis	Vascular disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 27.0	Systematic Assessment	EG0006 affected10 at risk EG00125 affected44 at risk EG0024 affected21 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 27.0	Systematic Assessment	EG0003 affected10 at risk EG00113 affected44 at risk EG0025 affected21 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 27.0	Systematic Assessment	EG0002 affected10 at risk EG0014 affected44 at risk EG0020 affected21 at risk
Dry eye	Eye disorders	MedDRA Version 27.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Lacrimation increased	Eye disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Vitreous floaters	Eye disorders	MedDRA Version 27.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0013 affected44 at risk EG0022 affected21 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0002 affected10 at risk EG00110 affected44 at risk EG0024 affected21 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0004 affected10 at risk EG0019 affected44 at risk EG0025 affected21 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0006 affected10 at risk EG00125 affected44 at risk EG00211 affected21 at risk
Dry mouth	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0013 affected44 at risk EG0021 affected21 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0014 affected44 at risk EG0020 affected21 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Gingival pain	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk
Haematochezia	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0022 affected21 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0009 affected10 at risk EG00123 affected44 at risk EG00210 affected21 at risk
Proctalgia	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Rectal tenesmus	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0005 affected10 at risk EG00116 affected44 at risk EG0022 affected21 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0004 affected10 at risk EG00114 affected44 at risk EG0025 affected21 at risk
Asthenia	General disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0019 affected44 at risk EG0023 affected21 at risk
Chest pain	General disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Chills	General disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0016 affected44 at risk EG0021 affected21 at risk
Fatigue	General disorders	MedDRA Version 27.0	Systematic Assessment	EG0008 affected10 at risk EG00119 affected44 at risk EG0026 affected21 at risk
Influenza like illness	General disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected44 at risk EG0022 affected21 at risk
Malaise	General disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Mucosal inflammation	General disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Oedema peripheral	General disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0013 affected44 at risk EG0022 affected21 at risk
Pyrexia	General disorders	MedDRA Version 27.0	Systematic Assessment	EG0002 affected10 at risk EG0017 affected44 at risk EG0024 affected21 at risk
Subcapsular hepatic haematoma	Hepatobiliary disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Covid-19	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected44 at risk EG0021 affected21 at risk
Gingivitis	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0002 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Skin infection	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0022 affected21 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA Version 27.0	Systematic Assessment	EG0004 affected10 at risk EG0014 affected44 at risk EG0020 affected21 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected44 at risk EG0022 affected21 at risk
Stoma complication	Injury, poisoning and procedural complications	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 27.0	Systematic Assessment	EG0002 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Aspartate aminotransferase increased	Investigations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected44 at risk EG0021 affected21 at risk
Lymphocyte count decreased	Investigations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0016 affected44 at risk EG0021 affected21 at risk
Neutrophil count decreased	Investigations	MedDRA Version 27.0	Systematic Assessment	EG0004 affected10 at risk EG00110 affected44 at risk EG0025 affected21 at risk
Platelet count decreased	Investigations	MedDRA Version 27.0	Systematic Assessment	EG0003 affected10 at risk EG0017 affected44 at risk EG0021 affected21 at risk
Weight decreased	Investigations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0016 affected44 at risk EG0024 affected21 at risk
Weight increased	Investigations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
White blood cell count decreased	Investigations	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0019 affected44 at risk EG0022 affected21 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 27.0	Systematic Assessment	EG0004 affected10 at risk EG00115 affected44 at risk EG0026 affected21 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 27.0	Systematic Assessment	EG0002 affected10 at risk EG0013 affected44 at risk EG0021 affected21 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected44 at risk EG0022 affected21 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0016 affected44 at risk EG0022 affected21 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0013 affected44 at risk EG0021 affected21 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0013 affected44 at risk EG0020 affected21 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0013 affected44 at risk EG0020 affected21 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0015 affected44 at risk EG0022 affected21 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0013 affected44 at risk EG0021 affected21 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected44 at risk EG0020 affected21 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0012 affected44 at risk EG0022 affected21 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0013 affected44 at risk EG0020 affected21 at risk
Dizziness	Nervous system disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0016 affected44 at risk EG0021 affected21 at risk
Dysgeusia	Nervous system disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0014 affected44 at risk EG0022 affected21 at risk
Headache	Nervous system disorders	MedDRA Version 27.0	Systematic Assessment	EG0004 affected10 at risk EG00115 affected44 at risk EG0020 affected21 at risk
Lethargy	Nervous system disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected44 at risk EG0022 affected21 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0014 affected44 at risk EG0021 affected21 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected44 at risk EG0020 affected21 at risk
Tremor	Nervous system disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Anxiety	Psychiatric disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Insomnia	Psychiatric disorders	MedDRA Version 27.0	Systematic Assessment	EG0002 affected10 at risk EG0016 affected44 at risk EG0022 affected21 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Dysuria	Renal and urinary disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0013 affected44 at risk EG0020 affected21 at risk
Urinary retention	Renal and urinary disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0021 affected21 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0017 affected44 at risk EG0023 affected21 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0015 affected44 at risk EG0025 affected21 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0016 affected44 at risk EG0025 affected21 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0002 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0023 affected21 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0014 affected44 at risk EG0021 affected21 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0019 affected44 at risk EG0027 affected21 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected44 at risk EG0021 affected21 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0013 affected44 at risk EG0021 affected21 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0002 affected10 at risk EG0011 affected44 at risk EG0021 affected21 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0014 affected44 at risk EG0021 affected21 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected44 at risk EG0022 affected21 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Deep vein thrombosis	Vascular disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected44 at risk EG0020 affected21 at risk
Flushing	Vascular disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected44 at risk EG0020 affected21 at risk
Hypertension	Vascular disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0014 affected44 at risk EG0023 affected21 at risk
Hypotension	Vascular disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected44 at risk EG0021 affected21 at risk

First MCP Posted Date

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
C000629291	magrolimab
D000068258	Bevacizumab
D000077146	Irinotecan
D005472	Fluorouracil
D002955	Leucovorin

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003067	Coenzymes
D045762	Enzymes and Coenzymes

Units	Counts
Participants	OG00010

Standard deviation cannot be calculated for one participant.