18 and older, any sex, with Solid Tumor or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Dose Limiting Toxicities (DLT)Primary· From first dose up to Day 28
DLT was defined as any Grade (GR) 3 or greater adverse event (AE) that was assessed as related to study treatment with the exceptions of:
GR 3: anemia (hemolytic anemia that is medically significant tis considered a DLT), indirect/unconjugated hyperbilirubinemia, electrolyte abnormalities, elevation in alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase that resolved to ≤ Grade 2 with supportive care within 1 week and is not associated with other clinically significant consequences; nausea, vomiting, or diarrhea that resolved to ≤ Grade 2 with supportive care within
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)Primary· From first dose date up to last dose date plus 30 days (maximum: 15.3 months)
An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE was any unfavorable and unintended sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the investigational medicinal product. A TEAE was defined as AEs worsening or occurring during or after a participant's first exposure to study drug and within 30 days after the last administration of study drug or initiation of new anticancer therapy, whichever occurred first.
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)Primary· From Screening until 38.89 months (assessed on Day 1 of Cycle 3 then every 8 weeks [Q8W] from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)
Objective response rate was defined as the percentage of participants with objective response which consisted of complete response (CR)+ partial response (PR) determined by RECIST v 1.1. CR: Disappearance of all target and all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\< 10 mm short axis). Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Group
Value
95% CI
KRASwt CRC
6.3
0.8 – 20.8
KRASm CRC
0.0
0.0 – 8.4
Pharmacokinetic (PK) Parameter: Cmax of MagrolimabSecondary· Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 1 (Cycle 1 Day 1), 8 (Cycle 1 Day 8), and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)
Cmax is defined as the maximum concentration of drug.
PK Parameter: Tmax of MagrolimabSecondary· Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)
Tmax is defined as the time (observed time point) of Cmax.
PK Parameter: AUClast of MagrolimabSecondary· Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
PK Parameter: AUCtau of MagrolimabSecondary· Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Percentage of Participants With Anti-drug Antibodies (ADA)Secondary· Baseline; post-treatment (assessed continuously up to 30 days after last dose; maximum 15.3 months )
Percentage of Participants With Positive ADA at any timepoint was reported.
Disease Control Rate (DCR) as Assessed by RECIST v1.1Secondary· From Screening until 38.89 months (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)
DCR was defined as the percentage of participants with disease control which consisted of CR+PR+SD. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters measured while on study. PD: At least a 20% increase in the sum of diamete
Group
Value
95% CI
KRASwt CRC
50.0
31.9 – 68.1
KRASm CRC
38.1
23.6 – 54.4
Duration of Response (DOR) as Assessed by RECIST v1.1Secondary· From first objective response until documented PD (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)
DOR was measured from when the first (objective) response was met (i.e., CR or PR) until the first date of objectively documented PD. Participants who did not have objectively PD was censored at their last documented progression-free date. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the sm
Group
Value
95% CI
KRASwt CRC
9.7
7.0 – 12.5
Progression Free Survival (PFS) as Assessed by RECIST v1.1Secondary· From first dose until documented PD/death (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)
PFS was measured from first dose until the first date of objectively documented PD or death. Participants who did not have objectively documented PD and not died was censored at their last documented progression-free date. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was 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. Unequivocal progression of existing non-target lesions. Kaplan
Group
Value
95% CI
KRASwt CRC
3.6
1.8 – 5.4
KRASm CRC
1.9
1.8 – 3.5
Overall Survival (OS)Secondary· From first dose until death (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)
OS was measured from first dose until death. Participants who did not die were censored at their last known alive date. Kaplan Meier estimate was used for analysis.
Group
Value
95% CI
KRASwt CRC
9.5
5.9 – 12.6
KRASm CRC
7.6
5.4 – 11.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Magrolimab 10 mg/kg
Serious: 3/9 (33%)
Deaths: 7/9
Magrolimab 20 mg/kg
Serious: 6/10 (60%)
Deaths: 8/10
Magrolimab 30 mg/kg
Serious: 10/36 (28%)
Deaths: 30/36
Magrolimab 45 mg/kg
Serious: 5/20 (25%)
Deaths: 14/20
Magrolimab Priming Dose Only
Serious: 1/3 (33%)
Deaths: 3/3
Serious adverse events (28 terms)
Reaction
System
Magrolimab 10 mg/kg
Magrolimab 20 mg/kg
Magrolimab 30 mg/kg
Magrolimab 45 mg/kg
Magrolimab Priming Dose Only
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Small intestinal obstruction
Gastrointestinal disorders
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Urinary tract infection
Infections and infestations
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Infusion related reaction
Injury, poisoning and procedural complications
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Anaemia
Blood and lymphatic system disorders
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Immune thrombocytopenic purpura
Blood and lymphatic system disorders
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Bradycardia
Cardiac disorders
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Constipation
Gastrointestinal disorders
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Enterocolitis
Gastrointestinal disorders
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Faecaloma
Gastrointestinal disorders
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Large intestinal obstruction
Gastrointestinal disorders
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Complication associated with device
General disorders
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Pyrexia
General disorders
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Bacterial sepsis
Infections and infestations
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Cystitis
Infections and infestations
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Post procedural infection
Infections and infestations
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Bilirubin conjugated increased
Investigations
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International normalised ratio increased
Investigations
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Dehydration
Metabolism and nutrition disorders
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Hyperkalaemia
Metabolism and nutrition disorders
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Hypokalaemia
Metabolism and nutrition disorders
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Pathological fracture
Musculoskeletal and connective tissue disorders
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Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Cerebrovascular accident
Nervous system disorders
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Acute kidney injury
Renal and urinary disorders
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Other adverse events (157 terms — click to expand)
The primary objectives of this study are: (Phase 1b) to investigate the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) for magrolimab in combination with cetuximab; and (Phase 2) to evaluate overall response rate (ORR) of magrolimab in combination with cetuximab in participants with Kirsten rat sarcoma 2 viral oncogene homolog (KRAS) mutant and KRAS wild-type colorectal cancer (CRC).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05367401 — A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants
· Phase 1, PHASE2
· withdrawn
NCT05823480 — Magrolimab in Combination with Azacitidine After Allogeneic HCTin Treating Patients with High-Risk AML or MDS
· Phase 1
· withdrawn
NCT05829434 — Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed AML or HR-MDS
· Phase 2
· withdrawn
NCT05807126 — Testing the Addition of Immunotherapy With Hu5F9-G4 (Magrolimab) to the Usual PARP Inhibitor, Olaparib for Treatment of
· Phase 1
· withdrawn
NCT06046482 — Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous C
· Phase 2
· terminated
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Trials by the same sponsor.
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· Phase 1
· terminated
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· Phase 2
· terminated
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· completed
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· terminated
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· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 1 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02953782.