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NCT02953782

Study of Magrolimab (Hu5F9-G4) in Combination With Cetuximab in Participants With Solid Tumors and Advanced Colorectal Cancer

Completed Phase 1, PHASE2 Results posted Last updated 1 March 2021
What this trial tests

Phase 1, PHASE2 trial testing Magrolimab in Solid Tumor in 78 participants. Completed in 10 February 2020.

Timeline
2 November 2016
Primary endpoint
10 February 2020
10 February 2020

Quick facts

Lead sponsorGilead Sciences
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment78
Start date2 November 2016
Primary completion10 February 2020
Estimated completion10 February 2020
Sites8 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Gilead Sciences — full company profile →

Who can join

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

GroupValue95% CI
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^216.7
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^20.0
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^20.0
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^214.3
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^20.0
Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^20.0
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.

GroupValue95% CI
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2100.0
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2100.0
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2100.0
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2100.0
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2100.0
Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2100.0
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2100.0
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2100.0
Magrolimab Priming Dose Only100.0
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.

GroupValue95% CI
KRASwt CRC6.30.8 – 20.8
KRASm CRC0.00.0 – 8.4
Pharmacokinetic (PK) Parameter: Cmax of Magrolimab Secondary · 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.

Day 1 (Cycle 1 Day 1)
GroupValue95% CI
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^21.04± 0.769
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^20.629± 0.437
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^20.662± 0.374
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^20.432± 0.173
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^20.517± 0.311
Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^20.479± 0.170
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^20.559± 0.254
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^20.525± 0.296
Day 8 (Cycle 1 Day 8)
GroupValue95% CI
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2209± 82.0
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2230± 54.6
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2455± 105
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2558± 168
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^21100± 287
Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2513± 148
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2616± 121
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2901± 131
Day 29 (Cycle 2 Day 1)
GroupValue95% CI
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2312± 121
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2352± 68.4
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2728± 207
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2982± 182
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^22140± 590
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2775± 110
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^21790± 49.5
PK Parameter: Tmax of Magrolimab Secondary · 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.

Day 8 (Cycle 1 Day 8)
GroupValue95% CI
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^20.100.09 – 0.12
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^20.120.09 – 0.13
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^20.120.12 – 6.94
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^20.140.12 – 0.85
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^20.130.12 – 3.90
Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^20.120.08 – 6.82
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^20.130.12 – 0.17
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^20.120.11 – 6.99
Day 29 (Cycle 2 Day 1)
GroupValue95% CI
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^20.940.10 – 1.09
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^20.130.12 – 0.13
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^20.130.12 – 0.96
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^20.130.10 – 0.15
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^20.120.12 – 0.13
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^20.140.14 – 0.14
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^20.120.12 – 0.12
PK Parameter: AUClast of Magrolimab Secondary · 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.

Day 8 (Cycle 1 Day 8)
GroupValue95% CI
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2676± 75.3
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^21530± 513
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^22140± 726
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^22920± 600
Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^21930
Day 29 (Cycle 2 Day 1)
GroupValue95% CI
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^21420± 711
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^21560± 413
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^23330± 1270
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^24480± 1220
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^27340± 2380
PK Parameter: AUCtau of Magrolimab Secondary · 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).

Day 8 (Cycle 1 Day 8)
GroupValue95% CI
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2676± 75.3
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^21630± 649
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^22140± 726
Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^21930
Day 29 (Cycle 2 Day 1)
GroupValue95% CI
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^21640± 604
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^21560± 413
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^23630± 1040
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^24480± 1220
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^28770± 1120
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.

Baseline ADA
GroupValue95% CI
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^20.00
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^20.00
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^20.00
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^214.3
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^20.00
Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^26.3
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^20.00
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^20.00
Post-Treatment ADA
GroupValue95% CI
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^233.3
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^20.00
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^20.00
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^20.00
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^20.00
Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^26.3
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^213.3
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^20.00
Overall ADA
GroupValue95% CI
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^233.3
Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^20.00
Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^20.00
Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^214.3
Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^20.00
Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^212.5
Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^213.3
Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^20.00
Disease Control Rate (DCR) as Assessed by RECIST v1.1 Secondary · 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

GroupValue95% CI
KRASwt CRC50.031.9 – 68.1
KRASm CRC38.123.6 – 54.4
Duration of Response (DOR) as Assessed by RECIST v1.1 Secondary · 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

GroupValue95% CI
KRASwt CRC9.77.0 – 12.5
Progression Free Survival (PFS) as Assessed by RECIST v1.1 Secondary · 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

GroupValue95% CI
KRASwt CRC3.61.8 – 5.4
KRASm CRC1.91.8 – 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.

GroupValue95% CI
KRASwt CRC9.55.9 – 12.6
KRASm CRC7.65.4 – 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)

ReactionSystemMagrolimab 10 mg/kgMagrolimab 20 mg/kgMagrolimab 30 mg/kgMagrolimab 45 mg/kgMagrolimab Priming Dose Only
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestinal obstructionGastrointestinal disorders
Urinary tract infectionInfections and infestations
Infusion related reactionInjury, poisoning and procedural complications
AnaemiaBlood and lymphatic system disorders
Immune thrombocytopenic purpuraBlood and lymphatic system disorders
BradycardiaCardiac disorders
ConstipationGastrointestinal disorders
EnterocolitisGastrointestinal disorders
FaecalomaGastrointestinal disorders
Large intestinal obstructionGastrointestinal disorders
Complication associated with deviceGeneral disorders
PyrexiaGeneral disorders
Bacterial sepsisInfections and infestations
CystitisInfections and infestations
Post procedural infectionInfections and infestations
Bilirubin conjugated increasedInvestigations
International normalised ratio increasedInvestigations
DehydrationMetabolism and nutrition disorders
HyperkalaemiaMetabolism and nutrition disorders
HypokalaemiaMetabolism and nutrition disorders
Pathological fractureMusculoskeletal and connective tissue disorders
Tumour painNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebrovascular accidentNervous system disorders
Acute kidney injuryRenal and urinary disorders
Other adverse events (157 terms — click to expand)

ReactionSystemMagrolimab 10 mg/kgMagrolimab 20 mg/kgMagrolimab 30 mg/kgMagrolimab 45 mg/kgMagrolimab Priming Dose Only
FatigueGeneral disorders
HeadacheNervous system disorders
NauseaGastrointestinal disorders
Dermatitis acneiformSkin and subcutaneous tissue disorders
PyrexiaGeneral disorders
Infusion related reactionInjury, poisoning and procedural complications
AnaemiaBlood and lymphatic system disorders
VomitingGastrointestinal disorders
ChillsGeneral disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
HypomagnesaemiaMetabolism and nutrition disorders
Dry skinSkin and subcutaneous tissue disorders
DiarrhoeaGastrointestinal disorders
Decreased appetiteMetabolism and nutrition disorders
StomatitisGastrointestinal disorders
PruritusSkin and subcutaneous tissue disorders
RashSkin and subcutaneous tissue disorders
Rash maculo-papularSkin and subcutaneous tissue disorders
Abdominal painGastrointestinal disorders
ConstipationGastrointestinal disorders
Aspartate aminotransferase increasedInvestigations
Blood bilirubin increasedInvestigations
HypokalaemiaMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
CoughRespiratory, thoracic and mediastinal disorders
Abdominal distensionGastrointestinal disorders
Alanine aminotransferase increasedInvestigations
Lymphocyte count decreasedInvestigations
DehydrationMetabolism and nutrition disorders
Muscle spasmsMusculoskeletal and connective tissue disorders
DepressionPsychiatric disorders
Rash pruriticSkin and subcutaneous tissue disorders
Vision blurredEye disorders
Vitreous floatersEye disorders
Abdominal pain upperGastrointestinal disorders
Non-cardiac chest painGeneral disorders
PainGeneral disorders
Weight decreasedInvestigations
Muscular weaknessMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Malignant neoplasm progression, Small intestinal obstruction, Urinary tract infection, Infusion related reaction, Anaemia, Immune thrombocytopenic purpura, Bradycardia, Constipation.

Data from ClinicalTrials.gov NCT02953782 adverse events section.

Sponsor's own description

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):

  1. Tumor microenvironment as a therapeutic target in cancer.
    Xiao Y, Yu D. · · 2021 · cited 1438× · PMID 33259885 · DOI 10.1016/j.pharmthera.2020.107753
  2. Macrophages as tools and targets in cancer therapy.
    Mantovani A, Allavena P, Marchesi F, Garlanda C. · · 2022 · cited 1279× · PMID 35974096 · DOI 10.1038/s41573-022-00520-5
  3. Phagocytosis checkpoints as new targets for cancer immunotherapy.
    Feng M, Jiang W, Kim BYS, Zhang CC, et al · · 2019 · cited 729× · PMID 31462760 · DOI 10.1038/s41568-019-0183-z
  4. Progress in tumor-associated macrophage (TAM)-targeted therapeutics.
    Ngambenjawong C, Gustafson HH, Pun SH. · · 2017 · cited 659× · PMID 28449873 · DOI 10.1016/j.addr.2017.04.010
  5. First-in-Human, First-in-Class Phase I Trial of the Anti-CD47 Antibody Hu5F9-G4 in Patients With Advanced Cancers.
    Sikic BI, Lakhani N, Patnaik A, Shah SA, et al · · 2019 · cited 484× · PMID 30811285 · DOI 10.1200/jco.18.02018
  6. Targeting macrophages in cancer immunotherapy.
    Duan Z, Luo Y. · · 2021 · cited 462× · PMID 33767177 · DOI 10.1038/s41392-021-00506-6
  7. Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
    Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038
  8. Drugging the efferocytosis process: concepts and opportunities.
    Mehrotra P, Ravichandran KS. · · 2022 · cited 319× · PMID 35650427 · DOI 10.1038/s41573-022-00470-y

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