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NCT04827576: ELEVATELung&UC

Study of Magrolimab in Patients With Solid Tumors

Terminated Phase 2 Results posted Last updated 8 May 2025
What this trial tests

Phase 2 trial testing Magrolimab in Solid Tumor in 106 participants. Terminated before completion.

Timeline
1 October 2021
Primary endpoint
1 October 2024
1 October 2024

Quick facts

Lead sponsorGilead Sciences
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment106
Start date1 October 2021
Primary completion1 October 2024
Estimated completion1 October 2024
Sites49 locations across France, United Kingdom, Poland, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Gilead Sciences — full company profile →

Who can join

18 and older, any sex, with Solid Tumor. 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 Experiencing Treatment-Emergent Adverse Events (TEAEs) Primary · First dose date up to 113 weeks plus 30 days

TEAEs were defined as any adverse events (AE) not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. The TEAE reporting period is defined as the period from the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment or the day before initiation of subsequent antineoplastic therapy, whichever comes first. An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational

GroupValue95% CI
Safety Run-in Cohort 1 (Magrolimab + Docetaxel)100.0
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)100.0
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)100.0
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)100.0
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities Primary · First dose date up to 113 weeks plus 30 days

Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days and prior to the day of initiation of subsequent anti-cancer therapy. Percentages were rounded off.

Any Grade
GroupValue95% CI
Safety Run-in Cohort 1 (Magrolimab + Docetaxel)100
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)100
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)100
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)100
Grade 3 or Higher
GroupValue95% CI
Safety Run-in Cohort 1 (Magrolimab + Docetaxel)77.8
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)82.8
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)92.3
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)78.6
Objective Response Rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c) Primary · Up to 90 Weeks

ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR), as measured by RECIST version 1.1, as determined by investigator assessment. 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 method was used in outcome measure analysis. Percentages were rounded-off.

GroupValue95% CI
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)17.25.8 – 35.8
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)3.80.1 – 19.6
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)4.80.6 – 16.2
Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c) Secondary · Up to 117 Weeks

PFS was defined as the interval from the first dosing date of any study drug to the earlier date of the first documentation of objective disease progression (PD) by investigator assessment per RECIST, Version 1.1, or death from any cause. PD is 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. (the appearance of one or more new lesions was als

GroupValue95% CI
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)4.22.0 – 8.0
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)2.72.1 – 4.0
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)2.22.0 – 3.9
Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c) Secondary · Up to 117 Weeks

DOR was defined as time from first documentation of CR or PR to the earliest date of documented PD, per RECIST, Version 1.1, or death from any cause, whichever occurs first, as determined by investigator assessment. CR and PR are defined in outcome measure #3 and PD is defined in outcome measure #4. KM Estimates were used in outcome measure analysis.

GroupValue95% CI
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)7.63.7 – NA
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)NANA – NA
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)4.74.6 – NA
Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c) Secondary · Up to 117 Weeks

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

GroupValue95% CI
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)9.85.2 – NA
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)7.64.7 – 13.7
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)6.43.9 – 8.3
Serum Concentration of Magrolimab Secondary · Day 1, Day 8 Predose, Day 8 1-Hour Postdose, Day 22, Day 43 Predose, Day 43 1-Hour Postdose, Day 85, Day 127, Day 190 and Day 253 Predose
Day 1 Predose
GroupValue95% CI
Safety Run-in Cohort 1 (Magrolimab + Docetaxel)0± 0
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)0± 0
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)0± 0
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)0± 0
Day 8 Predose
GroupValue95% CI
Safety Run-in Cohort 1 (Magrolimab + Docetaxel)0± 0
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)0± 0
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)0± 0
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)0± 0
Day 8 1-Hour Postdose
GroupValue95% CI
Safety Run-in Cohort 1 (Magrolimab + Docetaxel)407± NA
Day 22 Predose
GroupValue95% CI
Safety Run-in Cohort 1 (Magrolimab + Docetaxel)460± 112
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)302± 161
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)260± 148
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)334± 134
Day 43 Predose
GroupValue95% CI
Safety Run-in Cohort 1 (Magrolimab + Docetaxel)624± 451
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)523± 195
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)439± 182
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)529± 258
Day 43 1- Hour Postdose
GroupValue95% CI
Safety Run-in Cohort 1 (Magrolimab + Docetaxel)1880± 523
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)1550± 525
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)1560± 492
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)1730± 560
Day 85 Predose
GroupValue95% CI
Safety Run-in Cohort 1 (Magrolimab + Docetaxel)415± 135
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)266± 134
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)319± 271
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)297± 181
Day 127 Predose
GroupValue95% CI
Safety Run-in Cohort 1 (Magrolimab + Docetaxel)277± 35.0
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)281± 143
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)393± 93.8
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)174± 106
Percentage of Participants Who Developed Anti-Magrolimab Antibodies Secondary · Up to 113 Weeks
GroupValue95% CI
Safety Run-in Cohort 1 (Magrolimab + Docetaxel)0
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)4.0
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)8.0
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)0

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality: Up to 117 weeks; Adverse events: Up to 113 weeks plus 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Safety Run-in Cohort 1 (Magrolimab + Docetaxel)
Serious: 5/9 (56%)
Deaths: 6/9
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)
Serious: 16/29 (55%)
Deaths: 17/29
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)
Serious: 12/26 (46%)
Deaths: 18/26
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
Serious: 18/42 (43%)
Deaths: 37/42

Serious adverse events (48 terms)

ReactionSystemSafety Run-in Cohort 1 (Ma…Phase 2 Cohort 1a, mNSCLC …Phase 2 Cohort 1b, mUC (Ma…Phase 2 Cohort 1c, mSCLC (…
Febrile neutropeniaBlood and lymphatic system disorders
PneumoniaInfections and infestations
AnaemiaBlood and lymphatic system disorders
SepsisInfections and infestations
DyspnoeaRespiratory, thoracic and mediastinal disorders
NeutropeniaBlood and lymphatic system disorders
Infusion related reactionInjury, poisoning and procedural complications
PneumonitisRespiratory, thoracic and mediastinal disorders
Pulmonary embolismRespiratory, thoracic and mediastinal disorders
Myocardial infarctionCardiac disorders
Inappropriate antidiuretic hormone secretionEndocrine disorders
DiarrhoeaGastrointestinal disorders
Gastrointestinal haemorrhageGastrointestinal disorders
Neutropenic colitisGastrointestinal disorders
Rectal haemorrhageGastrointestinal disorders
Small intestinal haemorrhageGastrointestinal disorders
FatigueGeneral disorders
HyperthermiaGeneral disorders
BronchitisInfections and infestations
Clostridium difficile infectionInfections and infestations
EncephalitisInfections and infestations
Kidney infectionInfections and infestations
Lung abscessInfections and infestations
Neutropenic sepsisInfections and infestations
Pneumocystis jirovecii pneumoniaInfections and infestations
Other adverse events (106 terms — click to expand)

ReactionSystemSafety Run-in Cohort 1 (Ma…Phase 2 Cohort 1a, mNSCLC …Phase 2 Cohort 1b, mUC (Ma…Phase 2 Cohort 1c, mSCLC (…
AnaemiaBlood and lymphatic system disorders
AstheniaGeneral disorders
DiarrhoeaGastrointestinal disorders
Decreased appetiteMetabolism and nutrition disorders
NeutropeniaBlood and lymphatic system disorders
NauseaGastrointestinal disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
FatigueGeneral disorders
PyrexiaGeneral disorders
ConstipationGastrointestinal disorders
AlopeciaSkin and subcutaneous tissue disorders
VomitingGastrointestinal disorders
Abdominal painGastrointestinal disorders
Oedema peripheralGeneral disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Back painMusculoskeletal and connective tissue disorders
DizzinessNervous system disorders
DysgeusiaNervous system disorders
HeadacheNervous system disorders
NeurotoxicityNervous system disorders
LeukopeniaBlood and lymphatic system disorders
ThrombocytopeniaBlood and lymphatic system disorders
StomatitisGastrointestinal disorders
Infusion related reactionInjury, poisoning and procedural complications
HypokalaemiaMetabolism and nutrition disorders
HyponatraemiaMetabolism and nutrition disorders
Musculoskeletal chest painMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
CoughRespiratory, thoracic and mediastinal disorders
ChillsGeneral disorders
Respiratory tract infectionInfections and infestations
Urinary tract infectionInfections and infestations
Neutrophil count decreasedInvestigations
HypoalbuminaemiaMetabolism and nutrition disorders
Pain in extremityMusculoskeletal and connective tissue disorders
PruritusSkin and subcutaneous tissue disorders
LymphopeniaBlood and lymphatic system disorders
TachycardiaCardiac disorders
DysphagiaGastrointestinal disorders
Influenza like illnessGeneral disorders

Most-reported serious reactions: Febrile neutropenia, Pneumonia, Anaemia, Sepsis, Dyspnoea, Neutropenia, Infusion related reaction, Pneumonitis.

Data from ClinicalTrials.gov NCT04827576 adverse events section.

Sponsor's own description

The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of magrolimab in combination with docetaxel in participants with solid tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Drugging the efferocytosis process: concepts and opportunities.
    Mehrotra P, Ravichandran KS. · · 2022 · cited 319× · PMID 35650427 · DOI 10.1038/s41573-022-00470-y
  2. Immunotherapy in Lung Cancer: Current Landscape and Future Directions.
    Mamdani H, Matosevic S, Khalid AB, Durm G, et al · · 2022 · cited 253× · PMID 35222404 · DOI 10.3389/fimmu.2022.823618
  3. Emerging phagocytosis checkpoints in cancer immunotherapy.
    Liu Y, Liu Y, Wang Y, Yang Y, et al · · 2023 · cited 186× · PMID 36882399 · DOI 10.1038/s41392-023-01365-z
  4. CD47-SIRPα-targeted therapeutics: status and prospects.
    Maute R, Xu J, Weissman IL. · · 2022 · cited 105× · PMID 35754851 · DOI 10.1016/j.iotech.2022.100070
  5. Progress of CD47 immune checkpoint blockade agents in anticancer therapy: a hematotoxic perspective.
    Chen YC, Shi W, Shi JJ, Lu JJ. · · 2022 · cited 50× · PMID 34609596 · DOI 10.1007/s00432-021-03815-z
  6. Don't eat me/eat me signals as a novel strategy in cancer immunotherapy.
    Khalaji A, Yancheshmeh FB, Farham F, Khorram A, et al · · 2023 · cited 44× · PMID 37822610 · DOI 10.1016/j.heliyon.2023.e20507
  7. Deciphering the role of CD47 in cancer immunotherapy.
    Liu Y, Liu Y, Weng L, Wang Y, et al · · 2024 · cited 41× · PMID 39167629 · DOI 10.1016/j.jare.2023.10.009
  8. Macrophages Are a Double-Edged Sword: Molecular Crosstalk between Tumor-Associated Macrophages and Cancer Stem Cells.
    Luo S, Yang G, Ye P, Cao N, et al · · 2022 · cited 38× · PMID 35740975 · DOI 10.3390/biom12060850

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing