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Solid TumorPhase 2ELEVATELung&UCNCT04827576

Study of Magrolimab in Patients With Solid Tumors

A Phase 2 study testing Magrolimab and Docetaxel in people with Solid Tumor, run by Gilead Sciences at 49 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
Magrolimab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
49 sitesin 5 countries
Study dates
1 Oct 2021to 1 Oct 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individual must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Adequate blood counts.
  • Adequate renal function.
  • Adequate liver function.
  • Pretreatment blood cross-match completed.
  • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
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  • Measurable disease according to response evaluation criteria in solid tumours (RECIST) version 1.1
  • Cohort-Specific Inclusion Criteria:
  • Safety Run-in Cohort 1: Individuals with metastatic advanced solid tumors who have had at least 1 prior line of systemic anticancer therapy (metastatic non-small cell lung cancer (mNSCLC) and metastatic small cell lung cancer (mSCLC)) in a locally advanced/metastatic setting, or 2 prior lines of systemic anticancer therapy (metastatic urothelial cancer (mUC)) in a locally advanced/metastatic setting, and not more than 3 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting.
  • Phase 2 Cohort 1a (mNSCLC): Individuals with NSCLC who have had treatment with platinum-based chemotherapy and immune checkpoint inhibitor therapy in a locally advanced/metastatic setting, either in combination or sequentially (unless not eligible for one of these therapies) are eligible. At least 1 prior line of systemic anticancer therapy in a locally advanced/metastatic setting is required and not more than 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded. Individuals whose tumors have genomic alterations are excluded.
  • Phase 2 Cohort 1b (mUC): Individuals with UC who have had prior treatment with systemic chemotherapy and immune checkpoint inhibitor therapy in a locally advanced/metastatic setting (unless not eligible for one of these therapies) are eligible. At least 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are required and not more than 3 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded.
  • Phase 2 Cohort 1c (mSCLC): Individuals with SCLC who have had prior treatment with platinum-based chemotherapy and/or immune checkpoint inhibitor therapy are eligible. At least 1 prior line of systemic anticancer therapy in a locally advanced/metastatic setting is required and not more than 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded.
  • Note: Maintenance therapies are not counted as separate lines of therapy.

Who cannot join

  • Positive serum pregnancy test.
  • Breastfeeding female.
  • 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 red blood cell transfusions during the 4-week period prior to screening. RBC transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criteria.
  • 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.
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  • Prior treatment with cluster of differentiation (CD)47 or signal regulatory protein alpha-targeting agents.
  • Current participation in another interventional clinical study.
  • 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. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV.
  • Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anticancer therapies and who are in complete remission for over 3 years.
  • Known active or chronic hepatitis B or C infection or human immunodeficiency virus.
  • Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted.
  • Note: Localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormone releasing hormone agonists for prostate or breast cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappa B ligand (RANKL) inhibitors are not criteria for exclusion.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

49 sites in 5 countries.

49 sites in 5 countries

United States21 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University Center and Blood Center,LLC.

    Athens, Georgia, 30607

  • Saint Alphonsus Cancer Institute Caldwell

    Caldwell, Idaho, 83605

  • Charleston Oncology

    Charleston, South Carolina, 29414

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • MD Anderson Cancer Center

    Dallas, Texas, 77030

  • University of Miami

    Deerfield Beach, Florida, 33064

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Cancer Treatment Centers of America

    Goodyear, Arizona, 85338

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Comprehensive Cancer Centers of Nevada- Twain Office

    Las Vegas, Nevada, 89169

  • Southeastern regional Medical Center

    Newnan, Georgia, 30265

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Virginia Piper Cancer Center (Alliant Health)

    Saint Paul, Minnesota, 55102

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

  • Providence Saint John's Health Center

    Santa Monica, California, 90404

  • St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • Orchard Healthcare Research Inc

    Skokie, Illinois, 60077

  • Medical Oncology Associates,PS (dba Summit Cancer Center) (includes IP Shipment)

    Spokane, Washington, 99208

  • Tallahassee Memorial Healthcare Cancer Center

    Tallahassee, Florida, 32308

Other trials in United States

Spain14 sites

  • Instituto de Investigacion Oncologica Vall de Hebron

    Barcelona, 08035

  • Hospital del Mar

    Barcelona, 8003

  • Hospital Quironsalud Barcelona

    Barcelona, 8023

  • Hospital De La Santa Creu I Sant Pau

    Barcelona, 8041

  • Hospital Universitario de Jaen

    Jaén, 23007

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital HM Sanchinarro

    Madrid, 28050

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

France9 sites

  • Institut Bergonie

    Bordeaux, 33000

  • Centre Georges François Leclerc

    Dijon, 21079

  • Centre Hospitalier Regional Universitaire de Lille

    Lille, 59037

  • Centre LÃon BÃrard Centre RÃgional de Lutte Contre Le Cancer

    Lyon, 69373

  • Hopital Nord AP-HM

    Marseille, 13005

  • Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site Est

    Nice, 6189

  • Hôpital de la Pitié Salpétrière

    Paris, 75013

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69310

  • Institut de Cancérologie de l'Ouest (ICO) - Saint-Herblain

    Saint-Herblain

Other trials in France

Poland3 sites

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85-796

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-513

  • Wojewodzki Szpital Specjalistyczny w Siedlcach

    Siedlce, 08-110

Other trials in Poland

United Kingdom2 sites

  • Barts Health NHS Trust

    London, EC1A 7BE

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT

Other trials in United Kingdom

About this study

Official title: A Phase 2, Multi-Arm Study of Magrolimab in Patients With Solid Tumors

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.

Read the detailed description

This study will consist of a Safety Run-in Cohort 1 (magrolimab + docetaxel combination). After completion of the Safety Run-in Cohort 1, Phase 2 Cohort 1 will occur as follows:

  • Phase 2 Cohort 1: a cohort of participants with solid tumors (metastatic non-small cell lung cancer (mNSCLC) (Phase 2 Cohort 1a), metastatic urothelial cancer (mUC) (Phase 2 Cohort 1b), and metastatic small cell lung cancer (mSCLC) (Phase 2 Cohort 1c).
Conditions
Solid Tumor
Being tested
Magrolimab, Docetaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MagrolimabDrug

    Also called GS-4721

    Administered intravenously

  • DocetaxelDrug

    Also called Taxotere®

    Administered intravenously

Study groups in NCT04827576
Study groupRoleWhat they receive
Safety Run-in Cohort 1 (Magrolimab + Docetaxel)ExperimentalParticipants with solid tumors (including metastatic non small cell lung cancer (mNSCLC), metastatic urothelial cancer (mUC), and metastatic small cell lung cancer (mSCLC)) will receive 1 mg/kg magrolimab intravenously (IV) on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 113 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 113 weeks; each cycle length = 21 days.
Receives: Drug: Magrolimab; Drug: Docetaxel
Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)ExperimentalParticipants with mNSCLC will receive 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 90 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 69 weeks; each cycle length = 21 days.
Receives: Drug: Magrolimab; Drug: Docetaxel
Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)ExperimentalParticipants with mUC will receive 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 68 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 68 weeks; each cycle length = 21 days.
Receives: Drug: Magrolimab; Drug: Docetaxel
Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)ExperimentalParticipants with mSCLC will receive 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days.
Receives: Drug: Magrolimab; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

    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 product or other protocol-imposed intervention, regardless of attribution.

    Measured: First dose date up to 113 weeks plus 30 days

  2. Percentage of Participants With Treatment-Emergent Laboratory Abnormalities

    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.

    Measured: First dose date up to 113 weeks plus 30 days

  3. Objective Response Rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c)

    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.

    Measured: Up to 90 Weeks

Secondary outcomes (5)

  1. Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c)

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

    Measured: Up to 117 Weeks

  2. Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c)

    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.

    Measured: Up to 117 Weeks

  3. Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c)

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

    Measured: Up to 117 Weeks

  4. Serum Concentration of Magrolimab

    Measured: 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

  5. Percentage of Participants Who Developed Anti-Magrolimab Antibodies

    Measured: Up to 113 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start1 Oct 2021
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2024

Why it stopped: Sponsor decision to terminate study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04827576
Sponsor's protocol ID
GS-US-548-5918
Other IDs
2020-005265-14
Acronym
ELEVATELung&UC
Status last verified
Apr 2025
First submitted
30 Mar 2021
Last updated
8 May 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Van Burren N, U'Ren L, Song K, Liu Y, Correa P, Tang S, et al. Biomarker analysis of magrolimab plus docetaxel in patients with 2L+ mNSCLC from ELEVATE Lung and UC, a Phase 2 multicohort study [Abstract]. J Immunother Cancer. 2024;12. doi:10.1136/jitc- 2024-SITC2024.0184.

  • Van Burren N, U'Ren L, Song K, Liu Y, Correa P, Tang S, et al. Biomarker analysis of magrolimab plus docetaxel in patients with 2L+ mNSCLC from ELEVATE Lung and UC, a Phase 2 multicohort study. Poster presented at: 2024 Society for Immunotherapy of Cancer (SITC); 2024 Nov 6-10; Houston, TX, USA.

  • Juan-Vidal O, Fang B, Paz-Ares LG, Ortega Granado AL, Vicuna BD, Bodnar L, et al. Magrolimab + docetaxel in previously treated patients with metastatic non-small cell lung cancer [Abstract]. J Immunother Cancer. 2024;12. doi:10.1136/jitc-2024-SITC2024.0604.

  • Juan-Vidal O, Fang B, Paz-Ares LG, Ortega Granado AL, Vicuna BD, Bodnar L, et al. Magrolimab + docetaxel in previously treated patients with metastatic non-small cell lung cancer. Poster presented at: 2024 Society for Immunotherapy of Cancer (SITC); 2024 Nov 6-10; Houston, TX, USA.

  • Vaishampayan UN, Puri S, Kummar S, Perez JM, Italiano A, Shao J, et al. A Phase 2 multiarm study of magrolimab in combination with docetaxel in patients with locally advanced or metastatic solid tumors: ELEVATE-Lung and UC. J Clin Oncol. 2023;41(16_suppl):TPS9142-TPS9142.

  • Subbiah V, Vaishampayan UN, Puri S, Lin L, Chao M, Ramsingh G, et al. A Phase 2, multiarm study of anti-CD47 antibody, magrolimab, in combination with docetaxel in patients with locally advanced or metastatic solid tumors. J Clin Oncol. 2022;40(6_suppl):TPS584-TPS584.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Magrolimab and Docetaxel in people with Solid Tumor, run by Gilead Sciences at 49 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Spain, France, Poland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) (time frame: First dose date up to 113 weeks plus 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04827576, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.

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