Study of Magrolimab in Patients With Solid Tumors (ELEVATELung&UC)

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.

Study Overview

• Status: Terminated
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Magrolimab; Drug: Docetaxel

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).

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Institut Bergonie
  • Dijon, France, 21079
    • Centre Georges Francois Leclerc
  • Lille, France, 59037
    • Centre Hospitalier REgional Universitaire de Lille
  • Lyon, France, 69373
    • Centre LÃon BÃrard Centre RÃgional de Lutte Contre Le Cancer
  • Marseille, France, 13005
    • Hopital Nord AP-HM
  • Nice, France, 6189
    • Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site Est
  • Paris, France, 75013
    • Hopital de La Pitie Salpetriere
  • Pierre-benite, France, 69310
    • Centre Hospitalier Lyon-Sud
  • Saint Herblain, France
    • Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain
• Poland
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
  • Lodz, Poland, 93-513
    • Instytut Centrum Zdrowia Matki Polki
  • Siedlce, Poland, 08-110
    • Wojewodzki Szpital Specjalistyczny w Siedlcach
• Spain
  • Barcelona, Spain, 8041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 8003
    • Hospital del Mar
  • Barcelona, Spain, 08035
    • Instituto de Investigacion Oncologica Vall de Hebron
  • Barcelona, Spain, 8023
    • Hospital Quironsalud Barcelona
  • Jaen, Spain, 23007
    • Hospital Universitario de Jaen
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center
  • Madrid, Spain, 28050
    • Hospital HM Sanchinarro
  • Malaga, Spain, 29010
    • Hospital Regional Universitario de Málaga
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen Del Rocio
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Barts Health Nhs Trust
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas' NHS Foundation Trust
• United States
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Cancer Treatment Centers of America
  • California
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • Santa Monica, California, United States, 90404
      • Providence Saint John's Health Center
    • Santa Rosa, California, United States, 95403
      • St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • University of Miami
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Healthcare Cancer Center
  • Georgia
    • Athens, Georgia, United States, 30607
      • University Center and Blood Center,LLC.
    • Newnan, Georgia, United States, 30265
      • Southeastern Regional Medical Center
  • Idaho
    • Caldwell, Idaho, United States, 83605
      • Saint Alphonsus Cancer Institute Caldwell
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Orchard Healthcare Research Inc
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals & Clinics
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • Virginia Piper Cancer Center (Alliant Health)
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada- Twain Office
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Astera Cancer Care
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Oncology
  • Texas
    • Dallas, Texas, United States, 75230
      • Mary Crowley Cancer Research
    • Dallas, Texas, United States, 77030
      • MD Anderson Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute, University of Utah
  • Washington
    • Spokane, Washington, United States, 99208
      • Medical Oncology Associates,PS (dba Summit Cancer Center) (includes IP Shipment)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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.
• 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.

Key Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safety Run-in Cohort 1 (Magrolimab + Docetaxel); Participants 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.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Docetaxel; Administered intravenously; Other Names: Taxotere®
Experimental: Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel); Participants 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.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Docetaxel; Administered intravenously; Other Names: Taxotere®
Experimental: Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel); Participants 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.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Docetaxel; Administered intravenously; Other Names: Taxotere®
Experimental: Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel); Participants 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.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Docetaxel; Administered intravenously; Other Names: Taxotere®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First dose date up to 113 weeks plus 30 days
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.	First dose date up to 113 weeks plus 30 days
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.	Up to 90 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 117 Weeks
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.	Up to 117 Weeks
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.	Up to 117 Weeks
Serum Concentration of Magrolimab		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
Percentage of Participants Who Developed Anti-Magrolimab Antibodies		Up to 113 Weeks

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

General 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.

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Magrolimab
• Other Study ID Numbers: GS-US-548-5918; 2020-005265-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No