Study of Magrolimab in Patients With Solid Tumors

NCT04827576 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: GS-US-548-59182020-005265-14
• Study Type: interventional
• Target: 106
• Locations: 5 countries
• Sites: 49

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

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

  Up to 117 Weeks

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

  Up to 117 Weeks

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

  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

Study Arms (4)

Safety Run-in Cohort 1 (Magrolimab + Docetaxel)

EXPERIMENTAL

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; Drug: Docetaxel

Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)

EXPERIMENTAL

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; Drug: Docetaxel

Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)

EXPERIMENTAL

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; Drug: Docetaxel

Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)

EXPERIMENTAL

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; Drug: Docetaxel

Interventions

Magrolimab DRUG

Administered intravenously

Also known as: GS-4721

Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel); Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel); Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel); Safety Run-in Cohort 1 (Magrolimab + Docetaxel)

Docetaxel DRUG

Administered intravenously

Also known as: Taxotere®

Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel); Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel); Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel); Safety Run-in Cohort 1 (Magrolimab + Docetaxel)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (49)

Cancer Treatment Centers of America

Goodyear, Arizona, 85338, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare

Santa Rosa, California, 95403, United States

Location

University of Miami

Deerfield Beach, Florida, 33064, United States

Location

Tallahassee Memorial Healthcare Cancer Center

Tallahassee, Florida, 32308, United States

Location

University Center and Blood Center,LLC.

Athens, Georgia, 30607, United States

Location

Southeastern regional Medical Center

Newnan, Georgia, 30265, United States

Location

Saint Alphonsus Cancer Institute Caldwell

Caldwell, Idaho, 83605, United States

Location

Orchard Healthcare Research Inc

Skokie, Illinois, 60077, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Virginia Piper Cancer Center (Alliant Health)

Saint Paul, Minnesota, 55102, United States

Location

Comprehensive Cancer Centers of Nevada- Twain Office

Las Vegas, Nevada, 89169, United States

Location

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Charleston Oncology

Charleston, South Carolina, 29414, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

MD Anderson Cancer Center

Dallas, Texas, 77030, United States

Location

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

Location

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

Spokane, Washington, 99208, United States

Location

Institut Bergonie

Bordeaux, 33000, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Centre Hospitalier Regional Universitaire de Lille

Lille, 59037, France

Location

Centre LÃon BÃrard Centre RÃgional de Lutte Contre Le Cancer

Lyon, 69373, France

Location

Hopital Nord AP-HM

Marseille, 13005, France

Location

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

Nice, 6189, France

Location

Hôpital de la Pitié Salpétrière

Paris, 75013, France

Location

Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69310, France

Location

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

Saint-Herblain, France

Location

Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

Bydgoszcz, 85-796, Poland

Location

Instytut Centrum Zdrowia Matki Polki

Lodz, 93-513, Poland

Location

Wojewodzki Szpital Specjalistyczny w Siedlcach

Siedlce, 08-110, Poland

Location

Instituto de Investigacion Oncologica Vall de Hebron

Barcelona, 08035, Spain

Location

Hospital del Mar

Barcelona, 8003, Spain

Location

Hospital Quironsalud Barcelona

Barcelona, 8023, Spain

Location

Hospital De La Santa Creu I Sant Pau

Barcelona, 8041, Spain

Location

Hospital Universitario de Jaen

Jaén, 23007, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

MD Anderson Cancer Center

Madrid, 28033, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital HM Sanchinarro

Madrid, 28050, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Related Publications (6)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

magrolimab; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 8, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (14); GB (2); PL (3); US (21); FR (9)