Study of Magrolimab in Patients With Solid Tumors

NCT ID: NCT04827576

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-10-01

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Magrolimab

Intervention Type: DRUG

Administered intravenously

Docetaxel

Intervention Type: DRUG

Administered intravenously

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.

Group Type: EXPERIMENTAL

Magrolimab

Intervention Type: DRUG

Administered intravenously

Docetaxel

Intervention Type: DRUG

Administered intravenously

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.

Group Type: EXPERIMENTAL

Magrolimab

Intervention Type: DRUG

Administered intravenously

Docetaxel

Intervention Type: DRUG

Administered intravenously

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.

Group Type: EXPERIMENTAL

Magrolimab

Intervention Type: DRUG

Administered intravenously

Docetaxel

Intervention Type: DRUG

Administered intravenously

Interventions

Magrolimab

Administered intravenously

Intervention Type: DRUG

Docetaxel

Administered intravenously

Intervention Type: DRUG

Other Intervention Names

GS-4721; Taxotere®

Eligibility Criteria

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

• 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.

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Cancer Treatment Centers of America

Goodyear, Arizona, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Providence Saint John's Health Center

Santa Monica, California, United States

St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare

Santa Rosa, California, United States

University of Miami

Deerfield Beach, Florida, United States

Tallahassee Memorial Healthcare Cancer Center

Tallahassee, Florida, United States

University Center and Blood Center,LLC.

Athens, Georgia, United States

Southeastern regional Medical Center

Newnan, Georgia, United States

Saint Alphonsus Cancer Institute Caldwell

Caldwell, Idaho, United States

Orchard Healthcare Research Inc

Skokie, Illinois, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

University of Michigan

Ann Arbor, Michigan, United States

Virginia Piper Cancer Center (Alliant Health)

Saint Paul, Minnesota, United States

Comprehensive Cancer Centers of Nevada- Twain Office

Las Vegas, Nevada, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

Oregon Health & Science University

Portland, Oregon, United States

Charleston Oncology

Charleston, South Carolina, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

MD Anderson Cancer Center

Dallas, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

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

Spokane, Washington, United States

Institut Bergonie

Bordeaux, , France

Centre Georges François Leclerc

Dijon, , France

Centre Hospitalier Regional Universitaire de Lille

Lille, , France

Centre LÃon BÃrard Centre RÃgional de Lutte Contre Le Cancer

Lyon, , France

Hopital Nord AP-HM

Marseille, , France

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

Nice, , France

Hôpital de la Pitié Salpétrière

Paris, , France

Centre Hospitalier Lyon-Sud

Pierre-Bénite, , France

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

Saint-Herblain, , France

Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

Bydgoszcz, , Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, , Poland

Wojewodzki Szpital Specjalistyczny w Siedlcach

Siedlce, , Poland

Instituto de Investigacion Oncologica Vall de Hebron

Barcelona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Quironsalud Barcelona

Barcelona, , Spain

Hospital De La Santa Creu I Sant Pau

Barcelona, , Spain

Hospital Universitario de Jaen

Jaén, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

MD Anderson Cancer Center

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital HM Sanchinarro

Madrid, , Spain

Hospital Regional Universitario de Malaga

Málaga, , Spain

Clinica Universidad de Navarra

Pamplona, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Barts Health NHS Trust

London, , United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Countries

United States; France; Poland; Spain; United Kingdom

References

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.

Reference Type: 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.

Reference Type: 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.

Reference Type: 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.

Reference Type: 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.

Reference Type: 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.

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.gileadclinicaltrials.com/study/?id=GS-US-548-5918

Gilead Clinical Trials Website

Other Identifiers

2020-005265-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-548-5918

Identifier Type: -

Identifier Source: org_study_id