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 patients with solid tumors.

Study Overview

• Status: Active, not recruiting
• 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 Contact: Name: Gilead Clinical Study Information Center; Phone Number: 1-833-445-3230 (GILEAD-0); Email: GileadClinicalTrials@gilead.com

Study Locations

• France
  • Bordeaux, France, 33000
    • Institut Bergonié
  • 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 Cancérologie 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 Jaén
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center
  • Madrid, Spain, 28050
    • Hospital HM Sanchinarro
  • Malaga, Spain, 29010
    • Hospital Regional Universitario de Malaga
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío
  • 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 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, mNSCLC, mUC, mSCLC (Magrolimab + Docetaxel); Participants with solid tumors (metastatic non-small cell lung cancer (mNSCLC), metastatic urothelial cancer (mUC), metastatic small cell lung cancer (mSCLC)) will receive an escalating dose of magrolimab and docetaxel.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Docetaxel; Administered intravenously, 75 mg/m^2 on Day 1 of each cycle; Other Names: Taxotere®
Experimental: Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel); Participants with mNSCLC will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety Run-in Cohort 1 and docetaxel.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Docetaxel; Administered intravenously, 75 mg/m^2 on Day 1 of each cycle; Other Names: Taxotere®
Experimental: Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel); Participants with mUC will receive magrolimab at the RP2D determined in the Safety Run-in Cohort 1 and docetaxel.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Docetaxel; Administered intravenously, 75 mg/m^2 on Day 1 of each cycle; Other Names: Taxotere®
Experimental: Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel); Participants with mSCLC will receive magrolimab at the RP2D determined in the Safety Run-in Cohort 1 and docetaxel.	Drug: Magrolimab; Administered intravenously; Other Names: GS-4721; Drug: Docetaxel; Administered intravenously, 75 mg/m^2 on Day 1 of each cycle; Other Names: Taxotere®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Experiencing Adverse Events According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0		First dose date up to 3 years
Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE Version 5.0		First dose date up to 3 years
Objective response rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c)	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR), as measured by RECIST version 1.1, as determined by investigator assessment.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c)	PFS is defined as the time from the date of dose initiation until the earliest date of documented disease progression, as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurs first.	Up to 3 years
Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c)	DOR is defined as time from first documentation of CR or PR to the earliest date of documented disease progression, per RECIST version 1.1, or death from any cause, whichever occurs first, as determined by investigator assessment.	Up to 3 years
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.	Up to 3 years
Serum Concentration for Magrolimab		Up to end of treatment (approximately 3 years)
Percentage of Participants who Developed Anti-Magrolimab Antibodies		Up to end of treatment (approximately 3 years)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): March 1, 2025

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): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; 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