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STATUS Recruitment Complete

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

LAST UPDATED

March 21, 2024

Clinicaltrials.gov ID

NCT04827576

EudraCT ID

2020-005265-14

OVERVIEW

A Phase 2, Multi-Arm Study of Magrolimab in Patients With Solid Tumors (ELEVATELung&UC)

PROTOCOL SUMMARY

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.

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

All

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Solid Tumor

Gender

N/A

Date

October 2021 - August 2024

Study Type

Interventional

Study Phase

Phase 2

Product

Magrolimab, Docetaxel

Eligibility Information

Inclusion

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.
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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.
  • 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.
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Locations

Locations (49)
Other

Cancer Treatment Centers of America

Goodyear, Arizona, United States, 85338

Other

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093

Other

Providence Saint John's Health Center

Santa Monica, California, United States, 90404

Other

St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare

Santa Rosa, California, United States, 95403

Other

University of Miami

Deerfield Beach, Florida, United States, 33064

Other

Tallahassee Memorial Healthcare Cancer Center

Tallahassee, Florida, United States, 32308

Other

University Center and Blood Center,LLC.

Athens, Georgia, United States, 30607

Other

Southeastern regional Medical Center

Newnan, Georgia, United States, 30265

Other

Saint Alphonsus Cancer Institute Caldwell

Caldwell, Idaho, United States, 83605

Other

Orchard Healthcare Research Inc

Skokie, Illinois, United States, 60077

Other

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States, 52242

Other

University of Michigan

Ann Arbor, Michigan, United States, 48109

Other

Virginia Piper Cancer Center (Alliant Health)

Saint Paul, Minnesota, United States, 55102

Other

Comprehensive Cancer Centers of Nevada- Twain Office

Las Vegas, Nevada, United States, 89169

Other

Astera Cancer Care

East Brunswick, New Jersey, United States, 08816

Other

Oregon Health & Science University

Portland, Oregon, United States, 97239

Other

Charleston Oncology

Charleston, South Carolina, United States, 29414

Other

Mary Crowley Cancer Research

Dallas, Texas, United States, 75230

Other

MD Anderson Cancer Center

Dallas, Texas, United States, 77030

Other

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States, 84112

Other

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

Spokane, Washington, United States, 99208

Other

Institut Bergonie

Bordeaux, France, 33000

Other

Centre Georges François Leclerc

Dijon, France, 21079

Other

Centre Hospitalier Regional Universitaire de Lille

Lille, France, 59037

Other

Centre LÃon BÃrard Centre RÃgional de Lutte Contre Le Cancer

Lyon, France, 69373

Other

Hopital Nord AP-HM

Marseille, France, 13005

Other

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

Nice, France, 6189

Other

Hôpital de la Pitié Salpétrière

Paris, France, 75013

Other

Centre Hospitalier Lyon-Sud

Pierre-benite, France, 69310

Other

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

Saint Herblain, France

Other

Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

Bydgoszcz, Poland, 85-796

Other

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland, 93-513

Other

Wojewodzki Szpital Specjalistyczny w Siedlcach

Siedlce, Poland, 08-110

Other

Instituto de Investigacion Oncologica Vall de Hebron

Barcelona, Spain, 08035

Other

Hospital del Mar

Barcelona, Spain, 8003

Other

Hospital Quironsalud Barcelona

Barcelona, Spain, 8023

Other

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain, 8041

Other

Hospital Universitario de Jaen

Jaen, Spain, 23007

Other

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28007

Other

MD Anderson Cancer Center

Madrid, Spain, 28033

Other

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Other

Hospital HM Sanchinarro

Madrid, Spain, 28050

Other

Hospital Regional Universitario de Malaga

Malaga, Spain, 29010

Other

Clinica Universidad de Navarra

Pamplona, Spain, 31008

Other

Hospital Universitario Virgen Macarena

Sevilla, Spain, 41009

Other

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 41013

Other

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Other

Barts Health NHS Trust

London, United Kingdom, EC1A 7BE

Other

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom, SE1 9RT