Study of Magrolimab in Patients With Solid Tumors

Solid Tumor Clinical Trial

— ELEVATELung&UC  

Official title:

A Phase 2, Multi-Arm Study of Magrolimab in Patients With Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04827576
• Other study ID #: GS-US-548-5918
• Secondary ID: 2020-005265-14
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 1, 2021
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: March 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• Magrolimab
Administered intravenously
• Docetaxel
Administered intravenously, 75 mg/m^2 on Day 1 of each cycle

Locations

Country	Name	City	State
France	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-benite
France	Institut de Cancérologie de l'Ouest (ICO) - Saint-Herblain	Saint Herblain
Poland	Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy	Bydgoszcz
Poland	Instytut Centrum Zdrowia Matki Polki	Lodz
Poland	Wojewodzki Szpital Specjalistyczny w Siedlcach	Siedlce
Spain	Hospital De La Santa Creu I Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Quironsalud Barcelona	Barcelona
Spain	Instituto de Investigacion Oncologica Vall de Hebron	Barcelona
Spain	Hospital Universitario de Jaen	Jaen
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital HM Sanchinarro	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	MD Anderson Cancer Center	Madrid
Spain	Hospital Regional Universitario de Malaga	Malaga
Spain	Clinica Universidad de Navarra	Pamplona
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	Valencia
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United States	University of Michigan	Ann Arbor	Michigan
United States	University Center and Blood Center,LLC.	Athens	Georgia
United States	Saint Alphonsus Cancer Institute Caldwell	Caldwell	Idaho
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	University of Miami	Deerfield Beach	Florida
United States	Astera Cancer Care	East Brunswick	New Jersey
United States	Cancer Treatment Centers of America	Goodyear	Arizona
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	Comprehensive Cancer Centers of Nevada- Twain Office	Las Vegas	Nevada
United States	Southeastern regional Medical Center	Newnan	Georgia
United States	Oregon Health & Science University	Portland	Oregon
United States	Virginia Piper Cancer Center (Alliant Health)	Saint Paul	Minnesota
United States	Huntsman Cancer Institute, University of Utah	Salt Lake City	Utah
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	Orchard Healthcare Research Inc	Skokie	Illinois
United States	Medical Oncology Associates,PS (dba Summit Cancer Center) (includes IP Shipment)	Spokane	Washington
United States	Tallahassee Memorial Healthcare Cancer Center	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  France,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE Version 5.0		First dose date up to 3 years
Primary	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	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
Secondary	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
Secondary	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
Secondary	Serum Concentration for Magrolimab		Up to end of treatment (approximately 3 years)
Secondary	Percentage of Participants who Developed Anti-Magrolimab Antibodies		Up to end of treatment (approximately 3 years)

External Links

•   Gilead Clinical Trials Website