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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04958785




Registration number
NCT04958785
Ethics application status
Date submitted
1/07/2021
Date registered
12/07/2021

Titles & IDs
Public title
Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer
Scientific title
A Phase 2 Study of Magrolimab Combination Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer
Secondary ID [1] 0 0
2021-001074-27
Secondary ID [2] 0 0
GS-US-586-6144
Universal Trial Number (UTN)
Trial acronym
ELEVATE TNBC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triple-Negative Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Magrolimab
Treatment: Drugs - Nab-Paclitaxel
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Sacituzumab Govitecan-hziy

Experimental: Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel or Paclitaxel - Participants with untreated unresectable, locally advanced or metastatic TNBC whose tumors are not appropriate for immune checkpoint inhibitor therapy will receive the following:

* magrolimab in de-escalating doses to establish RP2D
* nab-paclitaxel or paclitaxel administered according to local guidelines.

Each cycle is 28 days.

Experimental: Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel - Participants with mTNBC will receive the RP2D determined in the Safety Run-in cohort of magrolimab in combination with nab-paclitaxel or paclitaxel administered according to local guidelines.

Each cycle is 28 days.

Magrolimab will be continued until development of unacceptable toxicity that cannot be clinically managed by dose or schedule modifications. Nab-paclitaxel or paclitaxel will be continued until development of unacceptable toxicity.

Active comparator: Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel - Participants with mTNBC will receive nab-paclitaxel or paclitaxel administered according to local guidelines.

Each cycle is 28 days.

Nab-paclitaxel or paclitaxel will be continued until development of unacceptable toxicity.

Experimental: Safety Run-in Cohort 2: Magrolimab + Sacituzumab govitecan - Participants with unresectable, locally advanced or metastatic TNBC who have received at least 1 and no more than 2 prior lines of treatment in the unresectable, locally advanced or metastatic setting will receive the following:

* magrolimab in de-escalating doses to establish RP2D
* sacituzumab govitecan on Days 1 and 8

Each cycle is 21 days.

Experimental: Phase 2 Cohort 2: Magrolimab + Sacituzumab govitecan - Participants with mTNBC will receive the RP2D determined in the Safety Run-in cohort of magrolimab in combination with sacituzumab govitecan on Days 1 and 8. Each cycle is 21 days.

Magrolimab will be continued until development of unacceptable toxicity that cannot be clinically managed by dose or schedule modifications.sacituzumab govitecan will be continued until development of unacceptable toxicity.


Treatment: Drugs: Magrolimab
Administered intravenously

Treatment: Drugs: Nab-Paclitaxel
Administered intravenously

Treatment: Drugs: Paclitaxel
Administered intravenously

Treatment: Drugs: Sacituzumab Govitecan-hziy
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Run-in Cohorts: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs), Adverse Events (AEs), and Laboratory Abnormalities According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0
Timepoint [1] 0 0
First dose date up to 35 months
Primary outcome [2] 0 0
Phase 2 Cohort 1: PFS as Determined by Investigator Assessment Using RECIST Version 1.1
Timepoint [2] 0 0
Up to 35 months
Primary outcome [3] 0 0
Cohort 2 (Safety Run-In Cohort 2 and Phase 2 Cohort 2): Confirmed Objective Response Rate (ORR) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Timepoint [3] 0 0
Up to 35 months
Secondary outcome [1] 0 0
Phase 2 Cohort 1: Confirmed Objective Response Rate (ORR) as Determined by Investigator Assessment
Timepoint [1] 0 0
Up to 35 months
Secondary outcome [2] 0 0
Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2): PFS as Determined by Investigator Assessment Using RECIST Version 1.1
Timepoint [2] 0 0
Up to 35 months
Secondary outcome [3] 0 0
Phase 2 Cohort 1 and Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2): Duration of Response (DOR) as Determined by Investigator Assessment per RECIST Version 1.1
Timepoint [3] 0 0
Up to 35 months
Secondary outcome [4] 0 0
Phase 2 Cohort 1 and Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2): Overall Survival (OS)
Timepoint [4] 0 0
Up to 35 months
Secondary outcome [5] 0 0
Phase 2 Cohort 1 and Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2): Percentage of Participants Experiencing AEs and Laboratory Abnormalities According to NCI CTCAE, Version 5.0
Timepoint [5] 0 0
First dose date up to 35 months
Secondary outcome [6] 0 0
Magrolimab Concentration Versus Time
Timepoint [6] 0 0
Up to end of treatment (approximately 35 months)
Secondary outcome [7] 0 0
Antidrug Antibodies (ADA) to Magrolimab
Timepoint [7] 0 0
Up to end of treatment (approximately 35 months)

Eligibility
Key inclusion criteria
Key Inclusion criteria:

* Adequate performance status, hematologic, renal and liver function.
* Measurable disease per RECIST v1.1
* Cohort 1: Individuals with previously untreated with systemic therapy for unresectable locally advanced or metastatic TNBC that are considered PD-L1 negative (as determined by an approved test according to local regulations).
* Cohort 2: Individuals with unresectable, locally advanced or metastatic breast cancer with a diagnosis of TNBC who have received at least 1 and no more than 2 prior lines of systemic therapy in the unresectable, locally advanced or metastatic setting. Individuals must have been previously treated with a taxane in any setting. Individuals with tumors that are considered positive for PD-L1 expression (as determined by an approved test according to local regulations) must have received an immune checkpoint inhibitor for a prior-line of treatment for unresectable locally advanced/metastatic TNBC.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Positive serum pregnancy test or breastfeeding female.
* Active CNS disease. Individuals with asymptomatic and stable, treated CNS lesions (who have been off steroids, radiation and/or surgery and/or other CNS-directed therapy for at least 4 weeks) are allowed.
* RBC transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening. Red blood cell 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.
* Prior treatment with CD47 or signal regulatory protein alpha-targeting agents.
* Known inherited or acquired bleeding disorders.
* Cohort 1 only: Disease progression within 6 months following neoadjuvant/adjuvant therapy.
* Cohort 2 only:

* Individuals with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and Individuals with a history of bowel obstruction or gastrointestinal perforation within 6 months of enrollment.
* Individuals who previously received topoisomerase I inhibitors or antibody-drug conjugates containing a topoisomerase inhibitor.
* High-dose systemic corticosteroids (= 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Cycle 1 Day 1.
* Have not recovered (ie, = Grade 2 is considered not recovered) from AEs due to a previously administered agent.

* Note: individuals with any grade of neuropathy, alopecia, hypo- or hyperthyroidism, or other endocrinopathies that are well controlled with hormone replacement are an exception to this criterion and will qualify for the study.
* Note: if individuals received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Cairns and Hinterland Hospital and Health Service - Cairns
Recruitment hospital [2] 0 0
University of the Sunshine Coast - Sippy Downs
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [8] 0 0
Peninsula Health - Frankston
Recruitment hospital [9] 0 0
Barwon Health- University Hospital Geelong - Geelong
Recruitment hospital [10] 0 0
Ballarat Oncology & Haematology Services - Wendouree
Recruitment postcode(s) [1] 0 0
4870 - Cairns
Recruitment postcode(s) [2] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3199 - Frankston
Recruitment postcode(s) [9] 0 0
'03220 - Geelong
Recruitment postcode(s) [10] 0 0
3355 - Wendouree
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
Hong Kong
State/province [12] 0 0
Hong Kong
Country [13] 0 0
Hong Kong
State/province [13] 0 0
Kowloon
Country [14] 0 0
Hong Kong
State/province [14] 0 0
New Territories
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Gangnam-Gu
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Goyang-si
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Jongrogu
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Taiwan
State/province [19] 0 0
Beitou District
Country [20] 0 0
Taiwan
State/province [20] 0 0
Changhua City
Country [21] 0 0
Taiwan
State/province [21] 0 0
Guishan District
Country [22] 0 0
Taiwan
State/province [22] 0 0
Sanmin District
Country [23] 0 0
Taiwan
State/province [23] 0 0
Tapiei
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Leicester
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04958785