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Monoclonal Antibodies

Magrolimab Combo for Triple-Negative Breast Cancer (ELEVATE TNBC Trial)

Phase 2
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cohort 1: Individuals with previously untreated 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 TNBC who have received at least 1 and no more than 2 prior lines of 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35 months
Awards & highlights

ELEVATE TNBC Trial Summary

This trial is testing the safety and effectiveness of two different combinations of drugs for people with triple-negative breast cancer that has spread.

Who is the study for?
This trial is for adults with advanced or metastatic triple-negative breast cancer that can't be removed by surgery. Cohort 1 includes those who haven't been treated and are PD-L1 negative, while Cohort 2 includes those who've had up to two prior treatments and must have used a taxane. Participants need good performance status and organ function, measurable disease, no recent serious CNS issues or certain blood disorders.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of magrolimab combined with chemotherapy (nab-paclitaxel/paclitaxel for untreated patients; sacituzumab govitecan-hziy for previously treated patients). It aims to determine the best doses and observe how well participants respond to these combinations in treating their breast cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as fatigue, infusion-related symptoms, possible low blood counts leading to increased infection risk or bleeding tendencies. Organ-specific inflammation might occur due to immune activation.

ELEVATE TNBC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have untreated advanced TNBC that is PD-L1 negative.
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I have TNBC, treated with a taxane and up to 2 therapies, including an immune checkpoint inhibitor if PD-L1 positive.
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My overall health is good, and my blood, kidney, and liver are functioning well.

ELEVATE TNBC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 35 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Phase 2 Cohort 1: PFS as Determined by Investigator Assessment Using RECIST Version 1.1
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
Secondary outcome measures
Antidrug Antibodies (ADA) to Magrolimab
Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2): PFS as Determined by Investigator Assessment Using RECIST Version 1.1
Magrolimab Concentration Versus Time
+4 more

Side effects data

From 2020 Phase 1 & 2 trial • 78 Patients • NCT02953782
67%
Dry skin
44%
Diarrhoea
44%
Dermatitis acneiform
44%
Fatigue
44%
Lymphocyte count decreased
33%
Infusion related reaction
33%
Abdominal pain
22%
Decreased appetite
22%
Small intestinal obstruction
22%
Tinnitus
22%
Nausea
22%
Chills
22%
Oedema peripheral
22%
Back pain
22%
Myalgia
22%
Headache
22%
Pruritus
22%
Dehydration
22%
Rash maculo-papular
11%
Hypertension
11%
Dyspnoea
11%
Lymphopenia
11%
Malignant neoplasm progression
11%
Cerebrovascular accident
11%
Anaemia
11%
Palpitations
11%
Conjunctivitis allergic
11%
Dry eye
11%
Abdominal distension
11%
Constipation
11%
Dyspepsia
11%
Gastrooesophageal reflux disease
11%
Hypoaesthesia oral
11%
Folliculitis
11%
Sinusitis
11%
Gastrointestinal stoma complication
11%
Aspartate aminotransferase increased
11%
Blood bilirubin increased
11%
Hypokalaemia
11%
Hypomagnesaemia
11%
Hypophosphataemia
11%
Tumour pain
11%
Dizziness
11%
Confusional state
11%
Depression
11%
Haematuria
11%
Dysphonia
11%
Ingrowing nail
11%
Skin infection
11%
Tinea cruris
11%
Platelet count decreased
11%
Alanine aminotransferase increased
11%
Photopsia
11%
Conjunctivitis
11%
Gastroenteritis viral
11%
Hyperglycaemia
11%
Arthralgia
11%
Neck pain
11%
Somnolence
11%
Nasal congestion
11%
Deep vein thrombosis
11%
Oesophageal pain
11%
Vomiting
11%
Chest discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Magrolimab 10 mg/kg
Magrolimab 20 mg/kg
Magrolimab 30 mg/kg
Magrolimab 45 mg/kg
Magrolimab Priming Dose Only

ELEVATE TNBC Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Safety Run-in Cohort 2: Magrolimab + Sacituzumab govitecanExperimental Treatment2 Interventions
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.
Group II: Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel or PaclitaxelExperimental Treatment3 Interventions
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.
Group III: Phase 2 Cohort 2: Magrolimab + Sacituzumab govitecanExperimental Treatment2 Interventions
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.
Group IV: Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or PaclitaxelExperimental Treatment3 Interventions
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.
Group V: Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or PaclitaxelActive Control3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magrolimab
2018
Completed Phase 2
~120
Nab-Paclitaxel
2014
Completed Phase 3
~4340
Paclitaxel
2011
Completed Phase 4
~5380
Sacituzumab Govitecan-hziy
2019
Completed Phase 3
~550

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,077 Previous Clinical Trials
836,858 Total Patients Enrolled
17 Trials studying Breast Cancer
6,872 Patients Enrolled for Breast Cancer
Gilead Study DirectorStudy DirectorGilead Sciences
341 Previous Clinical Trials
185,738 Total Patients Enrolled
2 Trials studying Breast Cancer
765 Patients Enrolled for Breast Cancer

Media Library

Magrolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04958785 — Phase 2
Breast Cancer Research Study Groups: Safety Run-in Cohort 2: Magrolimab + Sacituzumab govitecan, Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel, Phase 2 Cohort 2: Magrolimab + Sacituzumab govitecan, Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel or Paclitaxel, Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel
Breast Cancer Clinical Trial 2023: Magrolimab Highlights & Side Effects. Trial Name: NCT04958785 — Phase 2
Magrolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04958785 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main diseases or conditions that Magrolimab is used as a treatment for?

"Magrolimab is most often used clinically to treat neoplasm metastasis, but it also has potential efficacy in treating kaposi sarcoma, advanced directives, and fallopian tubes cancer."

Answered by AI

In how many medical facilities is this clinical trial being conducted?

"Presently, there are 14 enrolment centres for this trial. They are situated in Salt Lake City, Atlanta and Fresno as well as 11 other places. If you are thinking about participating in this study, it would be most convenient for you to choose a location near to you to cut down on travel time."

Answered by AI

What kind of side effects has Magrolimab been known to cause in patients?

"Magrolimab's safety was given a score of 2 by our team at Power. This is because, while there is data supporting its safety, there is none yet proving its efficacy in Phase 2 of the trial."

Answered by AI

Is this the first time Magrolimab has been studied?

"There are 888 live studies currently underway for Magrolimab. 237 of those are in Phase 3, the final stage before seeking FDA approval. Most of these trials taking place in Woolloongabba, Queensland, but there are 46612 total locations running these sorts of tests."

Answered by AI

How many participants are being enrolled in this trial?

"Yes, the trial is recruiting patients at 14 sites across the United States of America. According to the study's information page on clinicaltrials.gov, it was originally posted on December 14th, 2021 and updated November 8th, 2022. The goal is to have 144 total participants."

Answered by AI

Are people currently being accepted into this clinical trial?

"Yes. The clinical trial is recruiting patients at 14 sites across the United States of America. The study was posted on December 14th, 2021 and updated November 8th, 2022. They are currently looking for 144 individuals to participate."

Answered by AI
~12 spots leftby Aug 2024