What side effects are associated with this type of intervention?

Common treatments for breast cancer, including monoclonal antibodies and chemotherapeutic agents, often have a range of side effects. Monoclonal antibodies like trastuzumab and pertuzumab can cause infusion reactions, cardiotoxicity, and fatigue. Chemotherapeutic agents such as paclitaxel and nab-paclitaxel, which are used in combination with monoclonal antibodies, can lead to neuropathy, myelosuppression, alopecia, and gastrointestinal symptoms like nausea and vomiting. Patients may also experience immunosuppression, increasing the risk of infections. It is important to monitor and manage these side effects in collaboration with healthcare providers.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies for the treatment of breast cancer, including trastuzumab (Herceptin), pertuzumab (Perjeta), and ado-trastuzumab emtansine (Kadcyla), which target the HER2 receptor. Additionally, immune checkpoint inhibitors like pembrolizumab (Keytruda) have been approved for certain types of breast cancer, particularly triple-negative breast cancer. These treatments, while not identical to Magrolimab, share a similar approach in utilizing the immune system to target and destroy cancer cells.

What other types of research exist?

Promising novel alternatives to Magrolimab for breast cancer patients in 2024 include: 1) Sacituzumab Govitecan-hziy, an antibody-drug conjugate targeting Trop-2, which has shown efficacy in metastatic triple-negative breast cancer. 2) Immune checkpoint inhibitors such as Pembrolizumab (anti-PD-1) and Atezolizumab (anti-PD-L1), which have been effective in certain subtypes of breast cancer. 3) PARP inhibitors like Olaparib and Talazoparib, particularly for patients with BRCA mutations. 4) CDK4/6 inhibitors such as Palbociclib, Ribociclib, and Abemaciclib, which are used in combination with hormone therapy for HR-positive, HER2-negative breast cancer.

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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)

Be older than 18 years old

Must not have

Prior treatment with CD47 or signal regulatory protein alpha-targeting agents

Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 35 months

Awards & highlights

Summary

This trial is testing magrolimab combined with other cancer drugs in patients with advanced triple-negative breast cancer. The goal is to see if this combination helps the immune system fight the cancer and improves treatment outcomes.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been treated with drugs targeting CD47 or signal regulatory protein alpha.

Select...

I still have moderate to severe side effects from a previous treatment.

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I have a known bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 35 months

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

50%

Dry skin

40%

Pyrexia

40%

Headache

35%

Diarrhoea

35%

Fatigue

35%

Infusion related reaction

30%

Constipation

30%

Stomatitis

30%

Dermatitis acneiform

25%

Chills

25%

Decreased appetite

25%

Rash maculo-papular

25%

Hypomagnesaemia

25%

Blood bilirubin increased

20%

Anaemia

20%

Vomiting

20%

Hypokalaemia

20%

Depression

20%

Cough

15%

Dyspnoea

15%

Nausea

15%

Dehydration

15%

Lymphocyte count decreased

15%

Insomnia

10%

Arthralgia

10%

Oedema peripheral

10%

Rhinitis allergic

10%

Pruritus

10%

Rash

10%

Hypertension

10%

Abdominal pain

10%

Dizziness

10%

Tumour pain

10%

Haematuria

Small intestinal obstruction

Iron deficiency anaemia

Malignant neoplasm progression

Lung infection

Tooth abscess

Vaginal infection

White blood cell count decreased

Dysgeusia

Interstitial lung disease

Flushing

Raynaud's phenomenon

Respiratory failure

Musculoskeletal chest pain

Pollakiuria

Pulmonary congestion

Restless legs syndrome

Syncope

Tremor

Strabismus

Blepharal pigmentation

Abdominal distension

Enterocolitis

Gastrooesophageal reflux disease

Glossodynia

Chest discomfort

Influenza like illness

Non-cardiac chest pain

Blood sodium decreased

Weight decreased

Hypophosphataemia

Laryngeal haemorrhage

Pulmonary haemorrhage

Urinary hesitation

Immune thrombocytopenic purpura

Haemoptysis

Loose tooth

Early satiety

Pharyngitis

Fall

Alanine aminotransferase increased

Urticaria

Hypotension

Jugular vein thrombosis

Lymph node pain

Oedema

Bronchitis

Conjunctivitis

Upper respiratory tract infection

Pelvic fracture

Dysaesthesia

Epistaxis

Acne

Aspartate aminotransferase increased

Blood alkaline phosphatase increased

Platelet count decreased

Back pain

Flank pain

Musculoskeletal pain

Myalgia

Cerebral infarction

Restlessness

100%

80%

60%

40%

20%

Study treatment Arm

Magrolimab 45 mg/kg

Magrolimab Priming Dose Only

Magrolimab 10 mg/kg

Magrolimab 20 mg/kg

Magrolimab 30 mg/kg

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

Sacituzumab Govitecan-hziy

2019

Completed Phase 3

~550

Magrolimab

2021

Completed Phase 2

~210

Nab-Paclitaxel

2014

Completed Phase 3

~4540

Paclitaxel

2011

Completed Phase 4

~5380

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments work through various mechanisms to target and destroy cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Hormone therapy blocks hormones like estrogen that can promote the growth of hormone receptor-positive breast cancer. Targeted therapies, such as HER2 inhibitors, specifically target proteins that are overexpressed in some breast cancers, thereby inhibiting cancer cell growth and survival. Magrolimab, an anti-CD47 monoclonal antibody, promotes the phagocytosis of cancer cells by blocking the 'don't eat me' signal that cancer cells use to evade the immune system. These treatments are crucial as they offer multiple avenues to attack cancer cells, improving the chances of successful treatment and reducing the likelihood of resistance.

Recent updates on Sintilimab in solid tumor immunotherapy.