Drug

Margetuximab

Approved medicine

ClassReceptor protein-tyrosine kinase erbB-2 inhibitorResearchOngoing clinical research

Also known as Margenza.

RxNorm2473851 ChEMBLCHEMBL2364649 ATCL01FD06UNIIK911R84KEW

Research papers

Active clinical trials

ERBB2

Primary target

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

MARGetuximab Or Trastuzumab (MARGOT): A Phase II Study Comparing Neoadjuvant Paclitaxel/Margetuximab/Pertuzumab to Paclitaxel/Trastuzumab/Pertuzumab in Patients With Stage II-III HER2-positive Breast Cancer

Clinical trial2025-11-18Results posted · ClinicalTrials.gov

A Phase 2/3 Trial to Evaluate Margetuximab in Combination With INCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in Patients With Metastatic or Locally Advanced, Treatment-naïve, HER2-Positive Gastric or Gastroesophageal Junction Cancer

Clinical trial2025-06-08Results posted · ClinicalTrials.gov

A Phase 1b/2, Open Label, Dose Escalation Study of Margetuximab in Combination With Pembrolizumab in Patients With Relapsed/Refractory Advanced HER2+ Gastroesophageal Junction or Gastric Cancer

Clinical trial2025-03-17Results posted · ClinicalTrials.gov

A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment

Clinical trial2025-03-17Results posted · ClinicalTrials.gov

A Single Arm, Open-Label, Phase 2 Study of MGAH22 (Fc-optimized Chimeric Anti-HER2 Monoclonal Antibody) in Patients With Relapsed or Refractory Advanced Breast Cancer Whose Tumors Express HER2 at the 2+ Level by Immunohistochemistry and Lack Evidence of HER2 Gene Amplification by FISH

Clinical trial2025-03-13Results posted · ClinicalTrials.gov

A Phase II Trial of Margetuximab in Combination With Tucatinib and Capecitabine in Patients With HER2-Positive Metastatic Breast Cancer

Clinical trial2024-10-01Withdrawn · ClinicalTrials.gov

A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein Binding PD-1 and LAG-3 in Patients With Unresectable or Metastatic Neoplasms

Clinical trial2023-02-08Completed · ClinicalTrials.gov

A Phase 1, Dose Escalation Study of MGAH22 in Patients With Refractory HER2 Positive Breast Cancer and Patients With Other HER2 Positive Carcinomas for Whom No Standard Therapy Is Available

Clinical trial2022-06-14Completed · ClinicalTrials.gov

A Randomized, Open-Label, Multiple-center, Phase II Study to Evaluate the Efficacy and Safety of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies

Clinical trial2021-09-03Primary completion · ClinicalTrials.gov

Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial.

Research2021-04-01JAMA oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Margetuximab

Aliases & brands

Margenza

RxNorm CUI

2473851

ChEMBL ID

CHEMBL2364649

ATC codes

L01FD06

UNII

K911R84KEW

Primary mechanism

Receptor protein-tyrosine kinase erbB-2 inhibitor

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Receptor tyrosine-protein kinase erbB-2

ERBB2 · P04626

INHIBITORReceptor protein-tyrosine kinase erbB-2 inhibitor

Clinical trials

9 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2025

Active studies

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 9

Phase 12Phase 1 / 21Phase 24Phase 2 / 31Phase 31

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

CompletedPH II/IIIMacroGenicsn=822025

CompletedPH IIIMacroGenicsn=6242022

Recent completions

Trials that read out recently, adding to the completed evidence base.

CompletedPH II/IIIMacroGenicsn=822025

A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein Binding PD-1 and LAG-3 in Patients With Unresectable or Metastatic Neoplasms

CompletedPH IMacroGenicsn=2772023

CompletedPH IIIMacroGenicsn=6242022

A Phase 1, Dose Escalation Study of MGAH22 in Patients With Refractory HER2 Positive Breast Cancer and Patients With Other HER2 Positive Carcinomas for Whom No Standard Therapy Is Available

CompletedPH IMacroGenicsn=662022

A Phase 1b/2, Open Label, Dose Escalation Study of Margetuximab in Combination With Pembrolizumab in Patients With Relapsed/Refractory Advanced HER2+ Gastroesophageal Junction or Gastric Cancer

CompletedPH I/IIMacroGenicsn=952021

CompletedPH IIMacroGenicsn=252017

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial.

JAMA oncology · 2021 · 263 cites

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Ado-trastuzumab emtansine

Studied across the same disease area as Margetuximab in the shared literature.

1 shared disease1 shared paper

Trastuzumab

Studied across the same disease area as Margetuximab in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials