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Drug

Margetuximab

In clinical development
ClassReceptor protein-tyrosine kinase erbB-2 inhibitorEmerging researchLate-stage development

Also known as Margenza.

RxNorm2473851ChEMBLCHEMBL2364649ATCL01FD06UNIIK911R84KEW
1
Research papers
1
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
9
registered trials across all phases
LATEST COMPLETION 2025
1
Active studies
2
Late-stage (III+)
6
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 9
Phase 12Phase 1 / 21Phase 24Phase 2 / 31Phase 31

Recent completions

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

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

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

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

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

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

CompletedPH IIMacroGenicsn=252017

Research activity

1 papers

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

Major research themes3
Antibodies, Monoclonal1Breast Neoplasms1Trastuzumab1
Journals, researchers & institutions
Top journals
  • JAMA oncology1
Leading researchers
  • Bonvini E1
  • Brown-Glaberman U1
  • Cardoso F1
  • Cortés J1
  • Curigliano G1
  • de Boer M1
  • De Laurentiis M1
  • Edlich S1
Leading institutions
free-text, unnormalised
  • Asan Medical Center1
  • Centre Antoine Lacassagne1
  • Centre François Baclesse1
  • Chaim Sheba Medical Center1
  • Champalimaud Clinical Center/Champalimaud Foundation1
  • Davidoff Cancer Center1
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