margetuximab
margetuximab: developed by 1 company · 6 clinical trials tracked · 1 FDA decision.
margetuximab evidence translation
What we can confirm
1 FDA record · 6 tracked trials
What it means
What to watch
Prepared research question
How could margetuximab → MGNX affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence5 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (1)
| Company | Phase |
|---|---|
| MACROGENICS INC (MGNX) In combination with chemotherapy for treatment of adult pati… | Approved |
Clinical Trials (6)
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
Primary endpoint: Pathologic Complete Response (pCR)
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
Primary endpoint: Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0
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
Primary endpoint: Number of Patients With Dose Limiting Toxicities
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
Primary endpoint: Progression-free Survival (PFS) as Determined by Independent Radiological Review.
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
Primary endpoint: Best Overall Response
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
Primary endpoint: Occurrence of Adverse Events and Serious Adverse Events
FDA Decisions1 records
Frequently asked questions
Who is developing margetuximab?
margetuximab is being developed by MACROGENICS INC.
How many clinical trials involve margetuximab?
BioSniper tracks 6 clinical trials involving margetuximab.
What is margetuximab's latest FDA decision?
The most recent tracked FDA decision for margetuximab is Approval for 1 INDICATIONS AND USAGE MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1) ]. MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cance, dated December 16, 2020.