margetuximab
Trade name: Margenza
mAbapprovedFast Track FDA
Approved
Dec 16, 2020
Margetuximab, sold under the brand name Margenza, is a chimeric IgG monoclonal antibody medication against HER2 used for the treatment of cancer. — Wikipedia
Clinical trial activity
11 trials · 12 clinical orgs · 1 marketing orgs
Phase 1
4
Phase 2
6
Phase 3
2
Phase 4
0
Earliest trial started Jul 1, 2010 (NCT01148849)
Timeline
2010s
- Jan 1, 2010
MacroGenics — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2013
MacroGenics — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2015
MacroGenics — Earliest Phase 3 Sponsor(trial)
2020s
- Dec 16, 2020
MacroGenics — Earliest FDA Approval
- Dec 16, 2020
MacroGenics — Marketing Organization
- Dec 16, 2020
MacroGenics — NDA Secondary Org
- Dec 16, 2020
MacroGenics — NDA Organization
Indications
Approved for
Studied for
- Breast Neoplasms · Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 1
- Cholangiocarcinoma · Phase 1
- Esophageal Neoplasms · Phase 2/Phase 3
- Hematologic Neoplasms · Phase 1
- Neoplasm Metastasis · Phase 3
- Neoplasms · Phase 1
- Ovarian Neoplasms · Phase 1
- Small Cell Lung Carcinoma · Phase 1
- Squamous Cell Carcinoma of Head and Neck · Phase 1
- Stomach Neoplasms · Phase 2/Phase 3
- Uterine Cervical Neoplasms · Phase 1
Mechanism of action
ERBB2 inhibitor
Antibody-dependent cell-mediated cytotoxicity (ADCC).
Approval history
- approvedFast trackDec 16, 2020
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaMargetuximab ↗
- ChEMBLCHEMBL2364649 ↗
Also known as
- margetuximab
- margetuximab
- mgah22
- mgah22
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05227131 | Phase 2 | May 15, 2022 | MacroGenics, MedSIR, Seattle Genetics |
| NCT04425018 | Phase 2 | Jun 30, 2020 | Harvard University, MacroGenics, Translational Breast Cancer Research Consortium |
| NCT04398108 | Phase 1 | Jun 30, 2020 | Henan Medical University, People's Liberation Army of China, Zai Lab Pty. Ltd. |
| NCT04262804 | Phase 2 | Jan 13, 2020 | Zai Lab Pty. Ltd. |
| NCT04082364 | Phase 2/Phase 3 (Phase 3) | Sep 30, 2019 | MacroGenics, Zai Lab Pty. Ltd. |
| NCT03219268 | Phase 1 | Aug 18, 2017 | MacroGenics |
| NCT02689284 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2016 | MacroGenics, Merck |
| NCT02492711 | Phase 3 | Jul 1, 2015 | MacroGenics |
| NCT01828021 | Phase 2 | Mar 1, 2013 | MacroGenics, Stanford University |
| NCT01148849 | Phase 1 | Jul 1, 2010 | Green Cross Corporation, MacroGenics, National Cancer Institute (NCI) |
| NCT03133988 | N/A | — | MacroGenics |
Showing 11 of 11 trials
Page 1 / 1
Organizations
Research & Development (12)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| MacroGenics | For profit | 9 | 7 | 4 | 2010 |
| Zai Lab Pty. Ltd. | For profit | 3 | 2 | 3 | 2019 |
| Green Cross Corporation | For profit | 1 | 0 | 1 | 2010 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Henan Medical University | Academic/Hospital | 1 | 0 | 1 | 2020 |
| MedSIR | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Merck | For profit | 1 | 0 | 1 | 2016 |
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 2010 |
| People's Liberation Army of China | Government | 1 | 0 | 1 | 2020 |
| Seattle Genetics | For profit | 1 | 0 | 1 | 2022 |
| Stanford University | Academic/Hospital | 1 | 0 | 1 | 2013 |
| Translational Breast Cancer Research Consortium | Academic/Hospital | 1 | 0 | 1 | 2020 |
12 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| MacroGenics | For profit | MKTG | Dec 16, 2020 |
| MacroGenics | For profit | NDA2 | Dec 16, 2020 |
| MacroGenics | For profit | NDA | Dec 16, 2020 |