Trastuzumab deruxtecan

Generic Name
Trastuzumab deruxtecan
Brand Names
Enhertu
Drug Type
Biotech
Chemical Formula
-
CAS Number
1826843-81-5
Unique Ingredient Identifier
5384HK7574
Background

Trastuzumab deruxtecan is a HER-2 directed antibody attached to a topoisomerase inhibitor that is approved for use in certain types of metastatic, unresectable breast cancer. It is classified as an antibody-drug conjugate. The cleavable peptide linker used to bind the antibody and drug in this product distinguishes it from other members of its class. Trastuz...

Indication

In the US, trastuzumab deruxtecan is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. It...

Associated Conditions
Advanced Gastric Adenocarcinoma, Advanced Gastroesophageal Adenocarcinoma, Metastatic Breast Cancer, Metastatic Breast Cancer With HER2 Positive, Unresectable Breast Cancer, Locally advanced HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Locally advanced HER2-positive Gastric Adenocarcinoma, Metastatic HER2 Mutant Non-small Cell Lung Cancer, Metastatic HER2-low Breast Cancer, Metastatic HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Metastatic HER2-positive Gastric Adenocarcinoma, Unresectable HER2 Mutant Non-small Cell Lung Cancer, Unresectable HER2-low Breast Cancer, Unresectable HER2/Neu-positive Breast Cancer
Associated Therapies
-

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2018-04-23
Last Posted Date
2024-04-29
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
181
Registration Number
NCT03505710
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Washington University School of Medicine at St. Louis, Saint Louis, Missouri, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 18 locations

DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2017-12-28
Last Posted Date
2021-10-18
Lead Sponsor
Daiichi Sankyo Co., Ltd.
Target Recruit Count
86
Registration Number
NCT03384940
Locations
🇺🇸

UCLA Health, Santa Monica, California, United States

🇮🇹

Oncology Institute Veneto IOV-IRCCS, Padova, Ferrara, Italy

🇪🇸

Hospital Universitari Vall d'Hebron, Barcelona, Spain

and more 22 locations

Study of DS-8201a for Participants With Advanced Solid Malignant Tumors

First Posted Date
2017-12-26
Last Posted Date
2023-12-11
Lead Sponsor
Daiichi Sankyo Co., Ltd.
Target Recruit Count
40
Registration Number
NCT03383692
Locations
🇯🇵

Hokkaido Cancer Center, Sapporo, Hokkaido, Japan

🇯🇵

Hokkaido University Hospital, Sapporo, Hokkaido, Japan

🇯🇵

Kobe University Hospital, Kobe, Hyogo, Japan

and more 7 locations

DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein

Phase 1
Completed
Conditions
Interventions
First Posted Date
2017-12-11
Last Posted Date
2022-11-03
Lead Sponsor
Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company
Target Recruit Count
12
Registration Number
NCT03368196
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

🇨🇳

Taipei Veterans General Hospital, Taipei, Taiwan

Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer

Phase 1
Completed
Conditions
Interventions
First Posted Date
2017-12-08
Last Posted Date
2022-04-12
Lead Sponsor
Daiichi Sankyo Co., Ltd.
Target Recruit Count
51
Registration Number
NCT03366428
Locations
🇯🇵

Kanagawa Cancer Center, Yokohama, Kanagawa, Japan

🇯🇵

Shizuoka Cancer Center, Shizuoka, Japan

🇯🇵

Toranomon Hospital, Minato-Ku, Tokyo, Japan

and more 4 locations

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]

First Posted Date
2017-11-06
Last Posted Date
2022-03-18
Lead Sponsor
Daiichi Sankyo Co., Ltd.
Target Recruit Count
233
Registration Number
NCT03329690
Locations
🇯🇵

Hirosaki University Hospital, Hirosaki, Aomori, Japan

🇯🇵

National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan

🇯🇵

Japan Community Health Care Organization Kyushu Hospital, Kitakyushu, Fukuoka, Japan

and more 63 locations

A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2017-08-14
Last Posted Date
2023-11-15
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
253
Registration Number
NCT03248492
Locations
🇺🇸

The Regents of the University of California, Los Angeles, California, United States

🇺🇸

Virginia Cancer Specialists, PC, Fairfax, Virginia, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 96 locations
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