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DRUG:
Enhertu (fam-trastuzumab deruxtecan-nxki)
i
Other names:
DS-8201, DS-8201a, WHO 10516, T-DXd, DS8201, DS 8201, DS8201a, DS 8201a, TDXd, T DXd, WHO10516, WHO-10516
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Associations
(90)
News
Trials
Company:
AstraZeneca, Daiichi Sankyo
Drug class:
Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate
Related drugs:
‹
irinotecan (48)
U3-1402 (28)
sacituzumab govitecan-hziy (17)
topotecan (16)
SHR-A1811 (15)
datopotamab deruxtecan (11)
DM001 (6)
DS-7300 (5)
AZD8205 (5)
AMB302 (4)
DB-1310 (4)
DM002 (4)
BNT323 (4)
BL-M07D1 (3)
DS-6157 (3)
HRA00129-C004 (3)
sacituzumab tirumotecan (3)
nanoliposomal irinotecan (3)
PLX038 (3)
ABBV-400 (3)
CUSP06 (2)
DAN-222 (2)
DM005 (2)
PRO1102 (2)
SSH20 (2)
IMMU-130 (2)
AZD9592 (2)
AMT-562 (1)
AZD5335 (1)
BAT8008 (1)
BL-M02D1 (1)
BNT324 (1)
camptothecin nanosomal (1)
DAN-311 (1)
ELU001 (1)
HMBD-501 (1)
IMMU-140 (1)
IT-141 (1)
OBI-992 (1)
OQY-3258 (1)
PF-08046044 (1)
rinatabart sesutecan (1)
SGN-CD30C (1)
SHR-A2102 (1)
STRO-003 (1)
ZW191 (1)
ZW220 (1)
ZW251 (1)
IBI-343 (1)
BL-B01D1 (1)
ABBV-706 (0)
ARC-401 (0)
BAT8007 (0)
BAT8010 (0)
BL-M11D1 (0)
BNT326 (0)
CEB-01 (0)
belotecan (0)
DS-3939 (0)
FZ-AD004 (0)
GEN1160 (0)
GSK5733584 (0)
GSK5764227 (0)
HA-irinotecan (0)
HLX43 (0)
IBI-354 (0)
ICAM‑1 ADC (0)
JSKN003 (0)
LMP744 (0)
LY4170156 (0)
lentinan (0)
TLC388 (0)
MHB036C (0)
MHB088C (0)
NK012 (0)
etirinotecan pegol (0)
SHR-A1904 (0)
SHR-A1912 (0)
SHR-A2009 (0)
SKB315 (0)
TQB2102 (0)
TQB2103 (0)
VIP236 (0)
YL201 (0)
CBX-12 (0)
EP0057 (0)
LMP400 (0)
HR070803 (0)
irinotecan liposomal (0)
LY01616 (0)
FF-10850 (0)
PEN-866 (0)
SSS22 (0)
M9140 (0)
DS-6000 (0)
simmitecan (0)
SHR-A1921 (0)
topotecan episcleral (0)
ado-trastuzumab emtansine (97)
disitamab vedotin (27)
JNJ-0683 (9)
trastuzumab duocarmazine (6)
A166 (6)
MM-302 (4)
PF-06804103 (4)
SBT6050 (4)
XMT-1522 (3)
IKS014 (3)
MRG002 (3)
ZW49 (3)
BB-1701 (2)
ORM-5029 (2)
XMT-2056 (2)
DP303c (2)
ADC2122 (1)
ALT-P7 (1)
BAT8001 (1)
DHES0815A (1)
GQ1001 (1)
MEDI4276 (1)
MF-TTZ-MMAE (1)
MYX2449 (1)
TAA013 (1)
Ujvira (trastuzumab emtansine biosimilar) (1)
YH012 (1)
BT2111 (1)
ADCT-502 (0)
DX126-262 (0)
GQ1007 (0)
SHR-4602 (0)
SHR-A1201 (trastuzumab emtansine biosimilar) (0)
BI-CON-02 (0)
irinotecan (48)
U3-1402 (28)
sacituzumab govitecan-hziy (17)
topotecan (16)
SHR-A1811 (15)
datopotamab deruxtecan (11)
DM001 (6)
DS-7300 (5)
AZD8205 (5)
AMB302 (4)
DB-1310 (4)
DM002 (4)
BNT323 (4)
BL-M07D1 (3)
DS-6157 (3)
HRA00129-C004 (3)
sacituzumab tirumotecan (3)
nanoliposomal irinotecan (3)
PLX038 (3)
ABBV-400 (3)
CUSP06 (2)
DAN-222 (2)
DM005 (2)
PRO1102 (2)
SSH20 (2)
IMMU-130 (2)
AZD9592 (2)
AMT-562 (1)
AZD5335 (1)
BAT8008 (1)
BL-M02D1 (1)
BNT324 (1)
camptothecin nanosomal (1)
DAN-311 (1)
ELU001 (1)
HMBD-501 (1)
IMMU-140 (1)
IT-141 (1)
OBI-992 (1)
OQY-3258 (1)
PF-08046044 (1)
rinatabart sesutecan (1)
SGN-CD30C (1)
SHR-A2102 (1)
STRO-003 (1)
ZW191 (1)
ZW220 (1)
ZW251 (1)
IBI-343 (1)
BL-B01D1 (1)
ABBV-706 (0)
ARC-401 (0)
BAT8007 (0)
BAT8010 (0)
BL-M11D1 (0)
BNT326 (0)
CEB-01 (0)
belotecan (0)
DS-3939 (0)
FZ-AD004 (0)
GEN1160 (0)
GSK5733584 (0)
GSK5764227 (0)
HA-irinotecan (0)
HLX43 (0)
IBI-354 (0)
ICAM‑1 ADC (0)
JSKN003 (0)
LMP744 (0)
LY4170156 (0)
lentinan (0)
TLC388 (0)
MHB036C (0)
MHB088C (0)
NK012 (0)
etirinotecan pegol (0)
SHR-A1904 (0)
SHR-A1912 (0)
SHR-A2009 (0)
SKB315 (0)
TQB2102 (0)
TQB2103 (0)
VIP236 (0)
YL201 (0)
CBX-12 (0)
EP0057 (0)
LMP400 (0)
HR070803 (0)
irinotecan liposomal (0)
LY01616 (0)
FF-10850 (0)
PEN-866 (0)
SSS22 (0)
M9140 (0)
DS-6000 (0)
simmitecan (0)
SHR-A1921 (0)
topotecan episcleral (0)
ado-trastuzumab emtansine (97)
disitamab vedotin (27)
JNJ-0683 (9)
trastuzumab duocarmazine (6)
A166 (6)
MM-302 (4)
PF-06804103 (4)
SBT6050 (4)
XMT-1522 (3)
IKS014 (3)
MRG002 (3)
ZW49 (3)
BB-1701 (2)
ORM-5029 (2)
XMT-2056 (2)
DP303c (2)
ADC2122 (1)
ALT-P7 (1)
BAT8001 (1)
DHES0815A (1)
GQ1001 (1)
MEDI4276 (1)
MF-TTZ-MMAE (1)
MYX2449 (1)
TAA013 (1)
(1)
YH012 (1)
BT2111 (1)
ADCT-502 (0)
DX126-262 (0)
GQ1007 (0)
SHR-4602 (0)
(0)
BI-CON-02 (0)
›
Associations
(90)
News
Trials
Phase
Status
Apply
Phase
Status
Apply
DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer (KEYNOTE-797) (NCT04042701)
Phase 1
Daiichi Sankyo
Daiichi Sankyo
Active, not recruiting
Phase 1
Daiichi Sankyo
Active, not recruiting
Last update posted :
02/24/2025
Initiation :
02/10/2020
Primary completion :
07/01/2025
Completion :
08/01/2025
EGFR • HER-2 • BRAF • ALK • ROS1
|
HER-2 positive • BRAF V600E • EGFR mutation • HR positive • BRAF V600 • HER-2 expression • HER-2 underexpression • ALK mutation • ROS1 fusion
|
Keytruda (pembrolizumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)
Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies (CERTIS1) (NCT05417594)
Phase 1/2
AstraZeneca
AstraZeneca
Recruiting
Phase 1/2
AstraZeneca
Recruiting
Last update posted :
02/19/2025
Initiation :
06/24/2022
Primary completion :
08/28/2026
Completion :
08/28/2026
HER-2 • BRCA1 • BRCA2 • IDH1 • IDH2 • HRD • BRCA • RAD51C • RAD51D
|
HER-2 negative • PALB2 mutation • RAD51C mutation • RAD51D mutation
|
temozolomide • Enhertu (fam-trastuzumab deruxtecan-nxki) • Datroway (datopotamab deruxtecan) • AZD9574
A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer (HER2CLIMB-04) (NCT04539938)
Phase 2
Seagen, a wholly owned subsidiary of Pfizer
Seagen, a wholly owned subsidiary of Pf...
Active, not recruiting
Phase 2
Seagen, a wholly owned subsidiary of Pfizer
Active, not recruiting
Last update posted :
02/19/2025
Initiation :
12/01/2020
Primary completion :
07/15/2024
Completion :
07/01/2025
HER-2
|
Enhertu (fam-trastuzumab deruxtecan-nxki) • Tukysa (tucatinib)
Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Patients With Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial (NCT04704661)
Phase 1
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Recruiting
Phase 1
National Cancer Institute (NCI)
Recruiting
Last update posted :
02/19/2025
Initiation :
08/09/2021
Primary completion :
03/31/2026
Completion :
03/31/2026
HER-2 • TP53 • ATM • RAS • CD4
|
HER-2 positive • TP53 mutation • HER-2 amplification • HER-2 expression • RAS mutation
|
Enhertu (fam-trastuzumab deruxtecan-nxki) • ceralasertib (AZD6738)
An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis (NCT05376878)
Phase 4
City of Hope Medical Center
City of Hope Medical Center
Recruiting
Phase 4
City of Hope Medical Center
Recruiting
Last update posted :
02/18/2025
Initiation :
12/21/2022
Primary completion :
02/25/2026
Completion :
02/25/2026
HER-2
|
HER-2 positive
|
Herceptin (trastuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Trazimera (trastuzumab-qyyp)
Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) (NCT05845450)
Phase 2
Gruppo Oncologico del Nord-Ovest
Gruppo Oncologico del Nord-Ovest
Recruiting
Phase 2
Gruppo Oncologico del Nord-Ovest
Recruiting
Last update posted :
02/17/2025
Initiation :
05/11/2023
Primary completion :
05/01/2026
Completion :
05/01/2028
HER-2 • KRAS • BRAF • TMB • MSI • POLE • POLD1
|
HER-2 positive • MSI-H/dMMR • KRAS G12C • HER-2 amplification • HER-2 mutation • POLE mutation • KRAS wild-type • RAS wild-type • KRAS G12 • POLD1 mutation • HER-2 positive + HER-2 overexpression • HER-2 positive + RAS wild-type
|
Imfinzi (durvalumab) • Vectibix (panitumumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lumakras (sotorasib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer (DESTINY-Breast07) (NCT04538742)
Phase 1/2
AstraZeneca
AstraZeneca
Active, not recruiting
Phase 1/2
AstraZeneca
Active, not recruiting
Last update posted :
02/14/2025
Initiation :
12/28/2020
Primary completion :
01/31/2025
Completion :
01/31/2030
HER-2 • PGR
|
HER-2 positive • HR positive
|
Imfinzi (durvalumab) • paclitaxel • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Tukysa (tucatinib)
Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DO-01) (NCT06819007)
Phase 3
Daiichi Sankyo
Daiichi Sankyo
Not yet recruiting
Phase 3
Daiichi Sankyo
Not yet recruiting
Last update posted :
02/11/2025
Initiation :
03/01/2025
Primary completion :
11/01/2028
Completion :
01/31/2032
HER-2
|
Avastin (bevacizumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)
NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer (ADAPTHER2-IV) (NCT05704829)
Phase 2
West German Study Group
West German Study Group
Recruiting
Phase 2
West German Study Group
Recruiting
Last update posted :
02/11/2025
Initiation :
02/05/2024
Primary completion :
06/01/2026
Completion :
06/01/2028
HER-2
|
carboplatin • docetaxel • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer (DESTINY-BTC01) (NCT06467357)
Phase 3
AstraZeneca
AstraZeneca
Recruiting
Phase 3
AstraZeneca
Recruiting
Last update posted :
02/11/2025
Initiation :
08/12/2024
Primary completion :
06/12/2028
Completion :
05/16/2029
HER-2
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • rilvegostomig (AZD2936)
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (Morpheus-TNBC) (NCT03424005)
Phase 1/2
Hoffmann-La Roche
Hoffmann-La Roche
Recruiting
Phase 1/2
Hoffmann-La Roche
Recruiting
Last update posted :
02/10/2025
Initiation :
03/30/2018
Primary completion :
05/03/2028
Completion :
05/03/2028
HER-2 • PD-L1 • PIK3CA
|
PD-L1 expression • PIK3CA mutation
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Verzenio (abemaciclib) • albumin-bound paclitaxel • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • letrozole • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Itovebi (inavolisib) • Actemra IV (tocilizumab) • ladiratuzumab vedotin (SGN-LIV1A) • selicrelumab (RG7876)
Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer (NCT05633979)
Phase 1
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Recruiting
Phase 1
M.D. Anderson Cancer Center
Recruiting
Last update posted :
02/10/2025
Initiation :
02/09/2023
Primary completion :
12/31/2030
Completion :
12/31/2032
HER-2 • UGT1A1
|
Enhertu (fam-trastuzumab deruxtecan-nxki) • Ezharmia (valemetostat)
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) (NCT04379596)
Phase 2
AstraZeneca
AstraZeneca
Recruiting
Phase 2
AstraZeneca
Recruiting
Last update posted :
02/07/2025
Initiation :
06/03/2020
Primary completion :
07/30/2026
Completion :
07/30/2026
HER-2
|
HER-2 positive
|
Keytruda (pembrolizumab) • Herceptin (trastuzumab) • cisplatin • Imfinzi (durvalumab) • 5-fluorouracil • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • oxaliplatin • rilvegostomig (AZD2936) • volrustomig (MEDI5752)
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer (DESTINY-Breast11) (NCT05113251)
Phase 3
AstraZeneca
AstraZeneca
Active, not recruiting
Phase 3
AstraZeneca
Active, not recruiting
Last update posted :
02/05/2025
Initiation :
10/25/2021
Primary completion :
03/12/2025
Completion :
04/30/2027
HER-2
|
HER-2 positive
|
Herceptin (trastuzumab) • paclitaxel • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • doxorubicin hydrochloride • cyclophosphamide • Herzuma (trastuzumab-pkrb) • cyclophosphamide intravenous
A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer (DESTINY-Breast08) (NCT04556773)
Phase 1
AstraZeneca
AstraZeneca
Active, not recruiting
Phase 1
AstraZeneca
Active, not recruiting
Last update posted :
02/05/2025
Initiation :
12/17/2020
Primary completion :
08/16/2023
Completion :
12/04/2025
HER-2 • PGR
|
HER-2 expression • HER-2 underexpression • PGR positive
|
Imfinzi (durvalumab) • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • fulvestrant • Truqap (capivasertib) • anastrozole
Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer (NCT04294628)
Phase 1
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Active, not recruiting
Phase 1
National Cancer Institute (NCI)
Active, not recruiting
Last update posted :
01/29/2025
Initiation :
09/01/2020
Primary completion :
12/31/2025
Completion :
12/31/2025
CD4
|
HER-2 positive • HER-2 amplification • HER-2 expression
|
Enhertu (fam-trastuzumab deruxtecan-nxki)
Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer (DS8201-A-U105) (NCT03523572)
Phase 1
Daiichi Sankyo
Daiichi Sankyo
Completed
Phase 1
Daiichi Sankyo
Completed
Last update posted :
01/27/2025
Initiation :
08/02/2018
Primary completion :
07/22/2021
Completion :
09/12/2023
HER-2
|
HER-2 positive • HER-2 expression
|
Opdivo (nivolumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer (ARTEMIDE-Gastric01) (NCT06764875)
Phase 3
AstraZeneca
AstraZeneca
Not yet recruiting
Phase 3
AstraZeneca
Not yet recruiting
Last update posted :
01/09/2025
Initiation :
03/28/2025
Primary completion :
04/27/2029
Completion :
12/09/2030
PD-L1
|
Keytruda (pembrolizumab) • cisplatin • 5-fluorouracil • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • oxaliplatin • rilvegostomig (AZD2936)
A Multi-center Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer (NCT06767436)
Phase N/A
Yonsei University
Yonsei University
Recruiting
Phase N/A
Yonsei University
Recruiting
Last update posted :
01/09/2025
Initiation :
11/05/2024
Primary completion :
11/04/2025
Completion :
11/04/2025
HER-2
|
HER-2 positive
|
Enhertu (fam-trastuzumab deruxtecan-nxki)
Adjuvant Trastuzumab Deruxtecan (Enhertu) & Nivolumab For Patients Who Are Disease Free After Completion of Trimodality Treatment For HER-2+ Cancers of Esophagus & Gastroesophageal Junction (NCT05480384)
Phase 2
Brown University
Brown University
Recruiting
Phase 2
Brown University
Recruiting
Last update posted :
11/25/2024
Initiation :
07/14/2023
Primary completion :
01/01/2025
Completion :
01/01/2027
HER-2
|
HER-2 overexpression • HER-2 amplification
|
Opdivo (nivolumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08) (NCT05824975)
Phase 1/2
GI Innovation, Inc.
GI Innovation, Inc.
Recruiting
Phase 1/2
GI Innovation, Inc.
Recruiting
Last update posted :
11/25/2024
Initiation :
05/30/2023
Primary completion :
11/12/2025
Completion :
04/24/2027
CD8 • CD4
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • doxorubicin hydrochloride • Halaven (eribulin mesylate)
Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer (DESTINY-CRC02) (NCT04744831)
Phase 2
Daiichi Sankyo
Daiichi Sankyo
Completed
Phase 2
Daiichi Sankyo
Completed
Last update posted :
11/19/2024
Initiation :
03/05/2021
Primary completion :
11/01/2022
Completion :
10/08/2024
EGFR • HER-2 • BRAF • TMB • MSI
|
MSI-H/dMMR • HER-2 overexpression • BRAF wild-type • RAS wild-type • HER-2 positive + RAS wild-type
|
Enhertu (fam-trastuzumab deruxtecan-nxki)
Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer (DECIPHER) (NCT05965479)
Phase 2
University of Southampton
University of Southampton
Recruiting
Phase 2
University of Southampton
Recruiting
Last update posted :
11/11/2024
Initiation :
04/10/2024
Primary completion :
03/31/2026
Completion :
04/30/2028
HER-2
|
HER-2 overexpression
|
Enhertu (fam-trastuzumab deruxtecan-nxki)
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] (NCT03523585)
Phase 3
Daiichi Sankyo
Daiichi Sankyo
Active, not recruiting
Phase 3
Daiichi Sankyo
Active, not recruiting
Last update posted :
11/05/2024
Initiation :
08/01/2018
Primary completion :
06/30/2022
Completion :
07/31/2025
HER-2
|
HER-2 positive • HER-2 expression
|
lapatinib • Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine
Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (DESTINY-LUNG02) (NCT04644237)
Phase 2
Daiichi Sankyo
Daiichi Sankyo
Completed
Phase 2
Daiichi Sankyo
Completed
Last update posted :
10/24/2024
Initiation :
03/19/2021
Primary completion :
12/23/2022
Completion :
08/23/2024
HER-2
|
HER-2 mutation
|
Enhertu (fam-trastuzumab deruxtecan-nxki)
Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04) (NCT04704934)
Phase 3
Daiichi Sankyo
Daiichi Sankyo
Active, not recruiting
Phase 3
Daiichi Sankyo
Active, not recruiting
Last update posted :
10/24/2024
Initiation :
05/21/2021
Primary completion :
10/01/2025
Completion :
02/01/2026
HER-2
|
HER-2 positive • HER-2 amplification
|
paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • Cyramza (ramucirumab)
A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05) (NCT04622319)
Phase 3
Daiichi Sankyo
Daiichi Sankyo
Active, not recruiting
Phase 3
Daiichi Sankyo
Active, not recruiting
Last update posted :
10/09/2024
Initiation :
12/04/2020
Primary completion :
12/31/2025
Completion :
12/31/2030
HER-2 • ER • PGR
|
HER-2 positive • HR positive • HER-2 expression • ER negative
|
Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki)
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) ( DESTINY-Breast01) (NCT03248492)
Phase 2
Daiichi Sankyo
Daiichi Sankyo
Completed
Phase 2
Daiichi Sankyo
Completed
Last update posted :
09/24/2024
Initiation :
08/25/2017
Primary completion :
03/21/2019
Completion :
05/06/2024
HER-2
|
HER-2 positive • HER-2 expression
|
Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki)
Basket Study for Oligo-metastatic Breast Cancer (ANISE) (NCT05982678)
Phase 2
The Netherlands Cancer Institute
The Netherlands Cancer Institute
Recruiting
Phase 2
The Netherlands Cancer Institute
Recruiting
Last update posted :
08/21/2024
Initiation :
05/02/2024
Primary completion :
10/01/2027
Completion :
10/01/2034
HER-2 • ER
|
HER-2 positive • HER-2 amplification
|
Enhertu (fam-trastuzumab deruxtecan-nxki)
Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype (PONTIAC) (NCT06486883)
Phase 2
MedSIR
MedSIR
Not yet recruiting
Phase 2
MedSIR
Not yet recruiting
Last update posted :
07/04/2024
Initiation :
12/01/2024
Primary completion :
01/01/2027
Completion :
01/01/2028
HER-2
|
Enhertu (fam-trastuzumab deruxtecan-nxki) • fulvestrant
A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations (DESTINY-Lung04) (NCT05048797)
Phase 3
AstraZeneca
AstraZeneca
Recruiting
Phase 3
AstraZeneca
Recruiting
Last update posted :
06/12/2024
Initiation :
10/28/2021
Primary completion :
06/30/2025
Completion :
03/29/2027
HER-2
|
HER-2 mutation
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • Enhertu (fam-trastuzumab deruxtecan-nxki) • pemetrexed
DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] (NCT03529110)
Phase 3
Daiichi Sankyo
Daiichi Sankyo
Active, not recruiting
Phase 3
Daiichi Sankyo
Active, not recruiting
Last update posted :
06/12/2024
Initiation :
08/09/2018
Primary completion :
05/21/2021
Completion :
06/01/2025
HER-2
|
HER-2 positive • HER-2 expression
|
Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki)
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03) (ACE-Breast-3) (NCT04829604)
Phase 2
Ambrx, Inc.
Ambrx, Inc.
Recruiting
Phase 2
Ambrx, Inc.
Recruiting
Last update posted :
06/11/2024
Initiation :
10/26/2021
Primary completion :
06/01/2025
Completion :
12/01/2026
HER-2
|
HER-2 positive
|
Enhertu (fam-trastuzumab deruxtecan-nxki) • Tukysa (tucatinib) • anvatabart opadotin (JNJ-0683)
ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer (NCT05650879)
Phase 1
Enliven Therapeutics
Enliven Therapeutics
Recruiting
Phase 1
Enliven Therapeutics
Recruiting
Last update posted :
06/07/2024
Initiation :
03/20/2023
Primary completion :
07/01/2026
Completion :
07/01/2026
BRAF • ALK • ROS1
|
HER-2 positive • BRAF V600E • HER-2 amplification • BRAF V600 • ALK mutation
|
Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • ELVN-002
Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma (NCT04616560)
Phase 2
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Suspended
Phase 2
National Cancer Institute (NCI)
Suspended
Last update posted :
06/06/2024
Initiation :
03/08/2021
Primary completion :
03/31/2025
Completion :
03/31/2025
HER-2
|
HER-2 expression
|
Enhertu (fam-trastuzumab deruxtecan-nxki)
Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene (NCI-2022-04099) (NCT05372614)
Phase 1
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Recruiting
Phase 1
National Cancer Institute (NCI)
Recruiting
Last update posted :
06/05/2024
Initiation :
10/05/2022
Primary completion :
06/17/2024
Completion :
06/17/2024
HER-2 • CD4 • CASP3
|
HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 L755S • HER-2 A775_G776insYVMA • HER-2 S310F • HER-2 V777L • HER-2 G778_P780dup • HER-2 D769Y • HER-2 L869R • HER-2 V842I • HER-2 H878Y • HER-2 L866M • HER-2 A775 • HER-2 G309A • HER-2 P780-Y781insGSP • HER-2 R678Q • HER-2 R896C • HER-2 T862A • HER-2 YVMA
|
Nerlynx (neratinib) • Enhertu (fam-trastuzumab deruxtecan-nxki)
Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Endometrial Cancer (NCT04585958)
Phase 1
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Suspended
Phase 1
National Cancer Institute (NCI)
Suspended
Last update posted :
06/05/2024
Initiation :
05/21/2021
Primary completion :
06/30/2024
Completion :
06/30/2024
HER-2 • CD4
|
HER-2 positive • HER-2 negative • HER-2 expression
|
Lynparza (olaparib) • Enhertu (fam-trastuzumab deruxtecan-nxki)
A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN) (NCT06100874)
Phase 2
Adrienne G. Waks
Adrienne G. Waks
Recruiting
Phase 2
Adrienne G. Waks
Recruiting
Last update posted :
05/30/2024
Initiation :
11/20/2023
Primary completion :
11/30/2026
Completion :
11/30/2027
HER-2
|
PGR expression
|
Herceptin (trastuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Trodelvy (sacituzumab govitecan-hziy) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer (BEGONIA) (NCT03742102)
Phase 1/2
AstraZeneca
AstraZeneca
Recruiting
Phase 1/2
AstraZeneca
Recruiting
Last update posted :
05/21/2024
Initiation :
12/21/2018
Primary completion :
11/14/2024
Completion :
11/14/2024
HER-2 • PD-L1
|
PD-L1 expression • HER-2 expression • PD-L1 expression + HER-2 overexpression
|
Imfinzi (durvalumab) • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • Truqap (capivasertib) • Datroway (datopotamab deruxtecan) • oleclumab (MEDI9447)
T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases (TUXEDO-4) (NCT06048718)
Phase 2
MedSIR
MedSIR
Not yet recruiting
Phase 2
MedSIR
Not yet recruiting
Last update posted :
05/16/2024
Initiation :
05/31/2024
Primary completion :
09/01/2025
Completion :
07/01/2026
HER-2
|
Enhertu (fam-trastuzumab deruxtecan-nxki)
Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer (NCT06085755)
Phase 1/2
Jeeyun Lee
Jeeyun Lee
Not yet recruiting
Phase 1/2
Jeeyun Lee
Not yet recruiting
Last update posted :
05/14/2024
Initiation :
06/01/2024
Primary completion :
12/01/2025
Completion :
12/01/2026
HER-2
|
Gilotrif (afatinib) • Enhertu (fam-trastuzumab deruxtecan-nxki)
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer (NCT06058988)
Phase 2
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Recruiting
Phase 2
Memorial Sloan Kettering Cancer Center
Recruiting
Last update posted :
05/13/2024
Initiation :
09/22/2023
Primary completion :
09/22/2027
Completion :
09/22/2027
HER-2
|
HER-2 mutation • HER-2 expression
|
Enhertu (fam-trastuzumab deruxtecan-nxki)
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