Actively Recruiting
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
Led by Daiichi Sankyo · Updated on 2026-01-28
740
Participants Needed
84
Research Sites
241 weeks
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \[cutaneous/acral\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.
CONDITIONS
Official Title
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sign and date the informed consent form before any study procedures
- Be 18 years or older (or meet local legal age for consent if above 18)
- Have locally advanced unresectable or metastatic disease of specific tumor types confirmed by histology or cytology
- Have disease progression after prior systemic therapies as specified for each tumor type
- Have measurable lesions on CT or MRI per RECIST v1.1 (prostate cancer participants with bone-only disease may be eligible)
- Provide pretreatment tumor tissue sample either archival or fresh biopsy
- Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening
You will not qualify if you...
- Have HER2-positive gastric cancer
- Have nasopharyngeal cancer
- Have mucosal or uveal melanoma
- Have a history of interstitial lung disease requiring corticosteroids or current/suspected ILD
- Have severe respiratory compromise from lung illnesses
- Are receiving chronic systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive therapy prior to Cycle 1 Day 1
- Have prior treatment with anti-HER3 antibody or related antibody-drug conjugates containing a topoisomerase I inhibitor
- Have history of other active malignancy within 3 years except adequately treated nonmelanoma skin cancer, intraepithelial carcinoma of the cervix, or other curatively treated in situ disease
- Have severe or uncontrolled diseases, psychiatric illness, social situations, substance abuse, or other factors risking study compliance
- Have received topoisomerase-1 inhibitors in advanced or metastatic disease setting
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 84 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
AdventHealth Medical Group Oncology Research at Celebration
Kissimmee, Florida, United States, 34747
Actively Recruiting
4
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
5
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
6
Health Partners Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States, 55426
Actively Recruiting
7
Health Partners Cancer Center at Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
8
Washington University, School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
9
Roswell Park Cancer Institute IDS
Buffalo, New York, United States, 14203
Actively Recruiting
10
Memorial Sloan Kettering Hospital
New York, New York, United States, 10065
Actively Recruiting
11
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
13
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
14
Chris O'Brien Lifehouse
Camperdown, Australia, 2050
Actively Recruiting
15
Icon Cancer Centre Chermside
Chermside, Australia, 4032
Actively Recruiting
16
Monash Medical Centre Clayton
Clayton, Australia, 3168
Actively Recruiting
17
Icon Cancer Centre Hobart
Hobart, Australia, 7000
Actively Recruiting
18
Icon Cancer Centre Townsville
Hyde Park, Australia, 4812
Actively Recruiting
19
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Actively Recruiting
20
UZA
Edegem, Belgium, 2650
Actively Recruiting
21
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
22
Universitair Ziekenhuis Brussel
Jette, Belgium
Actively Recruiting
23
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
24
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
25
Sunnybrook Research Institute
Toronto, Canada, M4N 3M5
Actively Recruiting
26
Princess Margaret Cancer Centre
Toronto, Canada, M5G2M9
Actively Recruiting
27
BC Cancer - Vancouver
Vancouver, Canada, V5Z4E6
Actively Recruiting
28
Sun Yat-sen University Cancer Center
Guangzhou, China, 510060
Actively Recruiting
29
Chu Bordeaux
Bordeaux, France, 33000
Actively Recruiting
30
Centre Georges Franăois Leclerc
Dijon, France, 21079
Actively Recruiting
31
Hopital Claude Huriez - Chu Lille
Lille, France, 59000
Actively Recruiting
32
Centre Léon Bérard
Lyon, France, 69008
Actively Recruiting
33
Hăpital de La Timone
Marseille, France, 13005
Actively Recruiting
34
Chu Nantes - Hătel Dieu
Nantes, France, 44093
Actively Recruiting
35
Institut Claudius Regaud
Toulouse, France, 31100
Actively Recruiting
36
ICL - Alexis Vautrin
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
37
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
38
Krankenhaus Nordwest GmbH
Frankfurt, Germany, 60488
Actively Recruiting
39
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemét, Hungary, 6000
Actively Recruiting
40
Humanitas Gavazzeni
Bergamo, Italy, 24125
Actively Recruiting
41
IRCCS Ospedale Policlinico San Martino
Genova, Italy, 16132
Actively Recruiting
42
AOU Federico II - Oncologia Clinica
Naples, Italy, 80131
Actively Recruiting
43
Centro Ricerche Cliniche di Verona s.r.l.
Verona, Italy, 37134
Actively Recruiting
44
Saitama Medical University International Medical Center
Hidaka, Japan, 350-1298
Actively Recruiting
45
National Cancer Center Hospital East
Kashiwa-shi, Japan, 277-8577
Actively Recruiting
46
NHO Shikoku Cancer Center
Matsuyama, Japan, 791-0245
Actively Recruiting
47
Shizuoka Cancer Center
Nagaizumi-cho, Japan, 411-8777
Actively Recruiting
48
Aichi Cancer Center Hospital
Nagoya, Japan, 464-8681
Actively Recruiting
49
Kindai University Hospital
Osakasayama-shi, Japan, 589-8511
Actively Recruiting
50
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Actively Recruiting
51
Cancer Institute Hospital of JFCR
Tokyo, Japan, 135-8550
Actively Recruiting
52
Yokohama City University Medical Center
Yokohama, Japan, 232-0024
Actively Recruiting
53
Amsterdam UMC locatie Vumc
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
54
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
55
Leids Universitair Medisch Centrum
Leiden, Netherlands, 2333 ZG
Actively Recruiting
56
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
Actively Recruiting
57
Radboud University Medical Center
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
58
Akershus universitetssykehus
Lørenskog, Norway, 1478
Actively Recruiting
59
Haukeland universitetssjukehus
Lørenskog, Norway, 1478
Actively Recruiting
60
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, Norway, 0379
Actively Recruiting
61
Cha Bundang Medical Center, Cha University
Seongnam, South Korea, 13496
Actively Recruiting
62
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Actively Recruiting
63
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
64
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
65
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
66
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
67
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
Actively Recruiting
68
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
69
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
70
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28009
Actively Recruiting
71
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
72
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
73
HOSPITAL REGIONAL UNIVERSITARIO de MALAGA AVDA.
Málaga, Spain, 29010
Actively Recruiting
74
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
75
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
76
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833
Actively Recruiting
77
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
78
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
79
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
80
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Actively Recruiting
81
University Hospital Coventry
Coventry, United Kingdom, CV2 2DX
Actively Recruiting
82
Barts Hospital
London, United Kingdom, EC1A 7BE
Actively Recruiting
83
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
84
Nottingham City Hospital Campus
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
Research Team
D
Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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