HERTHENA-PanTumor01: a phase II study of patritumab deruxtecan (HER3-DXd) in previously treated advanced solid tumors.
Thomas Powles, Aarti Bhatia, Barbara Burtness...
https://pubmed.ncbi.nlm.nih.gov/41088723Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06172478
HERTHENA-PanTumor01: A Phase 2, Multicenter, Open-Label Study of Patritumab Deruxtecan (HER3-DXd) in Adults With Locally Advanced or Metastatic Solid Tumors
Led by Daiichi Sankyo · Updated on 2026-05-15
740
Participants Needed
85
Research Sites
57 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
Researchers are evaluating the safety and effectiveness of HER3-DXd monotherapy in adults with locally advanced unresectable or metastatic solid tumors who have previously received at least one line of systemic anticancer therapy. This proof-of-concept Phase 2 study includes multiple cancer types such as melanoma, head and neck cancer, gastric cancer, ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, lung cancer, and breast cancer. The study also examines the relationship between HER3 protein expression in tumors and the treatment's efficacy. Participants will receive HER3-DXd, an intravenous infusion given at a dose of 5.6 mg/kg every three weeks (Q3W). This monotherapy treatment continues through repeated 21-day cycles. The study is open-label and multicohort, allowing enrollment of different tumor types in separate groups. HER3-DXd pharmacokinetics and safety will also be monitored throughout the study. During the trial, participants will undergo regular evaluations including imaging scans to measure tumor response, laboratory tests, and safety assessments. Researchers will assess objective response rates, progression-free survival, overall survival, and other clinical outcomes over approximately 27 months. Pharmacokinetic data will be collected at multiple timepoints during treatment cycles. The study will also track treatment-emergent adverse events and monitor participants until disease progression, withdrawal, or death.
CONDITIONS
Brief Title
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to any study procedures
- Aged 18 years or older (or following local legal age requirements)
- Diagnosed with locally advanced unresectable or metastatic solid tumors including melanoma, head and neck cancer, gastric cancer, ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, or breast cancer
- Disease progression after at least one prior line of systemic anticancer therapy appropriate to the tumor type
- Presence of at least one measurable lesion on CT or MRI (except prostate cancer with bone-only disease)
- Provide a pretreatment tumor tissue sample meeting study requirements
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
You will not qualify if you...
- HER2-positive gastric cancer as classified by ASCO-CAP guidelines
- Nasopharyngeal cancer
- Mucosal or uveal melanoma
- History of non-infectious interstitial lung disease requiring corticosteroids, current or suspected interstitial lung disease or pneumonitis
- Clinically severe respiratory compromise from pulmonary illnesses
- Chronic systemic corticosteroids over 10 mg prednisone daily or equivalent, or immunosuppressive therapy before treatment start
- Prior treatment with anti-HER3 antibody or antibody-drug conjugate containing a topoisomerase I inhibitor
- History of other active malignancy within 3 years except adequately treated nonmelanoma skin cancer, intraepithelial carcinoma of the cervix, or curatively treated in situ disease
- Severe or uncontrolled diseases, psychiatric illness, substance abuse, or other factors that may risk participation or compliance
- Prior topoisomerase-1 inhibitor treatment in advanced or metastatic setting
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 27 months or until disease progression, death, withdrawal, or lost to follow-up
Participants receive HER3-DXd monotherapy by intravenous infusion every 3 weeks.
Infusions every 3 weeks with visits at each cycle
Trial Site Locations
Total: 85 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
West China Hospital, Sichuan University
Chengdu, China, 610098
Actively Recruiting
29
Sun Yat-sen University Cancer Center
Guangzhou, China, 510060
Actively Recruiting
30
Chu Bordeaux
Bordeaux, France, 33000
Actively Recruiting
31
Centre Georges Franăois Leclerc
Dijon, France, 21079
Actively Recruiting
32
Hopital Claude Huriez - Chu Lille
Lille, France, 59000
Actively Recruiting
33
Centre Léon Bérard
Lyon, France, 69008
Actively Recruiting
34
Hăpital de La Timone
Marseille, France, 13005
Actively Recruiting
35
Chu Nantes - Hătel Dieu
Nantes, France, 44093
Actively Recruiting
36
Institut Claudius Regaud
Toulouse, France, 31100
Actively Recruiting
37
ICL - Alexis Vautrin
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
38
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
39
Krankenhaus Nordwest GmbH
Frankfurt, Germany, 60488
Actively Recruiting
40
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemét, Hungary, 6000
Actively Recruiting
41
Humanitas Gavazzeni
Bergamo, Italy, 24125
Actively Recruiting
42
IRCCS Ospedale Policlinico San Martino
Genova, Italy, 16132
Actively Recruiting
43
AOU Federico II - Oncologia Clinica
Naples, Italy, 80131
Actively Recruiting
44
Centro Ricerche Cliniche di Verona s.r.l.
Verona, Italy, 37134
Actively Recruiting
45
Saitama Medical University International Medical Center
Hidaka, Japan, 350-1298
Actively Recruiting
46
National Cancer Center Hospital East
Kashiwa-shi, Japan, 277-8577
Actively Recruiting
47
NHO Shikoku Cancer Center
Matsuyama, Japan, 791-0245
Actively Recruiting
48
Shizuoka Cancer Center
Nagaizumi-cho, Japan, 411-8777
Actively Recruiting
49
Aichi Cancer Center Hospital
Nagoya, Japan, 464-8681
Actively Recruiting
50
Kindai University Hospital
Osakasayama-shi, Japan, 589-8511
Actively Recruiting
51
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Actively Recruiting
52
Cancer Institute Hospital of JFCR
Tokyo, Japan, 135-8550
Actively Recruiting
53
Yokohama City University Medical Center
Yokohama, Japan, 232-0024
Actively Recruiting
54
Amsterdam UMC locatie Vumc
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
55
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
56
Leids Universitair Medisch Centrum
Leiden, Netherlands, 2333 ZG
Actively Recruiting
57
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
Actively Recruiting
58
Radboud University Medical Center
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
59
Akershus universitetssykehus
Lørenskog, Norway, 1478
Actively Recruiting
60
Haukeland universitetssjukehus
Lørenskog, Norway, 1478
Actively Recruiting
61
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, Norway, 0379
Actively Recruiting
62
Cha Bundang Medical Center, Cha University
Seongnam, South Korea, 13496
Actively Recruiting
63
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Actively Recruiting
64
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
65
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
66
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
67
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
68
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
Actively Recruiting
69
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
70
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
71
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28009
Actively Recruiting
72
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
73
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
74
HOSPITAL REGIONAL UNIVERSITARIO de MALAGA AVDA.
Málaga, Spain, 29010
Actively Recruiting
75
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
76
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
77
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833
Actively Recruiting
78
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
79
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
80
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
81
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Actively Recruiting
82
University Hospital Coventry
Coventry, United Kingdom, CV2 2DX
Actively Recruiting
83
Barts Hospital
London, United Kingdom, EC1A 7BE
Actively Recruiting
84
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
85
Nottingham City Hospital Campus
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
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Research Team
D
Daiichi Sankyo Contact for Clinical Trial Information
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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