Actively Recruiting
A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
Led by Daiichi Sankyo · Updated on 2026-02-12
520
Participants Needed
119
Research Sites
223 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 study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; and cutaneous melanoma.
CONDITIONS
Official Title
A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must have at least 1 lesion suitable for biopsy and consent to provide a pretreatment biopsy or have an archival tumor tissue sample within 6 months after progression on previous therapy.
- Participants must be 18 years or older.
- At least 1 measurable lesion on CT or MRI according to RECIST v1.1.
- Documented radiological disease progression after previous standard-of-care treatment for advanced/metastatic cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Additional tumor-specific criteria apply, including prior therapy requirements and tumor characteristics for endometrial cancer, head and neck squamous cell carcinoma, pancreatic adenocarcinoma, colorectal cancer, hepatocellular carcinoma, adenocarcinoma of esophagus, gastroesophageal junction and stomach, urothelial carcinoma, cervical cancer, ovarian cancer, biliary tract cancer, HER2-low and HER2 IHC 0 breast cancer, and cutaneous melanoma as detailed in the protocol.
You will not qualify if you...
- Prior treatment with orlotamab, enoblituzumab, or other B7-H3-targeted agents, including I-DXd.
- Prior discontinuation of an antibody drug conjugate containing an exatecan derivative due to treatment-related toxicities.
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis that are untreated, symptomatic, or require steroid or anticonvulsant therapy.
- Inadequate washout period from prior treatments as specified in the protocol.
AI-Screening
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Trial Site Locations
Total: 119 locations
1
Los Angeles Cancer Network
Los Angeles, California, United States, 90017
Actively Recruiting
2
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Active, Not Recruiting
3
Pih Health Hematology Medical Oncology
Whittier, California, United States, 90602
Actively Recruiting
4
Orchard Healthcare Research Inc.
Skokie, Illinois, United States, 60077
Actively Recruiting
5
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
6
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
7
Icahn School of Medicine At Mount Sinai Prime
New York, New York, United States, 10029
Actively Recruiting
8
Clinical Research Alliance
Westbury, New York, United States, 11590
Actively Recruiting
9
Tn Gynecologic Oncology Group, Llc
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
10
The West Clinic
Germantown, Tennessee, United States, 38138
Actively Recruiting
11
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
Texas Oncology - West Texas
Amarillo, Texas, United States, 79124
Actively Recruiting
13
Texas Oncology, P.A.
Dallas, Texas, United States, 75246
Actively Recruiting
14
Texas Oncology Gulf Coast
Pearland, Texas, United States, 77584
Actively Recruiting
15
University of Utah Hospitals & Clinics
Salt Lake City, Utah, United States, 84108
Actively Recruiting
16
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
17
Wenatchee Hospitals and Clinics
Wenatchee, Washington, United States, 98801
Actively Recruiting
18
DIABAID
Buenos Aires, Argentina, C1061ABD
Not Yet Recruiting
19
Hospital Aleman
Buenos Aires, Argentina, C1118AAT
Actively Recruiting
20
Hospital Sirio Libanes
Caba, Argentina, C1419GEP
Actively Recruiting
21
Centro Médico Austral
Ciudad Autonoma Buenos Aires, Argentina, 1019
Actively Recruiting
22
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, Argentina, 7600
Actively Recruiting
23
Genesiscare North Shore Oncology
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
24
Blacktown Hospital
Blacktown, Australia, NSW 2148
Actively Recruiting
25
St Vincent'S Hospital Sydney
Mount Kuring-Gai, Australia, 2080
Actively Recruiting
26
St John of God Subiaco Hospital
Subiaco, Australia, 6008
Actively Recruiting
27
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Actively Recruiting
28
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
29
Grand Hospital de Charleroi
Charleroi, Belgium, 6000
Actively Recruiting
30
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Not Yet Recruiting
31
Uz Leuven
Leuven, Belgium, 3000
Actively Recruiting
32
Chu de Liă Ge
Liège, Belgium, 4000
Not Yet Recruiting
33
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos, Brazil, 14784-400
Actively Recruiting
34
Cepon - Centro de Pesquisas Oncolă"Gicas de Santa Catarina
Florianópolis, Brazil, 88034-000
Actively Recruiting
35
Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho
Jaú, Brazil, 17210-120
Actively Recruiting
36
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Actively Recruiting
37
Hospital São Lucas Da Pucrs
Porto Alegre, Brazil, 90610-000
Actively Recruiting
38
Biocenter
Concepción, Chile, 4070196
Actively Recruiting
39
Ic La Serena Research
La Serena, Chile, 1720430
Not Yet Recruiting
40
Centro Del Cancer UC
Santiago, Chile, 8320000
Actively Recruiting
41
Clinica Redsalud Vitacura
Santiago, Chile, 8320000
Actively Recruiting
42
James Lind Centro de Investigacion Del Cancer
Temuco, Chile, 4800827
Not Yet Recruiting
43
Centre Léon Bérard
Lyon, Rhone, France, 69008
Actively Recruiting
44
Chu Besançon - Hôpital Jean Minjoz
Besançon, France, 25000
Actively Recruiting
45
Hopital Saint Andre
Bordeaux, France, 33075
Actively Recruiting
46
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
47
Centre Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
48
Institut Régional Du Cancer de Montpellier
Montpellier, France, 34298
Actively Recruiting
49
Institut Curie - Site de Paris
Paris, France, 75005
Actively Recruiting
50
CRLCC Eugene Marquis
Rennes, France, 35042
Actively Recruiting
51
Ico - Site René Gauducheau
Saint-Herblain, France, 44800
Actively Recruiting
52
Institut Claudius Regaud
Toulouse, France, 31059
Not Yet Recruiting
53
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
54
Charită - Campus Charită Mitte
Berlin, Germany, 10117
Not Yet Recruiting
55
Vivantes Klinikum Neukoelln
Berlin, Germany, 12351
Actively Recruiting
56
Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
Dresden, Germany, 01067
Actively Recruiting
57
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
58
Slk-Kliniken Heilbronn Gmbh
Heilbronn, Germany, 74078
Actively Recruiting
59
Universitäres Krebszentrum Leipzig UCCL, UKL AöR
Leipzig, Germany, 04103
Actively Recruiting
60
Univ der Johannes GutenbergU
Mainz, Germany, 55131
Actively Recruiting
61
Universitätsklinikum Münster, Medizinische Klinik A
Münster, Germany, 48149
Actively Recruiting
62
Cork University Hospital
Cork, Ireland, T12DC4A
Not Yet Recruiting
63
Mater Misericordiae University Hospital
Dublin, Ireland, D07 R2WY
Actively Recruiting
64
Tallaght University Hospital
Dublin, Ireland, D24 NR0A
Actively Recruiting
65
St Vincent'S University Hospital
Dublin, Ireland, DUBLIN 4
Actively Recruiting
66
University Hospital Galway
Galway, Ireland, H91YR71
Not Yet Recruiting
67
Fondazione Del Piemonte Per L'Oncologia Irccs Candiolo
Candiolo, Italy, 10060
Actively Recruiting
68
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
69
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, Italy, 20162
Actively Recruiting
70
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy, 80131
Actively Recruiting
71
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
72
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
73
National Cancer Center Hospital
Chūōku, Japan, 104-0045
Actively Recruiting
74
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Actively Recruiting
75
The Cancer Institute Hospital of Jfcr
Kōtoku, Japan, 135-8550
Actively Recruiting
76
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan, 791-0280
Actively Recruiting
77
Shizuoka Cancer Center
Nagaizumi-cho, Japan, 411-8777
Actively Recruiting
78
Aichi Cancer Center Hospital
Nagoya, Japan, 464-0021
Actively Recruiting
79
Kindai University Hospital
Ōsaka-sayama, Japan, 589-8511
Actively Recruiting
80
Saitama Cancer Center
Saitama, Japan, 362-0806
Actively Recruiting
81
Medical Care & Research Sa de Cv
Mérida, Mexico, 97070
Not Yet Recruiting
82
Centro de Atenciă"N E Investigaciă"N Clă Nica En Oncologă A
Mérida, Mexico, 97134
Not Yet Recruiting
83
Cryptex Investigacion Clinica S.A. de C.V.
México, Mexico, 06100
Not Yet Recruiting
84
Amsterdam Umc, Locatie Vumc
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
85
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
86
Radboudumc Nijmegen
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
87
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
88
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
89
Umc Utrecht
Utrecht, Netherlands, 3584 CW
Actively Recruiting
90
SPZOZ Szpital Uniwer w Krakowie
Krakow, Poland, 30-688
Actively Recruiting
91
Instytut MSF Sp. z o.o.
Lodz, Poland, 90-302
Actively Recruiting
92
MRUK-MED i Spółka z ograniczoną odpowiedzialnością
Rzeszów, Poland, 35-021
Actively Recruiting
93
Mazowiecki Szpital Wojewodzki W Siedlcach Sp Z O O
Siedlce, Poland, 08-110
Actively Recruiting
94
Aidport Sp Z O.O.
Skorzewo, Poland, 60-185
Actively Recruiting
95
Instituto Portuguă S de Oncologia de Lisboa Francisco Gentil, Epe
Lisbon, Portugal, 1099-023
Actively Recruiting
96
Fundação Champalimaud
Lisbon, Portugal, 1400-038
Actively Recruiting
97
Centro Hospitalar Universitário de Lisboa Norte
Lisbon, Portugal, 1649-035
Actively Recruiting
98
Centro Hospitalar Universitario de Santo Antonio
Porto, Portugal, 4099-001
Actively Recruiting
99
Inst Portude Onco do Porto
Porto, Portugal, 4200-072
Actively Recruiting
100
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
101
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain, 08908
Actively Recruiting
102
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 8035
Actively Recruiting
103
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28009
Actively Recruiting
104
Hospital Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
105
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
106
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
107
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
108
China Medical University Hospital
Taichung, Taiwan, 404327
Actively Recruiting
109
National Cheng Kung University Hospitalx
Tainan, Taiwan, 70403
Actively Recruiting
110
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
111
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
112
Koo Foundation Sun Yat-Sen cancer center
Taipei, Taiwan, 11259
Actively Recruiting
113
Tri-Service General Hospital
Taipei, Taiwan, 11490
Actively Recruiting
114
Gulhane Training and Research Hospital
Ankara, Turkey (Türkiye), 06010
Actively Recruiting
115
Gazi University Medical Faculty
Ankara, Turkey (Türkiye), 06500
Actively Recruiting
116
Ankara University Cebeci Hospital
Ankara, Turkey (Türkiye), 6590
Not Yet Recruiting
117
Ankara City Hospital
Ankara, Turkey (Türkiye), 6800
Not Yet Recruiting
118
Medipol Mega University Hospital
Istanbul, Turkey (Türkiye), 34214
Actively Recruiting
119
Izmir Medicalpark Hospital
Izmir, Turkey (Türkiye), 35530
Not Yet Recruiting
Research Team
(
(US) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
(
(Asia) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
13
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