A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Start Date
4/10/2024
Completion Date
7/25/2028
Summary
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; cutaneous melanoma; and neuroendocrine carcinoma (NEC).
Detailed Description
This study will evaluate the efficacy and safety of I-DXd in participants with recurrent or metastatic solid tumors. The study will be divided into 3 parts: Stage 1, Stage 2 and an optional Stage 3. Each cohort starts with Stage 1 and may continue to Stage 2 if sufficient safety and efficacy data are observed. The EC cohort may proceed to an optional Stage 3 expansion based on the totality of available data. The HCC Safety Run-In (Phase 1) will assess the safety and tolerability of I-DXd in participants with HCC.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Ifinatamab deruxtecan
Conditions
Locations
Valkyrie Clinical Trials
Los Angeles, California 90067
United States
Los Angeles Cancer Network
Los Angeles, California 91204
United States
Pih Health Hematology Medical Oncology
Whittier, California 90602
United States
Orchard Healthcare Research Inc
Skokie, Illinois 60077
United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota 55114
United States
NYU Langone Health
New York, New York 10016
United States
Icahn School of Medicine At Mount Sinai Prime
New York, New York 10029
United States
Clinical Research Alliance, Inc
Westbury, New York 11590
United States
White Plains Hospital
White Plains, New York 10601
United States
Erlanger Health, Inc
Chattanooga, Tennessee 37403
United States
The West Clinic
Germantown, Tennessee 38138
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Texas Oncology - West Texas
Amarillo, Texas 79124
United States
Texas Oncology, P.A.
Dallas, Texas 75246
United States
Texas Oncology Gulf Coast
Pearland, Texas 77584
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah 84112
United States
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington 98801
United States
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, Buenos Aires B7600FYK
Argentina
Hospital Aleman
Buenos Aires, Ciudad Autonoma Buenos Aires C1118AAT
Argentina
Hospital Sirio Libanes
Caba, Ciudad Autonoma Buenos Aires C1419GEP
Argentina
DIABAID
Buenos Aires, C1061ABD
Argentina
Centro Médico Austral
Ciudad Autonoma Buenos Aires, 1019
Argentina
Centro de Investigaciones Medicas y Desarrollo LC SRL LC Investigacion
Ciudad Autonoma Buenos Aires, C1113AAE
Argentina
Blacktown Hospital
Blacktown, New South Wales NSW 2148
Australia
St Vincent'S Hospital Sydney
Mount Kuring-Gai, New South Wales 2080
Australia
Genesiscare North Shore Oncology
St Leonards, New South Wales 2065
Australia
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
Australia
St John of God Subiaco Hospital
Subiaco, Western Australia 6008
Australia
Cliniques Universitaires Saint-Luc
Brussels, 1200
Belgium
Grand Hospital de Charleroi
Charleroi, 6000
Belgium
Universitair Ziekenhuis Gent
Ghent, 9000
Belgium
Uz Leuven
Leuven, 3000
Belgium
Chu de Liăge
Liège, 4000
Belgium
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul 90035-903
Brazil
Hospital São Lucas Da Pucrs
Porto Alegre, Rio Grande do Sul 90610-000
Brazil
Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina
Florianópolis, Santa Catarina 88034-000
Brazil
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos, São Paulo 14784-400
Brazil
Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho
Jaú, São Paulo 17210-120
Brazil
Biocenter
Concepción, Biobio 4030000
Chile
Centro Del Cancer UC
Santiago, Santiago Metropolitan 8320000
Chile
Clinica Redsalud Vitacura
Santiago, Santiago Metropolitan 8320000
Chile
Ic La Serena Research
La Serena, 1720430
Chile
James Lind Centro de Investigacion Del Cancer
Temuco, 4800827
Chile
Centre Georges François Leclerc
Dijon, Cote dÝOr 21000
France
Hopital Saint Andre
Bordeaux, Gironde 33075
France
Institut Bergonié
Bordeaux, Gironde 33076
France
Institut Régional Du Cancer de Montpellier
Montpellier, Herault 34298
France
CRLCC Eugene Marquis
Rennes, Ille Et Vilaine 35042
France
Ico - Site René Gauducheau
Saint-Herblain, Loire Atlantique 44800
France
Institut Curie - Site de Paris
Paris, Paris 75005
France
Centre Léon Bérard
Lyon, Rhone 69008
France
GustaveRoussy DptPharmacie
Villejuif, Val De Marne 94805
France
Chu Besançon - Hôpital Jean Minjoz
Besançon, 25000
France
Institut Claudius Regaud
Toulouse, 31059
France
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg 69120
Germany
Slk-Kliniken Heilbronn Gmbh
Heilbronn, Baden-Wurttemberg 74078
Germany
Universitätsklinikum Münster, Medizinische Klinik A
Münster, North Rhine-Westphalia 48149
Germany
Univ der Johannes GutenbergU
Mainz, Rhineland-Palatinate 55131
Germany
Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
Dresden, Saxony 01067
Germany
Universitäres Krebszentrum Leipzig UCCL, UKL AöR
Leipzig, Saxony 04103
Germany
Vivantes Klinikum Neukoelln
Berlin, 12351
Germany
Charită - Campus Charită Mitte
Berlin, 13353
Germany
St Vincent'S University Hospital
Dublin, Dublin D04 T6F4
Ireland
Cork University Hospital
Cork, T12DC4A
Ireland
Mater Misericordiae University Hospital
Dublin, D07 R2WY
Ireland
Tallaght University Hospital
Dublin, D24 NR0A
Ireland
University Hospital Galway
Galway, H91YR71
Ireland
Fondazione Del Piemonte Per L'Oncologia Irccs Candiolo
Candiolo, 10060
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, 20162
Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, 80131
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
Italy
Istituto Clinico Humanitas
Rozzano, 20089
Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken 464-8681
Japan
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime 791-0280
Japan
Kindai University Hospital
Ōsaka-sayama, Osaka 589-8511
Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka 411-8777
Japan
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
Japan
The Cancer Institute Hospital of Jfcr
Koto-ku, Tokyo 135-8550
Japan
Saitama Cancer Center
Saitama, 362-0806
Japan
Medical Care & Research Sa de Cv
Mérida, 97070
Mexico
Centro de Atenciăn E Investigaciăn Clănica En Oncologăa
Mérida, 97134
Mexico
Cryptex Investigacion Clinica S.A. de C.V.
México, 06100
Mexico
Amsterdam Umc, Locatie Vumc
Amsterdam, 1081 HV
Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Netherlands
Radboudumc Nijmegen
Nijmegen, 6525 GA
Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Netherlands
Umc Utrecht
Utrecht, 3584 CW
Netherlands
SPZOZ Szpital Uniwer w Krakowie
Krakow, 30-688
Poland
Instytut MSF Sp. z o.o.
Lodz, 90-302
Poland
MRUK-MED i Spółka z ograniczoną odpowiedzialnością
Rzeszów, 35-021
Poland
Mazowiecki Szpital Wojewodzki W Siedlcach Sp Z O O
Siedlce, 08-110
Poland
Aidport Sp Z O.O.
Skorzewo, 60-185
Poland
Instituto Portuguăs de Oncologia de Lisboa Francisco Gentil, Epe
Lisbon, 1099-023
Portugal
Fundação Champalimaud
Lisbon, 1400-038
Portugal
Centro Hospitalar Universitário de Lisboa Norte
Lisbon, 1649-035
Portugal
Centro Hospitalar Universitario de Santo Antonio
Porto, 4099-001
Portugal
Inst Portude Onco do Porto
Porto, 4200-072
Portugal
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Spain
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, 08908
Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28009
Spain
Hospital Clínico San Carlos
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Universitario Virgen Macarena
Seville, 41009
Spain
China Medical University Hospital
Taichung, 404327
Taiwan
National Cheng Kung University Hospitalx
Tainan, 70403
Taiwan
National Taiwan University Hospital
Taipei, 10002
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Koo Foundation Sun Yat-Sen cancer center
Taipei, 11259
Taiwan
Tri-Service General Hospital
Taipei, 11490
Taiwan
Medipol Mega University Hospital
Bağcılar, Istanbul 34214
Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, 06010
Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, 06560
Turkey (Türkiye)
Ankara City Hospital
Ankara, 06800
Turkey (Türkiye)
Ankara University Cebeci Hospital
Ankara, 6590
Turkey (Türkiye)
Izmir Medicalpark Hospital
Izmir, 35530
Turkey (Türkiye)