A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
3 other identifiers
interventional
520
18 countries
119
Brief 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; and cutaneous melanoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2024
Typical duration for phase_2
119 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2024
CompletedFirst Posted
Study publicly available on registry
March 26, 2024
CompletedStudy Start
First participant enrolled
April 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 25, 2028
February 12, 2026
February 1, 2026
4.3 years
March 19, 2024
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Objective Response Rate (ORR) as Assessed by Investigator
ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
From the time of the first dose of study drug until the date of documented disease progression, death, loss to follow-up, or withdrawal by the subject, whichever occurs first up to approximately 57 months
Number of Participants Reporting Dose-limiting Toxicities in the HCC Cohort
A dose-limiting toxicity (DLT) is defined as any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes that occurs during the DLT evaluation period (from C1D1 to the end of Cycle 1 in Safety Run-in) and is Grade 3 or above, according to NCI-CTCAE version 5.0, with the exceptions as noted in the protocol.
Cycle 1 Day 1 to Cycle 1 Day 21
Number of Participants Reporting Treatment-emergent Adverse Events and Death in the HCC Cohort
A TEAE is defined as an adverse event (AE) with a start or worsening date during the on-treatment period. AEs will be coded using MedDRA and will be graded using NCI-CTCAE v5.0.
From date of signing the informed consent form up to 47 days after the last dose of study drug , up to approximately 57 months
Secondary Outcomes (12)
Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
From date of signing the informed consent form up to 47 days after the last dose of study drug , up to approximately 57 months
Duration of Response (DoR)
From the time of the first dose of study drug until the date of documented disease progression (confirmed by investigator), death, loss to follow-up, or withdrawal by the subject, whichever occurs first, up to approximately 57 months
Progression-free Survival (PFS)
From the time of the first dose of study drug until the date of documented disease progression, death, loss to follow-up, or withdrawal by the subject, whichever occurs first, up to approximately 57 months
Disease Control Rate (DCR)
From the time of the first dose of study drug until the date of documented disease progression (by investigator), death, loss to follow-up, or withdrawal by the subject, whichever occurs first, up to approximately 57 months
Overall Survival (OS)
From the date of the first dose of drug up to the date of death due to any cause, up to approximately 57 months
- +7 more secondary outcomes
Study Arms (13)
Cohort 1: Endometrial Cancer
EXPERIMENTALParticipants with recurrent or metastatic endometrial cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Cohort 2: Head and Neck Squamous Cell Carcinoma
EXPERIMENTALParticipants with recurrent or metastatic head and neck squamous carcinoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Cohort 3: Pancreatic Ductal Adenocarcinoma
EXPERIMENTALParticipants with recurrent or metastatic pancreatic ductal adenocarcinoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Cohort 4: Colorectal Cancer
EXPERIMENTALParticipants with recurrent or metastatic colorectal cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Cohort 5: Hepatocellular Carcinoma
EXPERIMENTALParticipants with recurrent or metastatic hepatocellular carcinoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd at the determined dose.
Cohort 6: Adenocarcinoma of esophagus, gastroesophageal junction, and stomach
EXPERIMENTALParticipants with recurrent or metastatic adenocarcinoma of esophagus, gastroesophageal junction, and stomach who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Cohort 7: Urothelial carcinoma
EXPERIMENTALParticipants with recurrent or metastatic urothelial carcinoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Cohort 8: Ovarian cancer
EXPERIMENTALParticipants with recurrent or metastatic non-squamous ovarian cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Cohort 9: Cervical cancer
EXPERIMENTALParticipants with recurrent or metastatic cervical cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Cohort 10: Biliary tract cancer
EXPERIMENTALParticipants with recurrent or metastatic biliary tract cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Cohort 11: Human epidermal growth factor 2 (HER2)-low breast cancer
EXPERIMENTALParticipants with recurrent or metastatic human epidermal growth factor 2 (HER2)-low breast cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Cohort 12: HER2 immunohistochemistry (IHC) 0 breast cancer
EXPERIMENTALParticipants with recurrent or metastatic HER2 immunohistochemistry (IHC) 0 breast cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Cohort 13: Cutaneous melanoma
EXPERIMENTALParticipants with recurrent or metastatic cutaneous melanoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Interventions
Intravenous administration
Eligibility Criteria
You may qualify if:
- Participant must have at least 1 lesion, not previously irradiated, amenable to core biopsy and must consent to provide a pretreatment biopsy tissue sample. An archival tumor tissue sample obtained within 6 months of consent and after progression during/after treatment with the participant's most recent cancer therapy regimen is also acceptable.
- Participants ages ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years).
- At least 1 measurable lesion on computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as assessed by the investigator.
- Documentation of radiological disease progression on or after the previous standard-of-care regimen in the advanced/metastatic setting.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Pathologically or cytologically documented EC of any histological carcinoma subtype or endometrial carcinosarcoma, irrespective of microsatellite instability or mismatch repair status.
- Relapse or progression after a platinum-containing systemic treatment and an immune checkpoint inhibitor (ICI)-containing regimen (combined or sequential). Subjects with actionable target tumor mutation should have been previously treated with targeted therapy, with a maximum of 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma. Neoadjuvant/adjuvant therapy may count as 1 line of therapy if the subject progressed within 6 months after completion of therapy.
- Pathologically or cytologically documented unresectable or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx, excluding nasopharynx, nasal cavity and paranasal sinuses, and unknown primary.
- Has disease progression after platinum-based and ICI treatment, whether administered in combination or separately. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy, with a maximum of 2 prior therapy lines for unresectable or metastatic HNSCC.
- Participants without radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrating a \>90-degree abutment or encasement of a major blood vessel.
- Participants with no prior history of Grade ≥3 bleeding as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 within 28 days prior to the start of study drug related to the current head and neck cancer may be included in the study.
- Documented p16 status for oropharyngeal cancer (historical results are acceptable if available).
- \. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma that has relapsed or progressed after 1 prior line of gemcitabine-based systemic therapy in the locally advanced/metastatic setting or after 2 lines of therapy if the subject has actionable target tumor mutation and has been previously treated with targeted therapy. No prior treatment with topoisomerase I inhibitors, such as irinotecan or topotecan.
- Pathologically or cytologically documented unresectable or metastatic CRC with microsatellite stable status.
- Relapse or progression after 1 prior line of systemic therapy including a fluoropyrimidine plus oxaliplatin with or without anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) or anti-epidermal growth factor receptor mAb therapy, as clinically indicated, or relapse or progression after 2 lines of therapy if the subject has received targeted therapy.
- +39 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (119)
Los Angeles Cancer Network
Los Angeles, California, 90017, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, 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, 55455, 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
Westbury, New York, 11590, United States
Tn Gynecologic Oncology Group, Llc
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
University of Utah Hospitals & Clinics
Salt Lake City, Utah, 84108, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Wenatchee Hospitals and Clinics
Wenatchee, Washington, 98801, United States
DIABAID
Buenos Aires, C1061ABD, Argentina
Hospital Aleman
Buenos Aires, C1118AAT, Argentina
Hospital Sirio Libanes
Caba, C1419GEP, Argentina
Centro Médico Austral
Ciudad Autonoma Buenos Aires, 1019, Argentina
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, 7600, Argentina
Genesiscare North Shore Oncology
St Leonards, New South Wales, 2065, Australia
Blacktown Hospital
Blacktown, NSW 2148, Australia
St Vincent'S Hospital Sydney
Mount Kuring-Gai, 2080, Australia
St John of God Subiaco Hospital
Subiaco, 6008, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, 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 Liă Ge
Liège, 4000, Belgium
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos, 14784-400, Brazil
Cepon - Centro de Pesquisas Oncolă"Gicas de Santa Catarina
Florianópolis, 88034-000, Brazil
Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho
Jaú, 17210-120, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Hospital São Lucas Da Pucrs
Porto Alegre, 90610-000, Brazil
Biocenter
Concepción, 4070196, Chile
Ic La Serena Research
La Serena, 1720430, Chile
Centro Del Cancer UC
Santiago, 8320000, Chile
Clinica Redsalud Vitacura
Santiago, 8320000, Chile
James Lind Centro de Investigacion Del Cancer
Temuco, 4800827, Chile
Centre Léon Bérard
Lyon, Rhone, 69008, France
Chu Besançon - Hôpital Jean Minjoz
Besançon, 25000, France
Hopital Saint Andre
Bordeaux, 33075, France
Institut Bergonié
Bordeaux, 33076, France
Centre Georges François Leclerc
Dijon, 21079, France
Institut Régional Du Cancer de Montpellier
Montpellier, 34298, France
Institut Curie - Site de Paris
Paris, 75005, France
CRLCC Eugene Marquis
Rennes, 35042, France
Ico - Site René Gauducheau
Saint-Herblain, 44800, France
Institut Claudius Regaud
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
Charită - Campus Charită Mitte
Berlin, 10117, Germany
Vivantes Klinikum Neukoelln
Berlin, 12351, Germany
Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
Dresden, 01067, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Slk-Kliniken Heilbronn Gmbh
Heilbronn, 74078, Germany
Universitäres Krebszentrum Leipzig UCCL, UKL AöR
Leipzig, 04103, Germany
Univ der Johannes GutenbergU
Mainz, 55131, Germany
Universitätsklinikum Münster, Medizinische Klinik A
Münster, 48149, Germany
Cork University Hospital
Cork, T12DC4A, Ireland
Mater Misericordiae University Hospital
Dublin, D07 R2WY, Ireland
Tallaght University Hospital
Dublin, D24 NR0A, Ireland
St Vincent'S University Hospital
Dublin, DUBLIN 4, 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
National Cancer Center Hospital
Chūōku, 104-0045, Japan
National Cancer Center Hospital East
Kashiwa, 277-8577, Japan
The Cancer Institute Hospital of Jfcr
Kōtoku, 135-8550, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280, Japan
Shizuoka Cancer Center
Nagaizumi-cho, 411-8777, Japan
Aichi Cancer Center Hospital
Nagoya, 464-0021, Japan
Kindai University Hospital
Ōsaka-sayama, 589-8511, Japan
Saitama Cancer Center
Saitama, 362-0806, Japan
Medical Care & Research Sa de Cv
Mérida, 97070, Mexico
Centro de Atenciă"N E Investigaciă"N Clă Nica En Oncologă A
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
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 Portuguă S 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 Clinic de Barcelona
Barcelona, 08036, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, 08908, Spain
Hospital Universitari Vall D'Hebron
Barcelona, 8035, 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
Gulhane Training and Research Hospital
Ankara, 06010, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, 06500, Turkey (Türkiye)
Ankara University Cebeci Hospital
Ankara, 6590, Turkey (Türkiye)
Ankara City Hospital
Ankara, 6800, Turkey (Türkiye)
Medipol Mega University Hospital
Istanbul, 34214, Turkey (Türkiye)
Izmir Medicalpark Hospital
Izmir, 35530, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
(Asia) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2024
First Posted
March 26, 2024
Study Start
April 10, 2024
Primary Completion (Estimated)
July 25, 2028
Study Completion (Estimated)
July 25, 2028
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/