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
680
18 countries
120
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; cutaneous melanoma; and neuroendocrine carcinoma (NEC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2024
Longer than P75 for phase_1
120 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
August 5, 2026
August 1, 2026
4.3 years
March 19, 2024
August 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Objective Response Rate (ORR) as Assessed by Investigator
ORR is defined as the percentage 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 60 months)
Number of Participants Reporting Dose-limiting Toxicities (DLTs) in the HCC Cohort
A 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 TEAEs and Death in the HCC Cohort
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those AEs with start or worsening after the first dose date of I-DXd and up to 40 (+7) days after the last dose date of study drug.
From date of signing the informed consent form up to 47 days after the last dose of study drug, up to approximately 60 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 60 months
Duration of Response (DoR)
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 60 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 60 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 60 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 60 months
- +7 more secondary outcomes
Study Arms (14)
Cohort 1: Endometrial Cancer (EC)
EXPERIMENTALParticipants with recurrent or metastatic EC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 milligrams per kilogram (mg/kg), intravenous (IV) infusion.
Cohort 2: Head and Neck Squamous Cell Carcinoma (HNSCC)
EXPERIMENTALParticipants with recurrent or metastatic HNSCC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
Cohort 3: Pancreatic Ductal Adenocarcinoma (PDAC)
EXPERIMENTALParticipants with recurrent or metastatic PDAC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
Cohort 4: Colorectal Cancer (CRC)
EXPERIMENTALParticipants with recurrent or metastatic CRC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
Cohort 5: Hepatocellular Carcinoma (HCC)
EXPERIMENTALParticipants with recurrent or metastatic HCC who were previously treated with 1 or more systemic therapy will receive I-DXd, at the determined dose.
Cohort 6: Adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric)
EXPERIMENTALParticipants with recurrent or metastatic Ad-Eso/GEJ/gastric who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
Cohort 7: Urothelial Carcinoma (UC)
EXPERIMENTALParticipants with recurrent or metastatic UC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
Cohort 8: Ovarian Cancer (OVC)
EXPERIMENTALParticipants with recurrent or metastatic non-squamous OVC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
Cohort 9: Cervical Cancer (CC)
EXPERIMENTALParticipants with recurrent or metastatic CC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
Cohort 10: Biliary Tract Cancer (BTC)
EXPERIMENTALParticipants with recurrent or metastatic BTC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
Cohort 11: Human epidermal growth factor 2 (HER2)-low breast cancer (BC)
EXPERIMENTALParticipants with recurrent or metastatic human epidermal growth factor 2 (HER2)-low BC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
Cohort 12: HER2 Immunohistochemistry (IHC) 0 BC
EXPERIMENTALParticipants with recurrent or metastatic HER2 IHC 0 BC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
Cohort 13: Cutaneous Melanoma
EXPERIMENTALParticipants with recurrent or metastatic cutaneous melanoma who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
Cohort 14: Neuroendocrine Carcinoma (NEC)
EXPERIMENTALParticipants with recurrent or metastatic NEC who were previously treated with 1 or more systemic therapy or for whom the standard therapy is not considered appropriate by the investigator will receive I-DXd, 12 mg/kg, IV infusion.
Interventions
Intravenous administration
Eligibility Criteria
You may qualify if:
- Participants must consent to provide a pretreatment tumor sample which has not been previously irradiated. Fresh biopsies are strongly preferred, however, if a fresh pretreatment biopsy is not feasible or the procedure is unsuccessful, an appropriate archival sample must be provided. The most recent archival sample obtained up to 5 years prior to consent is 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. For NEC participants for which the standard therapy does not exist OR for which the standard therapy is not appropriate by the investigator: presence of advanced/metastatic disease without previous regimen is acceptable.
- 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). Participants 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. Participants 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 greater than (\>)90-degree abutment or encasement of a major blood vessel.
- Participants with no prior history of Grade greater than or equal to (≥)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 participant has actionable target tumor mutation and has been previously treated with targeted therapy.
- a. No prior treatment with topoisomerase I inhibitors, such as irinotecan or topotecan.
- Pathologically or cytologically documented unresectable or metastatic CRC with microsatellite stable status (MSS).
- +41 more criteria
You may not qualify if:
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd.
- Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., T-DXd) due to treatment-related toxicities.
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
- Inadequate treatment washout period before enrollment as specified in the protocol.
- Any history of interstitial lung disease (ILD)/pneumonitis, current ILD, or suspicion of ILD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (120)
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)
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 1
- 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
August 5, 2026
Record last verified: 2026-08
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/