A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
NCT ID: NCT06330064
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
520 participants
INTERVENTIONAL
2024-04-10
2028-07-25
Brief Summary
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Detailed Description
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The HCC Safety Run-In (Phase 1) will assess the safety and tolerability of I-DXd in participants with HCC.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Endometrial Cancer
Participants 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.
Ifinatamab deruxtecan
Intravenous administration
Cohort 2: Head and Neck Squamous Cell Carcinoma
Participants 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.
Ifinatamab deruxtecan
Intravenous administration
Cohort 3: Pancreatic Ductal Adenocarcinoma
Participants 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.
Ifinatamab deruxtecan
Intravenous administration
Cohort 4: Colorectal Cancer
Participants 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.
Ifinatamab deruxtecan
Intravenous administration
Cohort 5: Hepatocellular Carcinoma
Participants 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.
Ifinatamab deruxtecan
Intravenous administration
Cohort 6: Adenocarcinoma of esophagus, gastroesophageal junction, and stomach
Participants 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.
Ifinatamab deruxtecan
Intravenous administration
Cohort 7: Urothelial carcinoma
Participants 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.
Ifinatamab deruxtecan
Intravenous administration
Cohort 8: Ovarian cancer
Participants 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.
Ifinatamab deruxtecan
Intravenous administration
Cohort 9: Cervical cancer
Participants 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.
Ifinatamab deruxtecan
Intravenous administration
Cohort 10: Biliary tract cancer
Participants 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.
Ifinatamab deruxtecan
Intravenous administration
Cohort 11: Human epidermal growth factor 2 (HER2)-low breast cancer
Participants 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.
Ifinatamab deruxtecan
Intravenous administration
Cohort 12: HER2 immunohistochemistry (IHC) 0 breast cancer
Participants 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.
Ifinatamab deruxtecan
Intravenous administration
Cohort 13: Cutaneous melanoma
Participants 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.
Ifinatamab deruxtecan
Intravenous administration
Interventions
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Ifinatamab deruxtecan
Intravenous administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants ages ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years).
3. 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.
4. Documentation of radiological disease progression on or after the previous standard-of-care regimen in the advanced/metastatic setting.
5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
1. Pathologically or cytologically documented EC of any histological carcinoma subtype or endometrial carcinosarcoma, irrespective of microsatellite instability or mismatch repair status.
2. 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.
1. 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.
2. 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.
3. Participants without radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrating a \>90-degree abutment or encasement of a major blood vessel.
4. 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.
5. Documented p16 status for oropharyngeal cancer (historical results are acceptable if available).
Additional Inclusion Criterion for PDAC Participants
1\. 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.
1. Pathologically or cytologically documented unresectable or metastatic CRC with microsatellite stable status.
2. 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.
Note: Prior adjuvant/neoadjuvant systemic cytotoxic chemotherapy will count as 1 line of prior systemic therapy if there is documented disease progression during therapy or within 6 months of chemotherapy completion.
3. No prior treatment with topoisomerase I inhibitors, such as irinotecan or topotecan.
1. Pathologically or cytologically documented unresectable or metastatic HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) or noninvasive diagnosis of HCC as per the American Association for the Study of Liver Diseases (AASLD) criteria in subjects with a confirmed diagnosis of cirrhosis.
2. Relapse or progression after 1 prior line of an ICI-containing regimen (combination or monotherapy) in the locally advanced/metastatic setting, with a maximum of 2 prior lines. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.
3. Barcelona Clinic Liver Cancer (BCLC) Stage B or C.
4. Liver function status should be Child-Pugh (CP) Class A.
5. Albumin-Bilirubin (ALBI) Grade 1 within 7 days prior to the first dose of study drug.
6. Participants with large esophageal varices at risk of bleeding must be treated with conventional medical intervention: beta blockers or endoscopic treatment.
1. Pathologically or cytologically documented unresectable or metastatic Ad-eso/GEJ/Gastric that has relapsed or progressed after 1 prior line of systemic therapy in the locally advanced/metastatic setting. Subjects with PD-(L)1+ or MSI-H/dMMR should receive ICI treatment if ICIs are standard of care in the country, unless the subject is ineligible for ICI treatment.
2. If the participant has known history of HER2 positivity (defined by IHC 3+ or IHC 2+ and in situ hybridization \[ISH\] positive, as classified by American Society of Clinical Oncology - College of American Pathologists \[ASCO CAP\]) or actionable target, the subject must have been previously treated with a targeted therapy.
1. Pathologically or cytologically documented unresectable or metastatic UC of the bladder, renal pelvis, ureter, or urethra. Participants with histological variants are allowed if urothelial histology is predominant. Small cell/neuroendocrine tumors are not allowed even if mixed histology.
2. Relapse or progression after at least 1 prior line of ICI-containing systemic therapy, and 1 prior line of systemic chemotherapy, given in combination with other anticancer therapy or separately, with a maximum of 3 prior therapy lines.
1. At least 1 line of therapy should include enfortumab vedotin in countries where enfortumab vedotin is approved and available.
2. Perioperative systemic therapies will be counted as 1 line of therapy.
4. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.
5. The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy.
1. Histologically confirmed unresectable or metastatic CC that was previously treated with ≥1 prior line of systemic therapy in the locally advanced or metastatic setting. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.
2. Participants should receive prior anti-programmed death 1/programmed death-ligand 1 treatment and/or tisotumab vedotin if those are standard of care in the country, unless the subject is ineligible for these treatments.
1. Histologically confirmed high-grade serous OVC, high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer that was previously treated with at least 1 line of platinum-based therapy and bevacizumab unless the subject is ineligible for treatment with bevacizumab.
2. Participant is no longer considered eligible for platinum-based therapy per the investigator's opinion or has progressed less than 180 days after the last dose of platinum therapy.
3. Participant is not considered primary platinum refractory and has not progressed during platinum treatment or within 4 weeks after the completion of platinum treatment.
4. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.
1. Pathologically or cytologically documented unresectable or metastatic BTC (intra- or extrahepatic cholangiocarcinoma or gallbladder carcinoma).
2. Relapse or progression after at least 1 prior line of systemic therapy, or 2 prior lines of systemic therapy if the participant has an actionable target and has received targeted therapy.
3. Histological subtypes other than ampullary cancer, small cell cancer, lymphoma, sarcoma, neuroendocrine tumors, mixed tumor histology, and/or mucinous cystic neoplasms (Please note that the histological subtypes listed here are not allowed.)
1. Pathologically or cytologically documented unresectable or metastatic BC.
2. Low HER2 expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested), according to ASCO-CAP 2018 HER2 testing guidelines, based on most recent testing, regardless of hormonal status.
3. Progression on or after treatment with trastuzumab deruxtecan (T-DXd).
4. Relapse or progression after at least 2 and a maximum of 3 prior lines of systemic therapy. Subjects with metastatic hormone receptor (HR)+ BC who have received endocrine-based therapy and have received at least 2 and a maximum of 3 prior lines of additional systemic therapy in the metastatic setting. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.
1. Pathologically or cytologically documented unresectable or metastatic BC.
2. Negative for HER2 expression, defined as IHC 0 (ISH- or untested) according to ASCO-CAP 2018 HER2 testing guidelines, based on the most recent testing, regardless of hormonal status.
3. Relapse or progression after at least 2 and a maximum of 3 prior lines of systemic therapy. Participants with metastatic HR+ BC who have received endocrine-based therapy and have received at least 2 and a maximum of 3 prior lines of additional systemic therapy in the metastatic setting. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.
1. Histologically or cytologically confirmed cutaneous (acral and non-acral) melanoma.
2. Disease progression while on or after having received treatment with ≥1 prior line of ICI based therapy. Prior anti-PD-(L)1 therapy in the adjuvant setting may be counted as 1 line if there is recurrence within 12 weeks of the last dose. If the subject had BRAF mutated melanoma or other actionable target tumor mutation, they must have had disease progression on targeted therapy as well.
Participants who meet any of the following criteria will be disqualified from entering the study:
1. Prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd.
2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, T-DXd) due to treatment-related toxicities.
3. 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.
4. Inadequate treatment washout period before enrollment as specified in the protocol.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Locations
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Los Angeles Cancer Network
Los Angeles, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Pih Health Hematology Medical Oncology
Whittier, California, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States
NYU Langone Health
New York, New York, United States
Icahn School of Medicine At Mount Sinai Prime
New York, New York, United States
Clinical Research Alliance
Westbury, New York, United States
Tn Gynecologic Oncology Group, Llc
Chattanooga, Tennessee, United States
The West Clinic
Germantown, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology - West Texas
Amarillo, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Texas Oncology Gulf Coast
Pearland, Texas, United States
University of Utah Hospitals & Clinics
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Wenatchee Hospitals and Clinics
Wenatchee, Washington, United States
DIABAID
Buenos Aires, , Argentina
Hospital Aleman
Buenos Aires, , Argentina
Hospital Sirio Libanes
Caba, , Argentina
Centro Médico Austral
Ciudad Autonoma Buenos Aires, , Argentina
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, , Argentina
Genesiscare North Shore Oncology
St Leonards, New South Wales, Australia
Blacktown Hospital
Blacktown, , Australia
St Vincent'S Hospital Sydney
Mount Kuring-Gai, , Australia
St John of God Subiaco Hospital
Subiaco, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Grand Hospital de Charleroi
Charleroi, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Uz Leuven
Leuven, , Belgium
Chu de Liă Ge
Liège, , Belgium
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos, , Brazil
Cepon - Centro de Pesquisas Oncolă"Gicas de Santa Catarina
Florianópolis, , Brazil
Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho
Jaú, , Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, , Brazil
Hospital São Lucas Da Pucrs
Porto Alegre, , Brazil
Biocenter
Concepción, , Chile
Ic La Serena Research
La Serena, , Chile
Centro Del Cancer UC
Santiago, , Chile
Clinica Redsalud Vitacura
Santiago, , Chile
James Lind Centro de Investigacion Del Cancer
Temuco, , Chile
Centre Léon Bérard
Lyon, Rhone, France
Chu Besançon - Hôpital Jean Minjoz
Besançon, , France
Institut Bergonié
Bordeaux, , France
Centre Georges François Leclerc
Dijon, , France
Institut Régional Du Cancer de Montpellier
Montpellier, , France
Institut Curie - Site de Paris
Paris, , France
CRLCC Eugene Marquis
Rennes, , France
Ico - Site René Gauducheau
Saint-Herblain, , France
Institut Claudius Regaud
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Charită - Campus Charită Mitte
Berlin, , Germany
Vivantes Klinikum Neukoelln
Berlin, , Germany
Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
Dresden, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Slk-Kliniken Heilbronn Gmbh
Heilbronn, , Germany
Universitäres Krebszentrum Leipzig UCCL, UKL AöR
Leipzig, , Germany
Univ der Johannes GutenbergU
Mainz, , Germany
Universitätsklinikum Münster, Medizinische Klinik A
Münster, , Germany
Cork University Hospital
Cork, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
Tallaght University Hospital
Dublin, , Ireland
St Vincent'S University Hospital
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
Fondazione Del Piemonte Per L'Oncologia Irccs Candiolo
Candiolo, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
National Cancer Center Hospital
Chūōku, , Japan
National Cancer Center Hospital East
Kashiwa, , Japan
The Cancer Institute Hospital of Jfcr
Kōtoku, , Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, , Japan
Shizuoka Cancer Center
Nagaizumi-cho, , Japan
Aichi Cancer Center Hospital
Nagoya, , Japan
Kindai University Hospital
Ōsaka-sayama, , Japan
Saitama Cancer Center
Saitama, , Japan
Medical Care & Research Sa de Cv
Mérida, , Mexico
Centro de Atenciă"N E Investigaciă"N Clă Nica En Oncologă A
Mérida, , Mexico
Cryptex Investigacion Clinica S.A. de C.V.
México, , Mexico
Amsterdam Umc, Locatie Vumc
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Radboudumc Nijmegen
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Umc Utrecht
Utrecht, , Netherlands
Instytut MSF Sp. z o.o.
Lodz, , Poland
MRUK-MED i Spółka z ograniczoną odpowiedzialnością
Rzeszów, , Poland
Mazowiecki Szpital Wojewodzki W Siedlcach Sp Z O O
Siedlce, , Poland
Aidport Sp Z O.O.
Skorzewo, , Poland
Instituto Portuguă S de Oncologia de Lisboa Francisco Gentil, Epe
Lisbon, , Portugal
Fundação Champalimaud
Lisbon, , Portugal
Centro Hospitalar Universitário de Lisboa Norte
Lisbon, , Portugal
Centro Hospitalar Universitario de Santo Antonio
Porto, , Portugal
Inst Portude Onco do Porto
Porto, , Portugal
Hospital Clinic de Barcelona
Barcelona, , Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, , Spain
Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospitalx
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Koo Foundation Sun Yat-Sen cancer center
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Gulhane Training and Research Hospital
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, , Turkey (Türkiye)
Ankara University Cebeci Hospital
Ankara, , Turkey (Türkiye)
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Medipol University Medical Faculty
Istanbul, , Turkey (Türkiye)
Izmir Medicalpark Hospital
Izmir, , Turkey (Türkiye)
Countries
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Central Contacts
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(US) Daiichi Sankyo Contact for Clinical Trial Information
Role: CONTACT
Phone: 9089926400
Email: [email protected]
(Asia) Daiichi Sankyo Contact for Clinical Trial Information
Role: CONTACT
Phone: +81-3-6225-1111 (M-F 9-5 JST
Email: [email protected]
Facility Contacts
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Other Identifiers
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2023-509632-26-00
Identifier Type: OTHER
Identifier Source: secondary_id
JRCT2031240016
Identifier Type: OTHER
Identifier Source: secondary_id
DS7300-203
Identifier Type: -
Identifier Source: org_study_id