Phase
Condition
N/ATreatment
Ifinatamab deruxtecan
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Participants must meet all of the following criteria to be included in the study:
Common Inclusion Criteria for All Participants
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.
Additional Inclusion Criteria for EC Participants
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.
Additional Inclusion Criteria for HNSCC Participants
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).
Additional Inclusion Criterion for PDAC Participants
- 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.
Additional Inclusion Criteria for CRC Participants
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.
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.
- No prior treatment with topoisomerase I inhibitors, such as irinotecan or topotecan.
Additional Inclusion Criteria for HCC Participants
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.
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.
Barcelona Clinic Liver Cancer (BCLC) Stage B or C.
Liver function status should be Child-Pugh (CP) Class A.
Albumin-Bilirubin (ALBI) Grade 1 within 7 days prior to the first dose of study drug.
Participants with large esophageal varices at risk of bleeding must be treated with conventional medical intervention: beta blockers or endoscopic treatment.
Additional Inclusion Criteria for Ad-eso/GEJ/Gastric Participants
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.
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.
Additional Inclusion Criteria for UC Participants
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.
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.
At least 1 line of therapy should include enfortumab vedotin in countries where enfortumab vedotin is approved and available.
Perioperative systemic therapies will be counted as 1 line of therapy.
To meet inclusion criteria requirement of prior ICI-containing therapy, use in the perioperative or metastatic setting will suffice.
Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.
The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy.
Additional Inclusion Criteria for CC Participants
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.
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.
Additional Inclusion Criteria for OVC Participants
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.
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.
Participant is not considered primary platinum refractory and has not progressed during platinum treatment or within 4 weeks after the completion of platinum treatment.
Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.
Additional Inclusion Criteria for BTC Participants
Pathologically or cytologically documented unresectable or metastatic BTC (intra- or extrahepatic cholangiocarcinoma or gallbladder carcinoma).
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.
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.)
Additional Inclusion Criteria for HER2-Low BC Participants
Pathologically or cytologically documented unresectable or metastatic BC.
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.
Progression on or after treatment with trastuzumab deruxtecan (T-DXd).
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.
Additional Inclusion Criteria for HER2 IHC 0 BC Participants
Pathologically or cytologically documented unresectable or metastatic BC.
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.
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.
Additional Inclusion Criteria for Cutaneous (Acral and Non-acral) Melanoma Subjects
Histologically or cytologically confirmed cutaneous (acral and non-acral) melanoma.
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:
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 (eg, 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.
Study Design
Study Description
Connect with a study center
Hospital Aleman
Buenos Aires, C1118AAT
ArgentinaSite Not Available
Hospital Sirio Libanes
Caba, C1419GEP
ArgentinaSite Not Available
DIABAID
Ciudad Autonoma de Buenos Aires, C1061ABD
ArgentinaSite Not Available
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, 7600
ArgentinaSite Not Available
Genesiscare North Shore Oncology
St Leonards, New South Wales 2065
AustraliaActive - Recruiting
Flinders Medical Centre (Fmc)
Bedford Park, 5042
AustraliaSite Not Available
St Vincent'S Hospital Sydney
Darlinghurst, 2010
AustraliaSite Not Available
Genesiscare North Shore (Oncology)
St Leonards, 2065
AustraliaSite Not Available
St John of God Subiaco Hospital
Subiaco, 6008
AustraliaActive - Recruiting
Princess Alexandra Hospital
Woolloongabba, 4102
AustraliaSite Not Available
Cliniques Universitaires Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
Grand Hă"Pital de Charleroi
Charleroi, 6000
BelgiumSite Not Available
Grand Hăpital de Charleroi
Charleroi, 6000
BelgiumSite Not Available
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumSite Not Available
Uz Leuven
Leuven, 3000
BelgiumSite Not Available
Chu de Liă Ge
Liege, 4000
BelgiumSite Not Available
Chu de Liăge
Liege, 4000
BelgiumSite Not Available
Hospital de Că'Ncer de Barretos - Fundaă Ă O Pio Xii
Barretos, 14784-400
BrazilSite Not Available
Hospital de Căncer de Barretos - Fundaăăo Pio Xii
Barretos, 14784-400
BrazilSite Not Available
Cepon - Centro de Pesquisas Oncolă"Gicas de Santa Catarina
FlorianĂłpolis, 88034-000
BrazilSite Not Available
Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina
FlorianĂłpolis, 88034-000
BrazilSite Not Available
Fundaã§Ã£O Doutor Amaral Carvalho
Jaú, 17210-120
BrazilSite Not Available
Hospital São Lucas Da Pucrs
Porto Alegre, 90610000
BrazilSite Not Available
Hospital de Clă Nicas de Porto Alegre
Porto Alegre, 90035-903
BrazilSite Not Available
Hospital de Clănicas de Porto Alegre
Porto Alegre, 90035-903
BrazilSite Not Available
Biocenter
Concepcion, 4070196
ChileSite Not Available
Ic La Serena Research
La Serena, 1720430
ChileSite Not Available
Centro Del Cancer UC
Santiago, 8320000
ChileSite Not Available
Clinica Redsalud Vitacura
Santiago, 7650027
ChileSite Not Available
James Lind Centro de Investigacion Del Cancer
Temuco, 4800827
ChileSite Not Available
Chu Besançon - Hôpital Jean Minjoz
Besançon, 25030
FranceSite Not Available
Centre Georges Frană Ois Leclerc
Dijon cedex, 21079
FranceSite Not Available
Centre Georges Franăois Leclerc
Dijon cedex, 21079
FranceSite Not Available
Centre Léon Bérard
Lyon, 69008
FranceSite Not Available
Institut Régional Du Cancer de Montpellier
Montpellier, 34298
FranceActive - Recruiting
Institut Curie - Site de Paris
Paris Cedex 05, 75005
FranceSite Not Available
Ico - Site René Gauducheau
Saint Herblain, 44800
FranceSite Not Available
Institut Claudius Regaud
Toulouse, 31059
FranceSite Not Available
Institut Gustave Roussy
Villejuif, 94805
FranceActive - Recruiting
Charită - Campus Charită Mitte
Berlin, 10117
GermanySite Not Available
Vivantes Klinikum Neukoelln
Berlin, 12351
GermanySite Not Available
Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
Dresden, 01067
GermanySite Not Available
Universitaetsklinikum Heidelberg
Heidelberg, 69120
GermanySite Not Available
Slk-Kliniken Heilbronn Gmbh
Heilbronn, 74078
GermanyActive - Recruiting
Universitaetsklinikum Leipzig Aoer
Leipzig, 04103
GermanySite Not Available
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz
Mainz, 55131
GermanySite Not Available
Universitaetsklinikum Muenster
Muenster, 48149
GermanySite Not Available
Mater Misericordiae University Hospital
Dublin 7, D07 AX57
Iran, Islamic Republic ofSite Not Available
Cork University Hospital
Cork, T12DC4A
IrelandSite Not Available
Mater Misericordiae University Hospital
Dublin, D07 R2WY
IrelandActive - Recruiting
START Dublin, Mater Misericordiae University Hospital
Dublin, D07 R2WY
IrelandSite Not Available
St Vincent'S University Hospital
Dublin, DUBLIN 4
IrelandSite Not Available
Tallaght Hospital
Dublin, D24 NR0A
IrelandSite Not Available
University Hospital Galway
Galway, H91YR71
IrelandSite Not Available
Fondazione Del Piemonte Per L'Oncologia Irccs Candiolo
Candiolo, 10060
ItalyActive - Recruiting
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milano, 20162
ItalySite Not Available
Fondazione Irccs Istituto Nazionale Dei Tumori
Milano, 20133
ItalySite Not Available
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, 80131
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Rome, 00138
ItalySite Not Available
Istituto Clinico Humanitas
Rozzano, 20089
ItalySite Not Available
National Cancer Center Hospital
Chuo-ku, 104-0045
JapanActive - Recruiting
National Cancer Center Hospital East
Kashiwa, 277-8577
JapanActive - Recruiting
Saitama Cancer Center
Kitaadachi, 362-0806
JapanActive - Recruiting
The Cancer Institute Hospital of Jfcr
Koto-ku, 135-8550
JapanActive - Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280
JapanActive - Recruiting
Aichi Cancer Center Hospital
Nagoya, 464-0021
JapanActive - Recruiting
Kindai University Hospital
Osaka-Sayama, 589-8511
JapanActive - Recruiting
Shizuoka Cancer Center
Sunto-gun, 411-8777
JapanActive - Recruiting
National Cancer Center
Tokyo, 104-0045
JapanSite Not Available
Chungbuk National University Hospital
Cheongju, 28644
Korea, Republic ofSite Not Available
Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic ofSite Not Available
Cha Bundang Medical Center, Cha University
Seongnam-si, 13496
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, 13620
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 5505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 3080
Korea, Republic ofSite Not Available
Centro de Atenciă"N E Investigaciă"N Clă Nica En Oncologă A
Merida, 97134
MexicoSite Not Available
Centro de Atenciăn E Investigaciăn Clănica En Oncologăa
Merida, 97134
MexicoSite Not Available
Medical Care & Research Sa de Cv
Merida, 97070
MexicoSite Not Available
Cryptex Investigacion Clinica S.A. de C.V.
Mexico, 06100
MexicoSite Not Available
Amsterdam Umc, Locatie Vumc
Amsterdam, 1081 HV
NetherlandsSite Not Available
Radboudumc
Nijmegen, 6525 GA
NetherlandsSite Not Available
Radboudumc Nijmegen
Nijmegen, 6525 GA
NetherlandsActive - Recruiting
Erasmus MC
Rotterdam, 3015 GD
NetherlandsSite Not Available
Erasmus Medisch Centrum
Rotterdam, 3015 GD
NetherlandsSite Not Available
Umc Utrecht
Utrecht, 3508 GA
NetherlandsSite Not Available
Instytut MSF Sp. z o.o.
Lodz, 90-302
PolandActive - Recruiting
MRUK-MED i Spółka z ograniczoną odpowiedzialnością
Rzeszow, 35-021
PolandActive - Recruiting
Mruk-Med I Spă"Ĺ Ka Z Ograniczonä" Odpowiedzialnoĺ Ciä"
RzeszĂłw, 35-021
PolandSite Not Available
Mruk-Med I Spăĺka Z Ograniczonä Odpowiedzialnoĺciä
RzeszĂłw, 35-021
PolandSite Not Available
Mazowiecki Szpital Wojewodzki W Siedlcach Sp Z O O
Siedlce, 08-110
PolandSite Not Available
Aidport Sp Z O.O.
Skorzewo, 60-185
PolandSite Not Available
Fundação Champalimaud
Lisboa, 1400-038
PortugalSite Not Available
Instituto Portuguă S de Oncologia de Lisboa Francisco Gentil, Epe
Lisboa, 1099-023
PortugalSite Not Available
Instituto Portuguăs de Oncologia de Lisboa Francisco Gentil, Epe
Lisboa, 1099-023
PortugalSite Not Available
Centro Hospitalar Universitário de Lisboa Norte
Lisbon, 1649-035
PortugalActive - Recruiting
Hospital Santa Maria
Lisbon, 1649-028
PortugalSite Not Available
Centro Hospitalar Universitario de Santo Antonio
Porto, 4099-001
PortugalSite Not Available
Instituto Português de Oncologia Do Porto Francisco Gentil, Epe
Porto, 4200-072
PortugalSite Not Available
Hospital Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hospital Universitari Vall D'Hebron
Barcelona, 8035
SpainSite Not Available
Ico L'Hospitalet - Hospital Duran I Reynals
L'Hospitalet de Llobregat, 08908
SpainSite Not Available
Hospital Clínico San Carlos
Madrid, 28040
SpainActive - Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Universitario Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainActive - Recruiting
Hospital Universitario Virgen Macarena
Sevilla, 41009
SpainSite Not Available
China Medical University Hospital
Taichung, 404327
TaiwanActive - Recruiting
National Cheng Kung University Hospitalx
Tainan, 70403
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 10002
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 11217
TaiwanActive - Recruiting
Tri-Service General Hospital
Taipei, 11490
TaiwanActive - Recruiting
Ankara City Hospital
Ankara, 6800
TurkeySite Not Available
Ankara University Cebeci Hospital
Ankara, 6590
TurkeySite Not Available
Gazi University Medical Faculty
Ankara, 06500
TurkeySite Not Available
Gulhane Training and Research Hospital
Ankara, 06010
TurkeySite Not Available
Medipol University Medical Faculty
Istanbul, 34214
TurkeySite Not Available
Izmir Medicalpark Hospital
Izmir, 35530
TurkeySite Not Available
Los Angeles Cancer Network
Los Angeles, California 90017
United StatesActive - Recruiting
Valkyrie Clinical Trials
Los Angeles, California 90067
United StatesSite Not Available
Pih Health Hematology Medical Oncology
Whittier, California 90602
United StatesSite Not Available
Orchard Healthcare Research Inc.
Skokie, Illinois 60077
United StatesActive - Recruiting
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Regents of the University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
Icahn School of Medicine At Mount Sinai Prime
New York, New York 10029
United StatesActive - Recruiting
New York University Medical Center Prime
New York, New York 10016
United StatesActive - Recruiting
Clinical Research Alliance
Westbury, New York 11590
United StatesActive - Recruiting
Clinical Research Alliance, Inc.
Westbury, New York 11590
United StatesActive - Recruiting
Tn Gynecologic Oncology Group, Llc
Chattanooga, Tennessee 37403
United StatesActive - Recruiting
The West Clinic
Germantown, Tennessee 38138
United StatesActive - Recruiting
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
University of Utah Hospitals & Clinics
Salt Lake City, Utah 84108
United StatesActive - Recruiting
Wenatchee Hospitals and Clinics
Wenatchee, Washington 98801
United StatesActive - Recruiting
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