Trial Title:
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
Condition:
Recurrent or Metastatic Solid Tumors
Conditions: Official terms:
Recurrence
Conditions: Keywords:
Recurrent or metastatic solid tumors
Endometrial cancer
Head and neck squamous cell carcinoma
Colorectal cancer
Hepatocellular carcinoma
Adenocarcinoma of esophagus, gastroesophageal junction, and stomach
Urothelial carcinoma
Ovarian cancer
Cervical cancer
Biliary tract cancer
Human epidermal growth factor 2 (HER2)-low breast cancer
HER2 immunohistochemistry 0 breast cancer
Cutaneous melanoma
Pancreatic ductal adenocarcinoma
Ifinatamab deruxtecan (I-DXD)
DS7300a
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ifinatamab deruxtecan
Description:
Intravenous administration
Arm group label:
Cohort 10: Biliary tract cancer
Arm group label:
Cohort 11: Human epidermal growth factor 2 (HER2)-low breast cancer
Arm group label:
Cohort 12: HER2 immunohistochemistry (IHC) 0 breast cancer
Arm group label:
Cohort 13: Cutaneous melanoma
Arm group label:
Cohort 1: Endometrial Cancer
Arm group label:
Cohort 2: Head and Neck Squamous Cell Carcinoma
Arm group label:
Cohort 3: Pancreatic Ductal Adenocarcinoma
Arm group label:
Cohort 4: Colorectal Cancer
Arm group label:
Cohort 5: Hepatocellular Carcinoma
Arm group label:
Cohort 6: Adenocarcinoma of esophagus, gastroesophageal junction, and stomach
Arm group label:
Cohort 7: Urothelial carcinoma
Arm group label:
Cohort 8: Ovarian cancer
Arm group label:
Cohort 9: Cervical cancer
Other name:
I-DXd
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.
Detailed description:
This study will evaluate the efficacy and safety of I-DXd in participants with recurrent
or metastatic solid tumors previously treated with 1 or more systemic therapies for the
selected tumor indication. The study will be divided into 2 parts: Stage 1 and Stage 2.
Each cohort starts with Stage 1 and may continue to Stage 2 if sufficient safety and
efficacy data are observed.
The HCC Safety Run-In (Phase 1) will assess the safety and tolerability of I-DXd and will
assess the maximum tolerated dose (MTD). Once the MTD is established, participants with
HCC will be further treated with this dose of I-DXd.
Criteria for eligibility:
Criteria:
Participants must meet all of the following criteria to be included in the study:
Common Inclusion Criteria for All Participants
1. Sign and date the informed consent form prior to the start of any study-specific
qualification procedures.
2. 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.
3. Participants ages ≥18 years (follow local regulatory requirements if the legal age
of consent for study participation is >18 years).
4. 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.
5. Documentation of radiological disease progression on or after the previous
standard-of-care regimen in the advanced/metastatic setting.
6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Has adequate organ function as specified in the protocol within 7 days before the
start of study drug.
8. If the participant is a female of childbearing potential, she must have a negative
serum pregnancy test during Screening (within 3 days prior to enrollment). Male and
female participants of reproductive/childbearing potential must agree to use a
highly effective form of contraception or avoid intercourse during and upon
completion of the study and for at least 7 months for females and 4 months for males
after the last dose of study drug.
9. Male participants must not freeze or donate sperm starting at enrollment and
throughout the study period and for at least 4 months after the final study drug
administration.
10. Female participants must not donate, or retrieve for their own use, ova from the
time of enrollment, throughout the Study Treatment Period, and for at least 7 months
after the final study drug administration.
Additional Inclusion Criteria for EC Participants
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), 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
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, 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
Additional Inclusion Criteria for CRC Participants
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.
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.
Additional Inclusion Criteria for HCC Participants
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.
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.
Additional Inclusion Criteria for Ad-eso/GEJ/Gastric Participants
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.
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]), the subject must
have been previously treated with a HER2.
Additional Inclusion Criteria for UC Participants
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, whether administered in combination or sequentially to another anticancer
treatment, with a maximum of 3 prior therapy lines.
1. At least 1 line of therapy should contain one of the following treatment
modalities: chemotherapy or enfortumab vedotin.
2. Perioperative systemic therapies will be counted as 1 line of therapy.
3. To meet inclusion criteria requirement of prior ICI-containing therapy, use in
the perioperative or metastatic setting will suffice.
4. Fibroblast growth factor receptor (FGFR)-inhibitor treatment is allowed for
subjects who are eligible.
5. The same regimen administered twice in different disease settings will be
counted as 1 line of prior therapy.
Additional Inclusion Criteria for CC Participants
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.
2. Participants may receive prior anti-programmed death 1/programmed death-ligand 1
treatment and/or tisotumab vedotin if those are standard of care in the country.
Additional Inclusion Criteria for OVC Participants
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.
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. Participants who have received prior treatment with Folate receptor (FR)α antibody
drug conjugate (ADC) are allowed.
Additional Inclusion Criteria for BTC Participants
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.)
Additional Inclusion Criteria for HER2-Low BC Participants
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.
Additional Inclusion Criteria for HER2 IHC 0 BC Participants
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.
Additional Inclusion Criteria for Cutaneous (Acral and Non-acral) Melanoma Subjects
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
participant had proto-oncogene B-raf (BRAF)-mutated melanoma, they must have had
disease progression on BRAF/MEK inhibitor 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 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.
5. Any of the following conditions within the past 6 months: cerebrovascular accident,
transient ischemic attack, or another arterial thromboembolic event.
6. Clinically significant corneal disease.
7. Uncontrolled or significant cardiovascular disease.
8. History of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required
corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot
be ruled out by imaging at Screening.
9. Clinically severe pulmonary compromise resulting from intercurrent pulmonary
illnesses, including, but not limited to, any underlying pulmonary disorder (eg,
pulmonary emboli within 3 months of the study enrollment, severe asthma, severe
chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural
effusion, etc) and any autoimmune, connective tissue, or inflammatory disorders with
potential pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome,
sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen.
10. Participants who require chronic steroid treatment at enrollment (dose of 10 mg
daily or more prednisone equivalent), except for low-dose inhaled steroids (for
asthma/COPD) or topical steroids (for mild skin conditions), or intra-articular
steroid injections.
11. History of malignancy within the 3 years prior to enrollment, except adequately
resected nonmelanoma skin cancer, curatively treated in situ disease, superficial
gastrointestinal tract tumors, and non-muscle invasive bladder cancer curatively
resected by endoscopic surgery.
12. History of allogeneic bone marrow, stem cell, or solid organ transplant.
13. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other
than alopecia) not yet resolved to NCI-CTCAE v5.0 Grade ≤1 or baseline.
14. History of hypersensitivity to the drug substances, inactive ingredients in the drug
product, or severe hypersensitivity reactions to other mAbs.
15. Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
16. Known human immunodeficiency virus (HIV) infection that is not well controlled.
17. Has active or uncontrolled hepatitis B or C infection.
18. Has an active, known, or suspected autoimmune disease.
19. Any evidence of severe or uncontrolled systemic diseases (including active bleeding
diatheses, psychiatric illness/social situations, and substance abuse) or other
factors that, in the investigator's opinion, make it undesirable for the subject to
participate in the study or would jeopardize compliance with the protocol.
20. Has received a live vaccine within 30 days prior to the first dose of study drug.
21. Is pregnant, breastfeeding, or planning to become pregnant.
22. Has prior or ongoing clinically relevant illness, medical condition, surgical
history, physical finding, or laboratory abnormality that, in the investigator's
opinion, could affect the safety of the participant; alter the absorption,
distribution, metabolism, or excretion of the study drug; or confound the assessment
of study results
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Los Angeles Cancer Network
Address:
City:
Los Angeles
Zip:
90017
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Valkyrie Clinical Trials
Address:
City:
Los Angeles
Zip:
90067
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Pih Health Hematology Medical Oncology
Address:
City:
Whittier
Zip:
90602
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Orchard Healthcare Research Inc.
Address:
City:
Skokie
Zip:
60077
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Regents of the University of Minnesota
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
New York University Medical Center Prime
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Icahn School of Medicine At Mount Sinai Prime
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Clinical Research Alliance
Address:
City:
Westbury
Zip:
11590
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Tn Gynecologic Oncology Group, Llc
Address:
City:
Chattanooga
Zip:
37403
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
The West Clinic
Address:
City:
Germantown
Zip:
38138
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
University of Utah Hospitals & Clinics
Address:
City:
Salt Lake City
Zip:
84108
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Wenatchee Hospitals and Clinics
Address:
City:
Wenatchee
Zip:
98801
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Aleman
Address:
City:
Buenos Aires
Zip:
C1118AAT
Country:
Argentina
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Sirio Libanes
Address:
City:
Caba
Zip:
C1419GEP
Country:
Argentina
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
DIABAID
Address:
City:
Ciudad Autonoma de Buenos Aires
Zip:
C1061ABD
Country:
Argentina
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Centro de Investigaciones Medicas Mar Del Plata
Address:
City:
Mar del Plata
Zip:
7600
Country:
Argentina
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
St Vincent'S Hospital Sydney
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Genesiscare North Shore (Oncology)
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
St John of God Subiaco Hospital
Address:
City:
Subiaco
Zip:
6008
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Princess Alexandra Hospital
Address:
City:
Woolloongabba
Zip:
4102
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Cliniques Universitaires Saint-Luc
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Grand Hăpital de Charleroi
Address:
City:
Charleroi
Zip:
6000
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Universitair Ziekenhuis Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Uz Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Chu de Liăge
Address:
City:
Liege
Zip:
4000
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital de Căncer de Barretos - Fundaăăo Pio Xii
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina
Address:
City:
FlorianĂłpolis
Zip:
88034-000
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Fundaã§Ã£O Doutor Amaral Carvalho
Address:
City:
Jaú
Zip:
17210-120
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital de Clănicas de Porto Alegre
Address:
City:
Porto Alegre
Zip:
90035-903
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital São Lucas Da Pucrs
Address:
City:
Porto Alegre
Zip:
90610000
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Biocenter
Address:
City:
Concepcion
Zip:
4070196
Country:
Chile
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Ic La Serena Research
Address:
City:
La Serena
Zip:
1720430
Country:
Chile
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Clinica Redsalud Vitacura
Address:
City:
Santiago
Zip:
7650027
Country:
Chile
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Centro Del Cancer UC
Address:
City:
Santiago
Zip:
8320000
Country:
Chile
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
James Lind Centro de Investigacion Del Cancer
Address:
City:
Temuco
Zip:
4800827
Country:
Chile
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Chu Besançon - Hôpital Jean Minjoz
Address:
City:
Besançon
Zip:
25030
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Centre Georges Franăois Leclerc
Address:
City:
Dijon cedex
Zip:
21079
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Institut Régional Du Cancer de Montpellier
Address:
City:
Montpellier
Zip:
34298
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Institut Curie - Site de Paris
Address:
City:
Paris Cedex 05
Zip:
75005
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Ico - Site René Gauducheau
Address:
City:
Saint Herblain
Zip:
44800
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Institut Claudius Regaud
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Charită - Campus Charită Mitte
Address:
City:
Berlin
Zip:
10117
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Vivantes Klinikum Neukoelln
Address:
City:
Berlin
Zip:
12351
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
Address:
City:
Dresden
Zip:
01067
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Universitaetsklinikum Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Slk-Kliniken Heilbronn Gmbh
Address:
City:
Heilbronn
Zip:
74078
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Universitaetsklinikum Leipzig Aoer
Address:
City:
Leipzig
Zip:
04103
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz
Address:
City:
Mainz
Zip:
55131
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Universitaetsklinikum Muenster
Address:
City:
Muenster
Zip:
48149
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Cork University Hospital
Address:
City:
Cork
Zip:
T12DC4A
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
START Dublin, Mater Misericordiae University Hospital
Address:
City:
Dublin
Zip:
D07 R2WY
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Tallaght Hospital
Address:
City:
Dublin
Zip:
D24 NR0A
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
St Vincent'S University Hospital
Address:
City:
Dublin
Zip:
DUBLIN 4
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
University Hospital Galway
Address:
City:
Galway
Zip:
H91YR71
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Fondazione Del Piemonte Per L'Oncologia Irccs Candiolo
Address:
City:
Candiolo
Zip:
10060
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Fondazione Irccs Istituto Nazionale Dei Tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Address:
City:
Milano
Zip:
20162
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Istituto Nazionale Tumori Fondazione G. Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Address:
City:
Rome
Zip:
00138
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Istituto Clinico Humanitas
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Saitama Cancer Center
Address:
City:
Kitaadachi
Zip:
362-0806
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
The Cancer Institute Hospital of Jfcr
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
National Hospital Organization Shikoku Cancer Center
Address:
City:
Matsuyama
Zip:
791-0280
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Aichi Cancer Center Hospital
Address:
City:
Nagoya
Zip:
464-0021
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Kindai University Hospital
Address:
City:
Osaka-Sayama
Zip:
589-8511
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Medical Care & Research Sa de Cv
Address:
City:
Merida
Zip:
97070
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Centro de Atenciăn E Investigaciăn Clănica En Oncologăa
Address:
City:
Merida
Zip:
97134
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Cryptex Investigacion Clinica S.A. de C.V.
Address:
City:
Mexico
Zip:
06100
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Amsterdam Umc, Locatie Vumc
Address:
City:
Amsterdam
Zip:
1081 HV
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Radboudumc
Address:
City:
Nijmegen
Zip:
6525 GA
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Erasmus MC
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Erasmus Medisch Centrum
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Umc Utrecht
Address:
City:
Utrecht
Zip:
3508 GA
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Mruk-Med I Spăĺka Z Ograniczonä Odpowiedzialnoĺciä
Address:
City:
RzeszĂłw
Zip:
35-021
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Mazowiecki Szpital Wojewodzki W Siedlcach Sp Z O O
Address:
City:
Siedlce
Zip:
08-110
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Aidport Sp Z O.O.
Address:
City:
Skorzewo
Zip:
60-185
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Instituto Portuguăs de Oncologia de Lisboa Francisco Gentil, Epe
Address:
City:
Lisboa
Zip:
1099-023
Country:
Portugal
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Fundação Champalimaud
Address:
City:
Lisboa
Zip:
1400-038
Country:
Portugal
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Santa Maria
Address:
City:
Lisbon
Zip:
1649-028
Country:
Portugal
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Centro Hospitalar Universitario de Santo Antonio
Address:
City:
Porto
Zip:
4099-001
Country:
Portugal
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Instituto Português de Oncologia Do Porto Francisco Gentil, Epe
Address:
City:
Porto
Zip:
4200-072
Country:
Portugal
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Universitari Vall D'Hebron
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Ico L'Hospitalet - Hospital Duran I Reynals
Address:
City:
L'Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital General Universitario Gregorio Marañon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Universitario Clinico San Carlos
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hospital Universitario Virgen Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Zip:
404327
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
National Cheng Kung University Hospitalx
Address:
City:
Tainan
Zip:
70403
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Tri-Service General Hospital
Address:
City:
Taipei
Zip:
11490
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Gulhane Training and Research Hospital
Address:
City:
Ankara
Zip:
06010
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Gazi University Medical Faculty
Address:
City:
Ankara
Zip:
06500
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Ankara University Cebeci Hospital
Address:
City:
Ankara
Zip:
6590
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Ankara City Hospital
Address:
City:
Ankara
Zip:
6800
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Medipol University Medical Faculty
Address:
City:
Istanbul
Zip:
34214
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Izmir Medicalpark Hospital
Address:
City:
Izmir
Zip:
35530
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Principal Investigator
Start date:
April 10, 2024
Completion date:
July 25, 2028
Lead sponsor:
Agency:
Daiichi Sankyo
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Daiichi Sankyo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06330064
