Recurrent or Metastatic Solid TumorsPhase 1/2NCT06330064
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 1/2 study testing Ifinatamab deruxtecan in people with Recurrent or Metastatic Solid Tumors, run by Daiichi Sankyo at 120 sites in 18 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent or Metastatic Solid Tumors
- What is being tested?
- Ifinatamab deruxtecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 120 sitesin 18 countries
- Study dates
- 10 Apr 2024to 25 Jul 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
120 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
(Asia) Daiichi Sankyo Contact for Clinical Trial Information contact
120 sites in 18 countries
United States18 sites, 17 recruiting
- Recruiting
Texas Oncology - West Texas
Amarillo, Texas, 79124
- Recruiting
Erlanger Health, Inc
Chattanooga, Tennessee, 37403
Principal Investigator
- Recruiting
Texas Oncology, P.A.
Dallas, Texas, 75246
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Principal Investigator
- Recruiting
The West Clinic
Germantown, Tennessee, 38138
Principal Investigator
- Active, not recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
- Recruiting
Los Angeles Cancer Network
Los Angeles, California, 91204
Principal Investigator
- Recruiting
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55114
Principal Investigator
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
NYU Langone Health
New York, New York, 10016
Principal Investigator
- Recruiting
Icahn School of Medicine At Mount Sinai Prime
New York, New York, 10029
Principal Investigator
- Recruiting
Texas Oncology Gulf Coast
Pearland, Texas, 77584
- Recruiting
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
Principal Investigator
- Recruiting
Orchard Healthcare Research Inc
Skokie, Illinois, 60077
Principal Investigator
- Recruiting
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801
Principal Investigator
- Recruiting
Clinical Research Alliance, Inc
Westbury, New York, 11590
Principal Investigator
- Recruiting
White Plains Hospital
White Plains, New York, 10601
Principal Investigator
- Recruiting
Pih Health Hematology Medical Oncology
Whittier, California, 90602
Principal Investigator
France11 sites, 10 recruiting
- Active, not recruiting
Chu Besançon - Hôpital Jean Minjoz
Besançon, 25000
- Recruiting
Hopital Saint Andre
Bordeaux, Gironde, 33075
Principal Investigator
- Recruiting
Institut Bergonié
Bordeaux, Gironde, 33076
Principal Investigator
- Recruiting
Centre Georges François Leclerc
Dijon, Cote dÝOr, 21000
Principal Investigator
- Recruiting
Centre Léon Bérard
Lyon, Rhone, 69008
Principal Investigator
- Recruiting
Institut Régional Du Cancer de Montpellier
Montpellier, Herault, 34298
Principal Investigator
- Recruiting
Institut Curie - Site de Paris
Paris, Paris, 75005
Principal Investigator
- Recruiting
CRLCC Eugene Marquis
Rennes, Ille Et Vilaine, 35042
Principal Investigator
- Recruiting
Ico - Site René Gauducheau
Saint-Herblain, Loire Atlantique, 44800
Principal Investigator
- Not yet recruiting
Institut Claudius Regaud
Toulouse, 31059
Principal Investigator
- Recruiting
GustaveRoussy DptPharmacie
Villejuif, Val De Marne, 94805
Principal Investigator
Germany8 sites, 8 recruiting
- Recruiting
Vivantes Klinikum Neukoelln
Berlin, 12351
Principal Investigator
- Recruiting
Charită - Campus Charită Mitte
Berlin, 13353
Principal Investigator
- Recruiting
Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
Dresden, Saxony, 01067
Principal Investigator
- Recruiting
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Principal Investigator
- Recruiting
Slk-Kliniken Heilbronn Gmbh
Heilbronn, Baden-Wurttemberg, 74078
Principal Investigator
- Recruiting
Universitäres Krebszentrum Leipzig UCCL, UKL AöR
Leipzig, Saxony, 04103
Principal Investigator
- Recruiting
Univ der Johannes GutenbergU
Mainz, Rhineland-Palatinate, 55131
Principal Investigator
- Recruiting
Universitätsklinikum Münster, Medizinische Klinik A
Münster, North Rhine-Westphalia, 48149
Principal Investigator
Japan8 sites, 8 recruiting
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Principal Investigator
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Principal Investigator
- Recruiting
The Cancer Institute Hospital of Jfcr
Koto-ku, Tokyo, 135-8550
Principal Investigator
- Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
Principal Investigator
- Recruiting
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777
Principal Investigator
- Recruiting
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
Principal Investigator
- Recruiting
Kindai University Hospital
Ōsaka-sayama, Osaka, 589-8511
Principal Investigator
- Recruiting
Saitama Cancer Center
Saitama, 362-0806
Principal Investigator
Spain8 sites, 8 recruiting
- Recruiting
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Principal Investigator
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Principal Investigator
- Recruiting
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, 08908
Principal Investigator
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28009
Principal Investigator
- Recruiting
Hospital Clínico San Carlos
Madrid, 28040
Principal Investigator
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Principal Investigator
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Principal Investigator
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Principal Investigator
Argentina6 sites, 5 recruiting
- Recruiting
Hospital Aleman
Buenos Aires, Ciudad Autonoma Buenos Aires, C1118AAT
Principal Investigator
- Not yet recruiting
DIABAID
Buenos Aires, C1061ABD
Principal Investigator
- Recruiting
Hospital Sirio Libanes
Caba, Ciudad Autonoma Buenos Aires, C1419GEP
Principal Investigator
- Active, not recruiting
Centro Médico Austral
Ciudad Autonoma Buenos Aires, 1019
- Recruiting
Centro de Investigaciones Medicas y Desarrollo LC SRL LC Investigacion
Ciudad Autonoma Buenos Aires, C1113AAE
Principal Investigator
- Recruiting
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, Buenos Aires, B7600FYK
Principal Investigator
Italy6 sites, 6 recruiting
- Recruiting
Fondazione Del Piemonte Per L'Oncologia Irccs Candiolo
Candiolo, 10060
Principal Investigator
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Principal Investigator
- Recruiting
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, 20162
Principal Investigator
- Recruiting
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, 80131
Principal Investigator
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
Principal Investigator
- Recruiting
Istituto Clinico Humanitas
Rozzano, 20089
Principal Investigator
Taiwan6 sites, 6 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404327
Principal Investigator
- Recruiting
National Cheng Kung University Hospitalx
Tainan, 70403
Principal Investigator
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Principal Investigator
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Principal Investigator
- Recruiting
Koo Foundation Sun Yat-Sen cancer center
Taipei, 11259
Principal Investigator
- Recruiting
Tri-Service General Hospital
Taipei, 11490
Principal Investigator
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
Gulhane Training and Research Hospital
Ankara, 06010
Principal Investigator
- Recruiting
Gazi University Medical Faculty
Ankara, 06560
Principal Investigator
- Recruiting
Ankara City Hospital
Ankara, 06800
Principal Investigator
- Not yet recruiting
Ankara University Cebeci Hospital
Ankara, 6590
Principal Investigator
- Recruiting
Medipol Mega University Hospital
Bağcılar, Istanbul, 34214
Principal Investigator
- Not yet recruiting
Izmir Medicalpark Hospital
Izmir, 35530
Principal Investigator
Australia5 sites, 5 recruiting
- Recruiting
Blacktown Hospital
Blacktown, New South Wales, NSW 2148
Principal Investigator
- Recruiting
St Vincent'S Hospital Sydney
Mount Kuring-Gai, New South Wales, 2080
Principal Investigator
- Recruiting
Genesiscare North Shore Oncology
St Leonards, New South Wales, 2065
Principal Investigator
- Recruiting
St John of God Subiaco Hospital
Subiaco, Western Australia, 6008
Principal Investigator
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Principal Investigator
Belgium5 sites, 5 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Principal Investigator
- Recruiting
Grand Hospital de Charleroi
Charleroi, 6000
Principal Investigator
- Not yet recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Principal Investigator
- Recruiting
Uz Leuven
Leuven, 3000
Principal Investigator
- Not yet recruiting
Chu de Liăge
Liège, 4000
Principal Investigator
Brazil5 sites, 5 recruiting
- Recruiting
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos, São Paulo, 14784-400
Principal Investigator
- Recruiting
Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina
Florianópolis, Santa Catarina, 88034-000
Principal Investigator
- Recruiting
Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho
Jaú, São Paulo, 17210-120
Principal Investigator
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Principal Investigator
- Recruiting
Hospital São Lucas Da Pucrs
Porto Alegre, Rio Grande do Sul, 90610-000
Principal Investigator
Chile5 sites, 5 recruiting
- Recruiting
Biocenter
Concepción, Biobio, 4030000
Principal Investigator
- Not yet recruiting
Ic La Serena Research
La Serena, 1720430
Principal Investigator
- Recruiting
Centro Del Cancer UC
Santiago, Santiago Metropolitan, 8320000
Principal Investigator
- Recruiting
Clinica Redsalud Vitacura
Santiago, Santiago Metropolitan, 8320000
Principal Investigator
- Not yet recruiting
James Lind Centro de Investigacion Del Cancer
Temuco, 4800827
Principal Investigator
Ireland5 sites, 5 recruiting
- Not yet recruiting
Cork University Hospital
Cork, T12DC4A
Principal Investigator
- Recruiting
St Vincent'S University Hospital
Dublin, Dublin, D04 T6F4
Principal Investigator
- Recruiting
Mater Misericordiae University Hospital
Dublin, D07 R2WY
Principal Investigator
- Recruiting
Tallaght University Hospital
Dublin, D24 NR0A
Principal Investigator
- Not yet recruiting
University Hospital Galway
Galway, H91YR71
Principal Investigator
Netherlands5 sites, 5 recruiting
- Recruiting
Amsterdam Umc, Locatie Vumc
Amsterdam, 1081 HV
Principal Investigator
- Recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Principal Investigator
- Recruiting
Radboudumc Nijmegen
Nijmegen, 6525 GA
Principal Investigator
- Recruiting
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Principal Investigator
- Recruiting
Umc Utrecht
Utrecht, 3584 CW
Principal Investigator
Poland5 sites, 5 recruiting
- Recruiting
SPZOZ Szpital Uniwer w Krakowie
Krakow, 30-688
Principal Investigator
- Recruiting
Instytut MSF Sp. z o.o.
Lodz, 90-302
Principal Investigator
- Recruiting
MRUK-MED i Spółka z ograniczoną odpowiedzialnością
Rzeszów, 35-021
Principal Investigator
- Recruiting
Mazowiecki Szpital Wojewodzki W Siedlcach Sp Z O O
Siedlce, 08-110
Principal Investigator
- Recruiting
Aidport Sp Z O.O.
Skorzewo, 60-185
Principal Investigator
Portugal5 sites, 5 recruiting
- Recruiting
Instituto Portuguăs de Oncologia de Lisboa Francisco Gentil, Epe
Lisbon, 1099-023
Principal Investigator
- Recruiting
Fundação Champalimaud
Lisbon, 1400-038
Principal Investigator
- Recruiting
Centro Hospitalar Universitário de Lisboa Norte
Lisbon, 1649-035
Principal Investigator
- Recruiting
Centro Hospitalar Universitario de Santo Antonio
Porto, 4099-001
Principal Investigator
- Recruiting
Inst Portude Onco do Porto
Porto, 4200-072
Principal Investigator
Mexico3 sites
- Active, not recruiting
Medical Care & Research Sa de Cv
Mérida, 97070
- Active, not recruiting
Centro de Atenciăn E Investigaciăn Clănica En Oncologăa
Mérida, 97134
- Active, not recruiting
Cryptex Investigacion Clinica S.A. de C.V.
México, 06100
About this study
Official title: 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)
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).
Read the detailed description
This study will evaluate the efficacy and safety of I-DXd in participants with recurrent or metastatic solid tumors. The study will be divided into 3 parts: Stage 1, Stage 2 and an optional Stage 3. Each cohort starts with Stage 1 and may continue to Stage 2 if sufficient safety and efficacy data are observed. The EC cohort may proceed to an optional Stage 3 expansion based on the totality of available data.
The HCC Safety Run-In (Phase 1) will assess the safety and tolerability of I-DXd in participants with HCC.
- Conditions
- Recurrent or Metastatic Solid Tumors
- Being tested
- Ifinatamab deruxtecan
- 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, Neuroendocrine Carcinoma (NEC)
- Medical subject headings
- Recurrence, Endometrial Neoplasms, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms, Carcinoma, Hepatocellular, Adenocarcinoma Of Esophagus, Carcinoma, Transitional Cell, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ifinatamab deruxtecanDrug
Also called I-DXd
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Endometrial Cancer (EC) | Experimental | Participants 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. Receives: Drug: Ifinatamab deruxtecan |
| Cohort 2: Head and Neck Squamous Cell Carcinoma (HNSCC) | Experimental | Participants with recurrent or metastatic HNSCC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion. Receives: Drug: Ifinatamab deruxtecan |
| Cohort 3: Pancreatic Ductal Adenocarcinoma (PDAC) | Experimental | Participants with recurrent or metastatic PDAC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion. Receives: Drug: Ifinatamab deruxtecan |
| Cohort 4: Colorectal Cancer (CRC) | Experimental | Participants with recurrent or metastatic CRC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion. Receives: Drug: Ifinatamab deruxtecan |
| Cohort 5: Hepatocellular Carcinoma (HCC) | Experimental | Participants with recurrent or metastatic HCC who were previously treated with 1 or more systemic therapy will receive I-DXd, at the determined dose. Receives: Drug: Ifinatamab deruxtecan |
| Cohort 6: Adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric) | Experimental | Participants 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. Receives: Drug: Ifinatamab deruxtecan |
| Cohort 7: Urothelial Carcinoma (UC) | Experimental | Participants with recurrent or metastatic UC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion. Receives: Drug: Ifinatamab deruxtecan |
| Cohort 8: Ovarian Cancer (OVC) | Experimental | Participants 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. Receives: Drug: Ifinatamab deruxtecan |
| Cohort 9: Cervical Cancer (CC) | Experimental | Participants with recurrent or metastatic CC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion. Receives: Drug: Ifinatamab deruxtecan |
| Cohort 10: Biliary Tract Cancer (BTC) | Experimental | Participants with recurrent or metastatic BTC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion. Receives: Drug: Ifinatamab deruxtecan |
| Cohort 11: Human epidermal growth factor 2 (HER2)-low breast cancer (BC) | Experimental | Participants 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. Receives: Drug: Ifinatamab deruxtecan |
| Cohort 12: HER2 Immunohistochemistry (IHC) 0 BC | Experimental | Participants 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. Receives: Drug: Ifinatamab deruxtecan |
| Cohort 13: Cutaneous Melanoma | Experimental | Participants 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. Receives: Drug: Ifinatamab deruxtecan |
| Cohort 14: Neuroendocrine Carcinoma (NEC) | Experimental | Participants 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. Receives: Drug: Ifinatamab deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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. A serious AE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, or may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes noted. AESIs will also be assessed. AEs will be coded using MedDRA and will be graded using NCI-CTCAE v5.0.
Measured: 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)
DoR is defined as the time from the date of first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first, as assessed by the Investigator per RECIST v1.1, respectively. CR is defined as a disappearance of all target and non-target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: 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)
PFS is defined as the time interval from the date of the first dose of study drug to the date of disease progression as assessed by the investigator per RECIST v1.1 or death from any cause.
Measured: 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)
DCR is defined as the percentage of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD) as assessed by the Investigator per RECIST v1.1, respectively. CR is defined as a disappearance of all target and non-target lesions, PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as at least a 20% increase in the sum of diameters of target lesions.
Measured: 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)
OS is defined as the time interval from the date of the first dose of study drug to the date of death from any cause.
Measured: From the date of the first dose of drug up to the date of death due to any cause, up to approximately 60 months
Pharmacokinetic Parameter Maximum Concentration (CMax) for I DXd, total anti-B7-H3 antibody, and DXd
Plasma pharmacokinetic parameters will be estimated using noncompartmental methods.
Measured: Cycles1 & 3 Day1:pre-dose,end of infusion(EOI),post-dose at 3 hours(hr),6 hr;24 hr,168 hr;336 hr;504 hr; Cycles 2, 4, and 5 Day 1:pre-dose and EOI;Cycle 7 and every 2 cycles thereafter up to end of study(EOS)(60 months):pre-dose(every cycle is 21 days)]
Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration (TMax) for I DXd, total anti-B7-H3 antibody, and DXd
Plasma pharmacokinetic parameters will be estimated using noncompartmental methods.
Measured: Cycles 1 and 3 Day 1: pre-dose, EOI, 3 hr, 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: pre-dose and EOI; Cycle 7 and every 2 cycles thereafter up to EOS (60 months): pre-dose (every cycle is 21 days)]
Pharmacokinetic Parameter Half-life (t1/2) for I DXd, total anti-B7-H3 antibody, and DXd
Plasma pharmacokinetic parameters will be estimated using noncompartmental methods.
Measured: Cycles 1 and 3 Day 1: pre-dose, EOI, 3 hr, 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: pre-dose and EOI; Cycle 7 and every 2 cycles thereafter up to EOS (60 months): pre-dose (every cycle is 21 days)]
Pharmacokinetic Parameter Minimum Concentration (Ctrough) for I DXd, total anti-B7-H3 antibody, and DXd
Plasma pharmacokinetic parameters will be estimated using noncompartmental methods.
Measured: Cycles 1 and 3 Day 1: pre-dose, EOI, 3 hr, 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: pre-dose and EOI; Cycle 7 and every 2 cycles thereafter up to EOS (60 months): pre-dose (every cycle is 21 days)]
Pharmacokinetic Parameter Area Under the Curve (AUC) for I DXd, total anti-B7-H3 antibody, and DXd
Plasma pharmacokinetic parameters will be estimated using noncompartmental methods.
Measured: Cycles 1 and 3 Day 1: pre-dose, EOI, 3 hr, 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: pre-dose and EOI; Cycle 7 and every 2 cycles thereafter up to EOS (60 months): pre-dose (every cycle is 21 days)]
Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)
Anti-drug antibodies will be measured in plasma using a validated assay.
Measured: Baseline up to 60 months
Percentage of Participants Who Have Treatment-emergent ADA
Anti-drug antibodies will be measured in plasma using a validated assay.
Measured: Baseline up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start10 Apr 2024
- Primary completion25 Jul 2028 (estimated)
- Study completion25 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330064
- Sponsor's protocol ID
- DS7300-203
- Other IDs
- 2023-509632-26-00, jRCT2031240016, 2023
- Status last verified
- Aug 2026
- First submitted
- 19 Mar 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/