AzTrials
AzTrials

Esophageal Squamous Cell CarcinomaPhase 3NCT06644781

A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)

A Phase 3 study testing Ifinatamab deruxtecan, Docetaxel and Paclitaxel in people with Esophageal Squamous Cell Carcinoma, run by Daiichi Sankyo at 168 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-based systemic therapy and an immune checkpoint inhibitor… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Ifinatamab deruxtecan, Docetaxel and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
510 participants
Where
168 sitesin 17 countries
Study dates
27 Mar 2025to 1 Nov 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Participants must meet all of the following criteria to be eligible for randomization into the study:
  • Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
  • Has histologically or cytologically documented unresectable locally advanced or metastatic ESCC according to American Joint Committee on Cancer 8th edition staging system on ESCC.
  • Has disease progression post a platinum-based chemotherapy and an ICI treatment per global or local guidelines, with a maximum of 1 prior line of systemic therapy for unresectable advanced or metastatic ESCC.
  • The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content as defined in the Laboratory Manual.
  • Has at least 1 measurable lesion on computed tomography (CT)/magnetic resonance imaging (MRI) according to RECIST v1.1 as assessed by the investigator. Measurable lesions should not be from a previously irradiated site. If the lesion at a previously irradiated site is the only selectable target lesion, a radiological assessment showing significant progression of the irradiated lesion should be provided by the investigator.
  • Has an ECOG PS of 0 or 1 within 7 days prior to Cycle 1 Day 1.

Who cannot join

  • Participants who meet any of the following criteria will be disqualified from entering the study:
  • Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
  • Has received any topoisomerase inhibitor.
  • Has histologically or cytologically confirmed adenosquamous carcinoma subtype.
  • Is ineligible to all the chemotherapies in the comparator arm due to prior progression or intolerance.
  • Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of bleeding or fistula as assessed by the investigator.
Show all 12Show fewer
  • 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. Subjects with clinically inactive or treated brain metastases who are asymptomatic (ie, without neurologic signs or symptoms and not requiring treatment with corticosteroids or anticonvulsants) may be included in the study. Subjects must have a stable neurologic status and discontinue corticosteroid usage for at least 2 weeks prior to Screening.
  • Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event, or pulmonary embolism.
  • Has a clinically significant corneal disease.
  • Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.
  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study randomization, severe asthma, chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc), and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen.
  • Is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma/COPD), topical steroids (for mild skin conditions), or intra-articular steroid injections.

Trial locations and contacts

168 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Daiichi Sankyo Contact for Clinical Trial Information contact

9089926400

CTRinfo_us@daiichisankyo.com

168 sites in 17 countries

China30 sites, 30 recruiting

  • Anyang Cancer Hospital

    Anyang, 455000

    Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Recruiting

  • Jilin Cancer Hospital

    Changchun, 130000

    Recruiting

  • The First Hospital of Jilin University

    Changchun, 130000

    Recruiting

  • Changzhou Cancer Hospital

    Changzhou, 213001

    Recruiting

  • Sichuan cancer hospital

    Chengdu, 610041

    Recruiting

  • West China Hospital Sichuan University

    Chengdu, 610041

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, 350015

    Recruiting

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310003

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, 230088

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Hefei, 230088

    Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, 230601

    Recruiting

  • Jieyang Peoples Hospital

    Jieyang, 522000

    Recruiting

  • Jinan Central Hospital

    Jinan, 250013

    Recruiting

  • Shandong Cancer Hospital

    Jinan, 250117

    Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining, 272029

    Recruiting

  • Linyi Cancer Hospital

    Linyi, 276001

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, 471000

    Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, 530021

    Recruiting

  • Cancer Hospital of Shantou University Medical College

    Shantou, 515031

    Recruiting

  • Liaoning Cancer Hospital and Institute

    Shenyang, 110042

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 453000

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Weihui, 453100

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, 430000

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022

    Recruiting

  • Zhongshan Hospital Xiamen University

    Xiamen, 361004

    Recruiting

  • Subei Peoples Hospital

    Yangzhou, 225001

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, 450000

    Recruiting

Other trials in China

France17 sites, 17 recruiting

  • Sainte Catherine Institut du cancer Avignon en Provence

    Avignon, 84918

    Recruiting

  • CHU Brest - Hôpital de la Cavale Blanche

    Brest, 29609

    Recruiting

  • Centre Georges François Leclerc

    Dijon, 21079

    Recruiting

  • Hopital Claude Huriez - Chu Lille

    Lille, 59037

    Recruiting

  • Centre Leon Berard

    Lyon, 69008

    Recruiting

  • Institut Paoli Calmettes

    Marseille, 13273

    Recruiting

  • Institut Régional du Cancer de Montpellier

    Montpellier, 34298

    Recruiting

  • Chru De Nantes Hotel-Dieu

    Nantes, 44093

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 6189

    Recruiting

  • Hôpital Européen Georges Pompidou

    Paris, 75015

    Recruiting

  • Hăpital Saint-Antoine

    Paris, 75571

    Recruiting

  • Chu Bordeaux - Hăpital Haut-Lăvăque

    Pessac, 336600

    Recruiting

  • CHU Poitiers - Hôpital la Milétrie

    Poitiers, 86000

    Recruiting

  • Crlcc Eugene Marquis

    Rennes, 35042

    Recruiting

  • Institut Curie - Centre Renă Huguenin

    Saint-Cloud, 92210

    Recruiting

  • Institut de Cancărologie de Strasbourg Europe - Icans

    Strasbourg, 67033

    Recruiting

  • CHU Toulouse Rangueil Service dOncologie médicale

    Toulouse, 31059

    Recruiting

Other trials in France

Japan17 sites, 17 recruiting

  • National Cancer Center Hospital

    Chūōku, 104-0045

    Recruiting

  • Hiroshima University Hospital

    Hiroshima, 734-8551

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

    Recruiting

  • Kagawa University Hospital

    Kita-gun, 761-0793

    Recruiting

  • Kobe City Hospital Organization Kobe City Medical Center General Hospital

    Kobe, 650-0047

    Recruiting

  • Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550

    Recruiting

  • Nho Shikoku Cancer Center

    Matsuyama, 791-0280

    Recruiting

  • Aichi Cancer Center

    Nagoya, 464-8681

    Recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567

    Recruiting

  • Kindai University Hospital

    Ōsaka-sayama, 589-8511

    Recruiting

  • Saitama Cancer Center

    Saitama, 362-0806

    Recruiting

  • Hokkaido University Hospital

    Sapporo, 060-8648

    Recruiting

  • SHOWA Medical University Hospital

    Shinagawa-ku, 142-8666

    Recruiting

  • Keio University Hospital

    Shinjuku-ku, 160-8582

    Recruiting

  • The University of Osaka Hospital

    Suita-shi, 565-0871

    Recruiting

  • Shizuoka Cancer Center

    Sunto-gun, 411-8777

    Recruiting

  • Kanagawa Cancer Center

    Yokohama, 241-8515

    Recruiting

Other trials in Japan

United States14 sites, 14 recruiting

  • Maimonides Cancer Center

    Brooklyn, New York, 11220

    Recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • John Peter Smith Hospital

    Fort Worth, Texas, 76104

    Recruiting

  • Providence Medical Foundation

    Fullerton, California, 92835

    Recruiting

  • Penn State University Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Recruiting

  • MidAmerica Cancer Care - American Oncology Partners

    Kansas City, Missouri, 64132

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Recruiting

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

    Recruiting

  • Morristown Medical Center

    Morristown, New Jersey, 07960

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Univ of California Irvine College of Medicine

    Orange, California, 92868

    Recruiting

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Recruiting

Other trials in United States

Spain14 sites, 14 recruiting

  • Hospital del Mar

    Barcelona, 8003

    Recruiting

  • Hospital Universitari Vall dHebron

    Barcelona, 8035

    Recruiting

  • Hospital Universitario de Burgos

    Burgos, 9006

    Recruiting

  • Hospital General Universitario de Elche

    Elche, 3203

    Recruiting

  • Ico L Hospitalet - Hospital Duran I Reynals

    L'Hospitalet de Llobregat, 08908

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Univ Regional de Málaga Hosp Civil

    Málaga, 29010

    Recruiting

  • Complejo Hospitalario Universitario de Orense

    Ourense, 32005

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, 33013

    Recruiting

  • Hospital Universitario de Navarra

    Pamplona, 31008

    Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, 39012

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Recruiting

  • Hospital Universitari i Politecnic La Fé

    Valencia, 46026

    Recruiting

Other trials in Spain

Germany11 sites, 11 recruiting

  • Charité - Campus Charité Mitte

    Berlin, 10117

    Recruiting

  • Vivantes Klinikum Im Friedrichshain

    Berlin, 10249

    Recruiting

  • Universitaetsklinikum Bonn Aoer

    Bonn, 53127

    Recruiting

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307

    Recruiting

  • Krankenhaus Nordwest GmbH

    Frankfurt am Main, 60488

    Recruiting

  • Hämatologisch Onkologische Praxis Eppendorf HOPE

    Hamburg, 20249

    Recruiting

  • Asklepios Klinik Altona

    Hamburg, 22763

    Recruiting

  • Universitaetsklinikum Jena

    Jena, 07743

    Recruiting

  • Universitaetsklinikum Leipzig AoeR

    Leipzig, 04103

    Recruiting

  • Klinikum Nuernberg Nord

    Nuremberg, 90419

    Recruiting

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

    Recruiting

Other trials in Germany

Italy11 sites, 11 recruiting

  • Clinica Oncologica-AOU delle Marche second floor

    Ancona, 60100

    Recruiting

  • National Institute of Gastroenterology Saverio De Bellis Research Hospital

    Castellana Grotte, 70013

    Recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Recruiting

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli

    Naples, 80131

    Recruiting

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova, 35128

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

    Recruiting

  • Fondazione Policlinico Gemelli

    Rome, 00168

    Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

  • A.O. Pia Fondazione Cardinale G. Panico

    Tricase, 73039

    Recruiting

Other trials in Italy

United Kingdom11 sites, 11 recruiting

  • Altnagelvin Area Hospital

    Belfast, BT47 1SB

    Recruiting

  • Ninewells Hospital

    Dundee, DD1 9SY

    Recruiting

  • Barts Hospital

    London, EC1A 7BE

    Recruiting

  • University College London Hospitals

    London, NW1 2BU

    Recruiting

  • Guy s Cancer Centre Guy s Hospital

    London, SE1 9RT

    Recruiting

  • Sarah Cannon Research Institute UK

    London, W1G 6AD

    Recruiting

  • Charing Cross Hospital

    London, W2 1NY

    Recruiting

  • The Christie

    Manchester, M20 4BX

    Recruiting

  • Derriford Hospital

    Plymouth, PL6 8DH

    Recruiting

  • Royal Marsden Hospital- Fulham

    Sutton, SM25PT

    Recruiting

  • Royal Marsden Hospital

    Sutton, SM25PT

    Recruiting

Other trials in United Kingdom

South Korea10 sites, 10 recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, 700-721

    Recruiting

  • National Cancer Center

    Goyang-si, 10408

    Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, 58128

    Recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • The Catholic University of Korea, Seoul St. Marys Hospital

    Seoul, 06591

    Recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Recruiting

Other trials in South Korea

Romania7 sites, 7 recruiting

  • Memorial Healthcare International S R L

    Bucharest, 13823

    Recruiting

  • Institutul Clinic Fundeni

    Bucharest, 22328

    Recruiting

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca

    Cluj-Napoca, 400015

    Recruiting

  • S.C Radiotherapy Center Cluj S.R.L

    Comuna Floresti, 407280

    Recruiting

  • Centrul de Oncologie Sfantul Nectarie Craiova

    Craiova, 200542

    Recruiting

  • SC Centrul de Oncologie Euroclinic SRL

    Iași, 700106

    Recruiting

  • S.C. Sigmedical Services SRL

    Suceava, 720284

    Recruiting

Other trials in Romania

Belgium6 sites, 6 recruiting

  • Institut Jules Bordet

    Brussels, 1070

    Recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

    Recruiting

  • Antwerp University Hospital

    Edegem, 2650

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Recruiting

  • Chu de Liege

    Liège, 4000

    Recruiting

Other trials in Belgium

Taiwan5 sites, 5 recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

    Recruiting

  • China Medical University Hospital

    Taichung, 40447

    Not yet recruiting

  • National Cheng Kung University Hospital

    Tainan, 70403

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100225

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

Other trials in Taiwan

Netherlands4 sites, 4 recruiting

  • Netherlands Cancer Institute

    Amsterdam, 1066CX

    Recruiting

  • Amsterdam UMC - location VUmc

    Amsterdam, 1105 AZ

    Recruiting

  • Radboud University Medical Center

    Nijmegen, 6525 GA

    Recruiting

  • Erasmus MC

    Rotterdam, 3015 GD

    Recruiting

Other trials in Netherlands

Denmark3 sites, 3 recruiting

  • Aarhus University Hospital

    Arhus N, 8200

    Recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Recruiting

  • Odense University Hospital. Department of Research, Oncology

    Odense C, 5000

    Recruiting

Other trials in Denmark

Norway3 sites, 3 recruiting

  • Sørlandet Sykehus Hf Kristiansand

    Kristiansand, 4612

    Recruiting

  • Akershus Universitetssykehus Hf

    Lørenskog, 1478

    Recruiting

  • Stavanger University Hospital

    Stavanger, 4011

    Recruiting

Other trials in Norway

Poland3 sites, 3 recruiting

  • Zanamed Medical Clinic Sp z o o

    Lublin, 20-362

    Recruiting

  • Mazowiecki Szpital Wojewódzki

    Siedlce, 08-110

    Recruiting

  • Wojskowy Instytut Medyczny

    Warsaw, 04-141

    Recruiting

Other trials in Poland

Sweden2 sites, 2 recruiting

  • Sahlgrenska Sjukhuset

    Gothenburg, 41345

    Recruiting

  • Karolinska Universitetssjukhuset Solna

    Solna, 17164

    Recruiting

Other trials in Sweden

About this study

Official title: A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)

This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-based systemic therapy and an immune checkpoint inhibitor (ICI) compared with investigator's choice of chemotherapy (ICC).

Read the detailed description

The primary objective of this study is to evaluate the overall survival (OS) benefit of I-DXd compared with investigator's choice of chemotherapy (ICC).

The key secondary objectives of the study will evaluate the progression-free survival (PFS) and objective response rate (ORR) benefit of I-DXd compared with ICC.

Being tested
Ifinatamab deruxtecan, Docetaxel, Paclitaxel, Irinotecan hydrochloride (HCl)
Keywords
Esophageal squamous cell carcinoma, Ifinatamab deruxtecan (I-DXd), DS-7300a
Medical subject headings
Esophageal Squamous Cell Carcinoma

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

  • DocetaxelDrug

    Intravenous administration

  • PaclitaxelDrug

    Intravenous administration

  • Irinotecan hydrochloride (HCl)Drug

    Intravenous administration

Study groups in NCT06644781
Study groupRoleWhat they receive
I-DXdExperimentalParticipants who are randomized to receive an intravenous infusion of I-DXd 12 mg/kg on Day 1 of every 21-day cycle (Q3W).
Receives: Drug: Ifinatamab deruxtecan
Investigator's Choice of Chemotherapy (ICC)Active comparatorParticipants who are randomized to receive an intravenous infusion of investigator's choice of chemotherapy (docetaxel, paclitaxel, and irinotecan HCl).
Receives: Drug: Docetaxel; Drug: Paclitaxel; Drug: Irinotecan hydrochloride (HCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall Survival (OS) is defined as the time interval from the date of randomization to the date of death due to any cause.

    Measured: From the date of randomization to the date of death due to any cause, up to approximately 54 months

Secondary outcomes (11)

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) is defined as the time interval from the date of randomization to the first date of disease progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.

    Measured: From the date of randomization to the date of disease progression or death due to any cause, whichever occurs first, up to approximately 54 months

  2. Objective Response Rate (ORR)

    Objective response rate (ORR) is defined as the proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per RECIST v1.1.

    Measured: From the time of first dose of study drug until date of documented disease progression or death, whichever occurs first, up to approximately 54 months

  3. Duration of Response (DoR)

    Duration of response (DoR) is defined as the time from the date of first documentation of objective tumor response (CR or PR), which is subsequently confirmed by BICR assessment, to the first documentation of objective tumor progression (confirmed by BICR) or to death due to any cause, whichever occurs first.

    Measured: From the time of the first dose of study drug until the date of documented disease progression (as assessed by BICR) or death due to any cause, up to approximately 54 months

  4. Disease Control Rate (DCR)

    Disease control rate (DCR) is defined as the proportion of participants with a BOR of confirmed CR, confirmed PR, or stable disease (SD) according to RECIST v1.1 and will be determined by BICR assessment review of tumor scans.

    Measured: From the time of the first dose of study drug until the date of documented disease progression (as assessed by BICR) or death due to any cause, up to approximately 54 months

  5. Change from baseline in European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Score (EORTC QLQ-C30)

    Measured: Baseline up to 54 months

  6. Change from baseline in European Organisation for Research and Treatment of Cancer Esophageal Cancer Module Score (EORTC OES18)

    Measured: Baseline up to 54 months

  7. Incidence of Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events of Special Interest (AESIs)

    A TEAE is defined as an adverse event (AE) with a start or worsening date during the on-treatment period. A serious TEAE 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: Baseline up to 54 months

  8. Percentage of Participants Who Have Treatment-emergent ADA

    Anti-drug antibodies (ADAs) will be measured in the plasma using a validated assay.

    Measured: Baseline up to 54 months

  9. Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for I-DXd

    Plasma pharmacokinetic parameters will be assessed using noncompartmental methods.

    Measured: Cycle 1: Before infusion (BI), end of infusion (EOI), 3 hours (hr), 6hr, 24hr, 72hr, 168hr, 336hr, 504hr postdose; Cycle 2: BI and EOI; Cycle 3: BI, EOI, and 6hr postdose; Cycle 4, 5, & every 2 cycles thereafter, up to 54 mths: BI (each cycle is 21 days)

  10. Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for Total Anti-B7-H3 Antibody

    Plasma pharmacokinetic parameters will be assessed using noncompartmental methods.

    Measured: Cycle 1: Before infusion (BI), end of infusion (EOI), 3 hours (hr), 6hr, 24hr, 72hr, 168hr, 336hr, 504hr postdose; Cycle 2: BI and EOI; Cycle 3: BI, EOI, and 6hr postdose; Cycle 4, 5, & every 2 cycles thereafter, up to 49 mths: BI (each cycle is 21 days)

  11. Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for MAAA-1181a

    Plasma pharmacokinetic parameters will be assessed using noncompartmental methods.

    Measured: Cycle 1: Before infusion (BI), end of infusion (EOI), 3 hours (hr), 6hr, 24hr, 72hr, 168hr, 336hr, 504hr postdose; Cycle 2: BI and EOI; Cycle 3: BI, EOI, and 6hr postdose; Cycle 4, 5, & every 2 cycles thereafter, up to 49 mths: BI (each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2024
  2. Study start27 Mar 2025
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Nov 2029 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
510 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06644781
Sponsor's protocol ID
DS7300-202
Other IDs
2023-509630-19-00, 2023
Status last verified
Aug 2026
First submitted
10 Oct 2024
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
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/

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ifinatamab deruxtecan, Docetaxel and Paclitaxel in people with Esophageal Squamous Cell Carcinoma, run by Daiichi Sankyo at 168 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 168 sites in China, France, Japan, United States, Spain and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daiichi Sankyo Contact for Clinical Trial Information (9089926400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From the date of randomization to the date of death due to any cause, up to approximately 54 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06644781.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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