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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)

Status: Recruiting
Location: See all (88) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 (ICI) compared with investigator's choice of chemotherapy (ICC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
California
Providence Medical Foundation
RECRUITING
Fullerton
Michigan
Henry Ford Health System
RECRUITING
Detroit
Tennessee
Baptist Cancer Center
RECRUITING
Memphis
SCRI Oncology Partners
RECRUITING
Nashville
Texas
John Peter Smith Hospital
RECRUITING
Fort Worth
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Other Locations
Belgium
Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
Institut Jules Bordet
RECRUITING
Brussels
Antwerp University Hospital
RECRUITING
Edegem
UZ Leuven
RECRUITING
Leuven
China
Anyang Cancer Hospital
RECRUITING
Anyang
Beijing Cancer Hospital
RECRUITING
Beijing
Jilin Cancer Hospital
RECRUITING
Changchun
Changzhou Cancer Hospital
RECRUITING
Changzhou
Sichuan cancer hospital
RECRUITING
Chengdu
West China Hospital Sichuan University
RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Hefei
Jinan Central Hospital
RECRUITING
Jinan
Shandong Cancer Hospital
RECRUITING
Jinan
Affiliated Hospital of Jining Medical University
RECRUITING
Jining
Guangxi Medical University Affiliated Tumor Hospital
RECRUITING
Nanning
Liaoning Cancer Hospital and Institute
RECRUITING
Shenyang
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Xinxiang Medical University
RECRUITING
Weihui
Hubei Cancer Hospital
RECRUITING
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Zhongshan Hospital Xiamen University
RECRUITING
Xiamen
Subei Peoples Hospital
RECRUITING
Yangzhou
France
Sainte Catherine Institut du cancer Avignon en Provence
RECRUITING
Avignon
CHU Brest - Hôpital de la Cavale Blanche
RECRUITING
Brest
Institut Régional du Cancer de Montpellier
RECRUITING
Montpellier
Hôpital Européen Georges Pompidou
RECRUITING
Paris
CHU Poitiers - Hôpital la Milétrie
RECRUITING
Poitiers
Unité de recherche clinique ICANS
RECRUITING
Strasbourg
CHU Toulouse Rangueil Service dOncologie médicale
RECRUITING
Toulouse
Germany
Krankenhaus Nordwest GmbH
RECRUITING
Frankfurt Am Main
Hämatologisch Onkologische Praxis Eppendorf HOPE
RECRUITING
Hamburg
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Azienda Ospedaliera Universitaria Luigi Vanvitelli
RECRUITING
Naples
IOV - Istituto Oncologico Veneto IRCCS
RECRUITING
Padova
Fondazione Policlinico Gemelli
RECRUITING
Rome
Japan
National Cancer Center Hospital
RECRUITING
Chūōku
Hiroshima University Hospital
RECRUITING
Hiroshima
National Cancer Center Hospital East
RECRUITING
Kashiwa
Kagawa University Hospital
RECRUITING
Kita-gun
Kobe City Hospital Organization Kobe City Medical Center General Hospital
RECRUITING
Kobe
Cancer Institute Hospital of JFCR
RECRUITING
Kōtoku
Shikoku Cancer Center
RECRUITING
Matsuyama
Aichi Cancer Center
RECRUITING
Nagoya
Osaka International Cancer Institute
RECRUITING
Osaka
Kindai University Hospital
RECRUITING
Ōsaka-sayama
Saitama Cancer Center
RECRUITING
Saitama
Hokkaido University Hospital
RECRUITING
Sapporo
SHOWA Medical University Hospital
RECRUITING
Shinagawa-ku
Keio University Hospital
RECRUITING
Shinjuku-ku
The University of Osaka Hospital
RECRUITING
Suita-shi
Shizuoka Cancer Center
RECRUITING
Sunto-gun
Kanagawa Cancer Center
RECRUITING
Yokohama
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Poland
Zanamed Medical Clinic Sp z o o
RECRUITING
Lublin
Mazowiecki Szpital Wojewódzki
RECRUITING
Siedlce
Republic of Korea
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
National Cancer Center
RECRUITING
Goyang-sisouth
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun-gun
Gachon University Gil Medical Center
RECRUITING
Incheon
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Marys Hospital
RECRUITING
Seoul
Romania
Memorial Healthcare International S R L
RECRUITING
Bucharest
S.C Radiotherapy Center Cluj S.R.L
RECRUITING
Comuna Floresti
Centrul de Oncologie Sfantul Nectarie Craiova
RECRUITING
Craiova
S.C. Sigmedical Services SRL
RECRUITING
Suceava
Spain
Hospital Universitario de Burgos
RECRUITING
Burgos
Hospital General Universitario de Elche
RECRUITING
Elche
Hospital Univ Regional de Málaga Hosp Civil
RECRUITING
Málaga
Complejo Hospitalario Universitario de Orense
RECRUITING
Ourense
Hospital Universitario de Navarra
RECRUITING
Pamplona
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
NOT_YET_RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Daiichi Sankyo Contact for Clinical Trial Information
CTRinfo_us@daiichisankyo.com
9089926400
Time Frame
Start Date: 2025-03-27
Estimated Completion Date: 2029-11-01
Participants
Target number of participants: 510
Treatments
Experimental: I-DXd
Participants who are randomized to receive an intravenous infusion of I-DXd 12 mg/kg on Day 1 of every 21-day cycle (Q3W).
Active_comparator: Investigator's Choice of Chemotherapy (ICC)
Participants who are randomized to receive an intravenous infusion of investigator's choice of chemotherapy (docetaxel, paclitaxel, and irinotecan HCl).
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Daiichi Sankyo

This content was sourced from clinicaltrials.gov

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