Actively Recruiting
A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Led by Daiichi Sankyo · Updated on 2026-01-12
510
Participants Needed
88
Research Sites
74 weeks
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating 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 after receiving platinum-based chemotherapy and an immune checkpoint inhibitor (ICI). The main goal is to assess whether I-DXd improves overall survival compared to an investigator's choice of chemotherapy (ICC). Secondary goals include measuring progression-free survival and objective response rate. Participants are randomly assigned to receive either I-DXd or one of several chemotherapies chosen by the investigator, including docetaxel, paclitaxel, or irinotecan hydrochloride. The I-DXd is given as an intravenous infusion at a dose of 12 mg/kg on the first day of each 21-day treatment cycle. The study is open-label and phase 3, with treatments continuing according to the assigned group. During the study, participants will be monitored regularly for overall survival up to approximately 54 months from randomization. Researchers will assess disease progression, response rates, duration of response, and quality of life using specific questionnaires. Safety is also closely tracked through reports of adverse events and laboratory testing, including pharmacokinetic sampling at multiple time points. The study aims to provide comprehensive data on the benefits and risks of I-DXd in this patient group.
CONDITIONS
Brief Title
A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years or older
- Histologically or cytologically confirmed unresectable locally advanced or metastatic esophageal squamous cell carcinoma
- Disease progression after platinum-based chemotherapy and immune checkpoint inhibitor treatment, with a maximum of one prior systemic therapy line
- Adequate baseline tumor samples with sufficient tumor tissue
- At least one measurable lesion on CT or MRI not from a previously irradiated site, or with documented progression if lesion is in a previously irradiated site
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 within 7 days prior to first treatment cycle
You will not qualify if you...
- Prior treatment with orlotamab, enoblituzumab, other B7-H3 targeted agents, or ifinatamab deruxtecan
- Prior treatment with any topoisomerase inhibitor
- Histologically or cytologically confirmed adenosquamous carcinoma subtype
- Ineligibility for all comparator chemotherapies due to prior progression or intolerance
- Tumor invasion into adjacent organs at increased risk of bleeding or fistula
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis requiring treatment
- Recent cerebrovascular events or pulmonary embolism within past 6 months
- Clinically significant corneal disease
- History or current interstitial lung disease/pneumonitis requiring corticosteroids or suspected but unconfirmed by imaging
- Severe pulmonary compromise or related pulmonary conditions
- Chronic steroid treatment at doses of 10 mg prednisone daily or higher, except low-dose inhaled or topical steroids or intra-articular injections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation, up to approximately 54 months
Participants receive either intravenous infusions of I-DXd every 3 weeks or investigator's choice of chemotherapy (docetaxel, paclitaxel, or irinotecan HCl).
Intravenous infusions on Day 1 of every 21-day cycle (Q3W)
Duration - Up to approximately 54 months from randomization
Participants continue to be monitored for overall survival, disease progression, response to treatment, adverse events, and quality of life up to approximately 54 months after starting treatment.
Regular visits aligned with treatment cycles and survival assessments
Trial Site Locations
Total: 88 locations
1
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
2
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
3
Baptist Cancer Center
Memphis, Tennessee, United States, 38120
Actively Recruiting
4
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
5
John Peter Smith Hospital
Fort Worth, Texas, United States, 76104
Actively Recruiting
6
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
7
Institut Jules Bordet
Brussels, Belgium, 1070
Actively Recruiting
8
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
9
Antwerp University Hospital
Edegem, Belgium, 2650
Actively Recruiting
10
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
11
Anyang Cancer Hospital
Anyang, China, 455000
Actively Recruiting
12
Beijing Cancer Hospital
Beijing, China, 100142
Actively Recruiting
13
Jilin Cancer Hospital
Changchun, China, 130000
Actively Recruiting
14
Changzhou Cancer Hospital
Changzhou, China, 213001
Actively Recruiting
15
Sichuan cancer hospital
Chengdu, China, 610041
Actively Recruiting
16
West China Hospital Sichuan University
Chengdu, China, 610041
Actively Recruiting
17
Fujian Cancer Hospital
Fuzhou, China, 350015
Actively Recruiting
18
Harbin Medical University Cancer Hospital
Harbin, China, 150081
Actively Recruiting
19
The First Affiliated Hospital of Fujian Medical University
Hefei, China, 230088
Actively Recruiting
20
Jinan Central Hospital
Jinan, China, 250013
Actively Recruiting
21
Shandong Cancer Hospital
Jinan, China, 250117
Actively Recruiting
22
Affiliated Hospital of Jining Medical University
Jining, China, 272029
Actively Recruiting
23
Guangxi Medical University Affiliated Tumor Hospital
Nanning, China, 530021
Actively Recruiting
24
Liaoning Cancer Hospital and Institute
Shenyang, China, 110042
Actively Recruiting
25
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China, 453000
Actively Recruiting
26
The First Affiliated Hospital of Xinxiang Medical University
Weihui, China, 453100
Actively Recruiting
27
Hubei Cancer Hospital
Wuhan, China, 430000
Actively Recruiting
28
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China, 430022
Actively Recruiting
29
Zhongshan Hospital Xiamen University
Xiamen, China, 361004
Actively Recruiting
30
Subei Peoples Hospital
Yangzhou, China, 225001
Actively Recruiting
31
Sainte Catherine Institut du cancer Avignon en Provence
Avignon, France, 84918
Actively Recruiting
32
CHU Brest - Hôpital de la Cavale Blanche
Brest, France, 29609
Actively Recruiting
33
Institut Régional du Cancer de Montpellier
Montpellier, France, 34298
Actively Recruiting
34
Hôpital Européen Georges Pompidou
Paris, France, 75015
Actively Recruiting
35
CHU Poitiers - Hôpital la Milétrie
Poitiers, France, 86000
Actively Recruiting
36
Unité de recherche clinique ICANS
Strasbourg, France, 67033
Actively Recruiting
37
CHU Toulouse Rangueil Service dOncologie médicale
Toulouse, France, 31059
Actively Recruiting
38
Krankenhaus Nordwest GmbH
Frankfurt am Main, Germany, 60488
Actively Recruiting
39
Hämatologisch Onkologische Praxis Eppendorf HOPE
Hamburg, Germany, 20249
Actively Recruiting
40
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
41
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, Italy, 80131
Actively Recruiting
42
IOV - Istituto Oncologico Veneto IRCCS
Padova, Italy, 35128
Actively Recruiting
43
Fondazione Policlinico Gemelli
Rome, Italy, 00168
Actively Recruiting
44
National Cancer Center Hospital
Chūōku, Japan, 104-0045
Actively Recruiting
45
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
Actively Recruiting
46
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Actively Recruiting
47
Kagawa University Hospital
Kita-gun, Japan, 761-0793
Actively Recruiting
48
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, Japan, 650-0047
Actively Recruiting
49
Cancer Institute Hospital of JFCR
Kōtoku, Japan, 135-8550
Actively Recruiting
50
Shikoku Cancer Center
Matsuyama, Japan, 791-0280
Actively Recruiting
51
Aichi Cancer Center
Nagoya, Japan, 464-8681
Actively Recruiting
52
Osaka International Cancer Institute
Osaka, Japan, 541-8567
Actively Recruiting
53
Kindai University Hospital
Ōsaka-sayama, Japan, 589-8511
Actively Recruiting
54
Saitama Cancer Center
Saitama, Japan, 362-0806
Actively Recruiting
55
Hokkaido University Hospital
Sapporo, Japan, 060-8648
Actively Recruiting
56
SHOWA Medical University Hospital
Shinagawa-ku, Japan, 142-8666
Actively Recruiting
57
Keio University Hospital
Shinjuku-ku, Japan, 160-8582
Actively Recruiting
58
The University of Osaka Hospital
Suita-shi, Japan, 565-0871
Actively Recruiting
59
Shizuoka Cancer Center
Sunto-gun, Japan, 411-8777
Actively Recruiting
60
Kanagawa Cancer Center
Yokohama, Japan, 241-8515
Actively Recruiting
61
Erasmus MC
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
62
Zanamed Medical Clinic Sp z o o
Lublin, Poland, 20-362
Actively Recruiting
63
Mazowiecki Szpital Wojewódzki
Siedlce, Poland, 08-110
Actively Recruiting
64
Memorial Healthcare International S R L
Bucharest, Romania, 13823
Actively Recruiting
65
S.C Radiotherapy Center Cluj S.R.L
Comuna Floresti, Romania, 407280
Actively Recruiting
66
Centrul de Oncologie Sfantul Nectarie Craiova
Craiova, Romania, 200542
Actively Recruiting
67
S.C. Sigmedical Services SRL
Suceava, Romania, 720284
Actively Recruiting
68
Kyungpook National University Chilgok Hospital
Daegu, South Korea, 700-721
Actively Recruiting
69
National Cancer Center
Goyang-sisouth, South Korea, 10408
Actively Recruiting
70
Chonnam National University Hwasun Hospital
Hwasun-gun, South Korea, 58128
Actively Recruiting
71
Gachon University Gil Medical Center
Incheon, South Korea, 21565
Actively Recruiting
72
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
73
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 3722
Actively Recruiting
74
Asan Medical Center
Seoul, South Korea, 5505
Actively Recruiting
75
Samsung Medical Center
Seoul, South Korea, 6351
Actively Recruiting
76
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul, South Korea, 6591
Actively Recruiting
77
Korea University Guro Hospital
Seoul, South Korea, 8308
Actively Recruiting
78
Hospital Universitario de Burgos
Burgos, Spain, 9006
Actively Recruiting
79
Hospital General Universitario de Elche
Elche, Spain, 3203
Actively Recruiting
80
Hospital Univ Regional de Málaga Hosp Civil
Málaga, Spain, 29010
Actively Recruiting
81
Complejo Hospitalario Universitario de Orense
Ourense, Spain, 32005
Actively Recruiting
82
Hospital Universitario de Navarra
Pamplona, Spain, 31008
Actively Recruiting
83
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
84
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833
Actively Recruiting
85
China Medical University Hospital
Taichung, Taiwan, 40447
Not Yet Recruiting
86
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
87
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
88
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
Research Team
D
Daiichi Sankyo Contact for Clinical Trial Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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