Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT06644781

Reclutamento in corso

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

Interventistico

Fase 3

Henry Ford Health System

Sponsor: Daiichi Sankyo

Ultimo Aggiornamento: 12 gennaio 2026

Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

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).

Mostra Descrizione Dettagliata

Categoria di Trattamento

Anticorpi Monoclonali, Chemioterapia

Mutazioni richieste

Nessuno

Studio Iniziato

27 marzo 2025

Ultimo Aggiornamento dello Sponsor

12 gennaio 2026

Completamento Stimato

1 giugno 2028

Contatto dello studio

Nome:Daiichi Sankyo Contact for Clinical Trial Information

Email:CTRinfo_us@daiichisankyo.com

Telefono:9089926400

Idoneità

Criteri di Inclusione

Participants must meet all of the following criteria to be eligible for randomization into the study:

1. Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).

2. Has histologically or cytologically documented unresectable locally advanced or metastatic ESCC according to American Joint Committee on Cancer 8th edition staging system on ESCC.

3. 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.

4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content as defined in the Laboratory Manual.

5. 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.

6. Has an ECOG PS of 0 or 1 within 7 days prior to Cycle 1 Day 1.

Criteri di Esclusione

Participants who meet any of the following criteria will be disqualified from entering the study:

1. Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.

2. Has received any topoisomerase inhibitor.

3. Has histologically or cytologically confirmed adenosquamous carcinoma subtype.

4. Is ineligible to all the chemotherapies in the comparator arm due to prior progression or intolerance.

5. 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.

6. 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.

7. Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event, or pulmonary embolism.

8. Has a clinically significant corneal disease.

9. 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.

10. 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.

11. 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.

Pensi che questo studio appaia erroneamente?

Dettagli del Disegno

AllocazioneRandomized

Modello di InterventoParallel Assignment

MascheramentoNone (Open Label)

Numero da Arruolare510

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: Participants who are randomized to receive an intravenous infusion of I-DXd 12 mg/kg on Day 1 of every 21-day cycle (Q3W).

Interventi:

Ifinatamab deruxtecan
Docetaxel
Paclitaxel
Irinotecan hydrochloride (HCl)

Misure di Esito

Misure di Esito Primarie

Overall Survival (OS)From the date of randomization to the date of death due to any cause, up to approximately 54 months

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

Misure di Esito Secondarie

Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for Total Anti-B7-H3 AntibodyCycle 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)

Plasma pharmacokinetic parameters will be assessed using noncompartmental methods.

Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for MAAA-1181aCycle 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)

Plasma pharmacokinetic parameters will be assessed using noncompartmental methods.

Progression-free survival (PFS)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

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.

Objective Response Rate (ORR)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

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.

Duration of Response (DoR)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

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.

Disease Control Rate (DCR)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

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.

Change from baseline in European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Score (EORTC QLQ-C30)Baseline up to 54 months

Change from baseline in European Organisation for Research and Treatment of Cancer Esophageal Cancer Module Score (EORTC OES18)Baseline up to 54 months

Incidence of Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events of Special Interest (AESIs)Baseline up to 54 months

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.

Percentage of Participants Who Have Treatment-emergent ADABaseline up to 54 months

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

Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for I-DXdCycle 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)

Plasma pharmacokinetic parameters will be assessed using noncompartmental methods.

Aggiungi studio ai preferiti

Condividi Studio

Scarica lo studio

Pensi che questo studio appaia erroneamente?

Segnala Studio

Scarica lo studio

Siti dello Studio

Questo studio ha 88 siti

Henry Ford Health System

Detroit, Michigan, US

In fase di reclutamento

Detroit, Michigan, 48202 US

Henry Ford Health System

In fase di reclutamento

Nagoya, 464-8681 JP

Aichi Cancer Center

In fase di reclutamento

Hiroshima, 734-8551 JP

Hiroshima University Hospital

In fase di reclutamento

Leuven, 3000 BE

UZ Leuven

In fase di reclutamento

Saitama, 362-0806 JP

Saitama Cancer Center

In fase di reclutamento

Paris, 75015 FR

Hôpital Européen Georges Pompidou

In fase di reclutamento

Brussels, 1200 BE

Cliniques Universitaires Saint-Luc

In fase di reclutamento

Matsuyama, 791-0280 JP

Shikoku Cancer Center

In fase di reclutamento

Kashiwa, 277-8577 JP

National Cancer Center Hospital East

Non ancora in reclutamento

Taichung, 40447 TW

China Medical University Hospital

In fase di reclutamento

Beijing, 100142 CN

Beijing Cancer Hospital

In fase di reclutamento

Fairfax, Virginia, 22031 US

Virginia Cancer Specialists

In fase di reclutamento

Harbin, 150081 CN

Harbin Medical University Cancer Hospital

In fase di reclutamento

Osaka, 541-8567 JP

Osaka International Cancer Institute

In fase di reclutamento

Memphis, Tennessee, 38120 US

Baptist Cancer Center

In fase di reclutamento

Jinan, 250117 CN

Shandong Cancer Hospital

In fase di reclutamento

Milan, 20133 IT

Fondazione IRCCS Istituto Nazionale dei Tumori

In fase di reclutamento

Tainan, 70403 TW

National Cheng Kung University Hospital

In fase di reclutamento

Taipei, 11217 TW

Taipei Veterans General Hospital

In fase di reclutamento

Rotterdam, 3015 GD NL

Erasmus MC

In fase di reclutamento

Edegem, 2650 BE

Antwerp University Hospital

In fase di reclutamento

Comuna Floresti, 407280 RO

S.C Radiotherapy Center Cluj S.R.L

In fase di reclutamento

Chengdu, 610041 CN

West China Hospital Sichuan University

In fase di reclutamento

Jinan, 250013 CN

Jinan Central Hospital

In fase di reclutamento

Montpellier, 34298 FR

Institut Régional du Cancer de Montpellier

In fase di reclutamento

Yokohama, 241-8515 JP

Kanagawa Cancer Center

In fase di reclutamento

Sapporo, 060-8648 JP

Hokkaido University Hospital

In fase di reclutamento

Elche, Alicante, 3203 ES

Hospital General Universitario de Elche

In fase di reclutamento

Kaohsiung City, 833 TW

Kaohsiung Chang Gung Memorial Hospital

In fase di reclutamento

Sevilla, Sevilla, 41009 ES

Hospital Universitario Virgen Macarena

In fase di reclutamento

Fort Worth, Texas, 76104 US

John Peter Smith Hospital

In fase di reclutamento

Sunto-gun, 411-8777 JP

Shizuoka Cancer Center

In fase di reclutamento

Xiamen, 361004 CN

Zhongshan Hospital Xiamen University

In fase di reclutamento

Shinjuku-ku, 160-8582 JP

Keio University Hospital

In fase di reclutamento

Ōsaka-sayama, 589-8511 JP

Kindai University Hospital

In fase di reclutamento

Taipei, 100225 TW

National Taiwan University Hospital

In fase di reclutamento

Jining, 272029 CN

Affiliated Hospital of Jining Medical University

In fase di reclutamento

Frankfurt am Main, 60488 DE

Krankenhaus Nordwest GmbH

In fase di reclutamento

Fullerton, California, 92835 US

Providence Medical Foundation

In fase di reclutamento

Wuhan, 430022 CN

Union Hospital Tongji Medical College Huazhong University of Science and Technology

In fase di reclutamento

Kita-gun, 761-0793 JP

Kagawa University Hospital

In fase di reclutamento

Changchun, 130000 CN

Jilin Cancer Hospital

In fase di reclutamento

Burgos, Burgos, 9006 ES

Hospital Universitario de Burgos

In fase di reclutamento

Brussels, 1070 BE

Institut Jules Bordet

In fase di reclutamento

Pamplona, Navarra, 31008 ES

Complejo Hospitalario de Navarra (CHN)

In fase di reclutamento

Shenyang, 110042 CN

Liaoning Cancer Hospital and Institute

In fase di reclutamento

Kobe, 650-0047 JP

Kobe City Hospital Organization Kobe City Medical Center General Hospital

In fase di reclutamento

Ourense, Ourense, 32005 ES

Complexo Hospitalario Universitario de Ourense

In fase di reclutamento

Nanning, 530021 CN

Guangxi Medical University Affiliated Tumor Hospital

In fase di reclutamento

Wuhan, 430000 CN

Hubei Cancer Hospital

In fase di reclutamento

Rome, 00168 IT

Fondazione Policlinico Gemelli

In fase di reclutamento

Nashville, Tennessee, 37203 US

SCRI Oncology Partners

In fase di reclutamento

Anyang, 455000 CN

Anyang Cancer Hospital

In fase di reclutamento

Napoli, 80131 IT

Azienda Ospedaliera Universitaria Luigi Vanvitelli

In fase di reclutamento

Suita-shi, 565-0871 JP

The University of Osaka Hospital

In fase di reclutamento

Hwasun-gun, 58128 KR

Chonnam National University Hwasun Hospital

In fase di reclutamento

Incheon, 21565 KR

Gachon University Gil Medical Center

In fase di reclutamento

Seongnam-si, 13620 KR

Seoul National University Bundang Hospital

In fase di reclutamento

Seoul, 5505 KR

Asan Medical Center

In fase di reclutamento

Chūōku, 104-0045 JP

National Cancer Center Hospital

In fase di reclutamento

Seoul, 6351 KR

Samsung Medical Center

In fase di reclutamento

Seoul, 3722 KR

Severance Hospital, Yonsei University Health System

In fase di reclutamento

Seoul, 8308 KR

Korea University Guro Hospital

In fase di reclutamento

Padua, 35128 IT

IOV - Istituto Oncologico Veneto IRCCS

In fase di reclutamento

Kōtoku, 135-8550 JP

Cancer Institute Hospital of JFCR

In fase di reclutamento

Chengdu, 610041 CN

Sichuan cancer hospital

In fase di reclutamento

Tianjin, 453000 CN

Tianjin Medical University Cancer Institute and Hospital

In fase di reclutamento

Weihui, 453100 CN

The First Affiliated Hospital of Xinxiang Medical University

In fase di reclutamento

Brest, 29609 FR

CHU Brest - Hôpital de la Cavale Blanche

In fase di reclutamento

Bucharest, 13823 RO

Memorial Healthcare International S R L

In fase di reclutamento

Craiova, 200542 RO

Centrul de Oncologie Sfantul Nectarie Craiova

In fase di reclutamento

Suceava, 720284 RO

S.C. Sigmedical Services SRL

In fase di reclutamento

Daegu, 700-721 KR

Kyungpook National University Chilgok Hospital

In fase di reclutamento

Goyang-sisouth, 10408 KR

National Cancer Center

In fase di reclutamento

Seoul, 6591 KR

The Catholic University of Korea, Seoul St. Marys Hospital

In fase di reclutamento

Changzhou, 213001 CN

Changzhou Cancer Hospital

In fase di reclutamento

Fuzhou, 350015 CN

Fujian Cancer Hospital

In fase di reclutamento

Hefei, 230088 CN

The First Affiliated Hospital of Fujian Medical University

In fase di reclutamento

Yangzhou, 225001 CN

Subei Peoples Hospital

In fase di reclutamento

Avignon, 84918 FR

Sainte Catherine Institut du cancer Avignon en Provence

In fase di reclutamento

Poitiers, 86000 FR

CHU Poitiers - Hôpital la Milétrie

In fase di reclutamento

Strasbourg, 67033 FR

Unité de recherche clinique ICANS

In fase di reclutamento

Toulouse, 31059 FR

CHU Toulouse Rangueil Service dOncologie médicale

In fase di reclutamento

Hamburg, 20249 DE

Hämatologisch Onkologische Praxis Eppendorf HOPE

In fase di reclutamento

Shinagawa-ku, 142-8666 JP

SHOWA Medical University Hospital

In fase di reclutamento

Lublin, 20-362 PL

Zanamed Medical Clinic Sp z o o

In fase di reclutamento

Siedlce, 08-110 PL

Mazowiecki Szpital Wojewódzki

In fase di reclutamento

Málaga, 29010 ES

Hospital Univ Regional de Málaga Hosp Civil

Loading Maps...