Recruiting NCT06644781

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

Phase III Interventional Esophageal Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Ifinatamab deruxtecan, Docetaxel, Paclitaxel, Irinotecan hydrochloride (HCl).
Who it may be relevant to: Registry conditions: Esophageal Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Belgium, China, Denmark, France +12
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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).

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.

Interventions

Drug Ifinatamab deruxtecan
Intravenous administration
Drug Docetaxel
Intravenous administration
Drug Paclitaxel
Intravenous administration
Drug Irinotecan hydrochloride (HCl)
Intravenous administration

Primary outcome measures

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

Secondary outcome measures (11)

Progression-free survival (PFS) [Time frame: 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]
Objective Response Rate (ORR) [Time frame: 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]
Duration of Response (DoR) [Time frame: 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) [Time frame: 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]
Change from baseline in European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Score (EORTC QLQ-C30) [Time frame: Baseline up to 54 months]
Change from baseline in European Organisation for Research and Treatment of Cancer Esophageal Cancer Module Score (EORTC OES18) [Time frame: Baseline up to 54 months]
Incidence of Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events of Special Interest (AESIs) [Time frame: Baseline up to 54 months]
Percentage of Participants Who Have Treatment-emergent ADA [Time frame: Baseline up to 54 months]
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for I-DXd [Time frame: 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)]
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for Total Anti-B7-H3 Antibody [Time frame: 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)]
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for MAAA-1181a [Time frame: 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)]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

China · 20 centers

Anyang Cancer Hospital — Anyang
Beijing Cancer Hospital — Beijing
Jilin Cancer Hospital — Changchun
Changzhou Cancer Hospital — Changzhou
Sichuan cancer hospital — Chengdu
West China Hospital Sichuan University — Chengdu
Fujian Cancer Hospital — Fuzhou
Harbin Medical University Cancer Hospital — Harbin
… and 12 more centers

Japan · 17 centers

National Cancer Center Hospital — Chūōku
Hiroshima University Hospital — Hiroshima
National Cancer Center Hospital East — Kashiwa
Kagawa University Hospital — Kita-gun
Kobe City Hospital Organization Kobe City Medical Center General Hospital — Kobe
Cancer Institute Hospital of JFCR — Kōtoku
Shikoku Cancer Center — Matsuyama
Aichi Cancer Center — Nagoya
… and 9 more centers

United States · 13 centers

Mayo Clinic Hospital — Phoenix
Providence Medical Foundation — Fullerton
Univ of California Irvine College of Medicine — Orange
Henry Ford Health System — Detroit
Mayo Clinic Rochester — Rochester
MidAmerica Cancer Care - American Oncology Partners — Kansas City
Morristown Medical Center — Morristown
Maimonides Cancer Center — Brooklyn
… and 5 more centers

Germany · 11 centers

Charité - Campus Charité Mitte — Berlin
Vivantes Klinikum Im Friedrichshain — Berlin
Universitaetsklinikum Bonn Aoer — Bonn
Universitaetsklinikum Carl Gustav Carus TU Dresden — Dresden
Krankenhaus Nordwest GmbH — Frankfurt am Main
Hämatologisch Onkologische Praxis Eppendorf HOPE — Hamburg
Asklepios Klinik Altona — Hamburg
Universitaetsklinikum Jena — Jena
… and 3 more centers

Spain · 11 centers