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

ConditionEsophageal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ifinatamab deruxtecan

    Drug

    Intravenous administration

  • Docetaxel

    Drug

    Intravenous administration

  • Paclitaxel

    Drug

    Intravenous administration

  • Irinotecan hydrochloride (HCl)

    Drug

    Intravenous administration

Treatment groups

510 Participants
are divided into 2 treatment groups
Group A: I-DXdExperimental treatment 1 intervention
Group B: Investigator's Choice of Chemotherapy (ICC)Active comparator 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame
From the date of randomization to the date of death due to any cause, up to approximately 54 months

Secondary outcomes

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.

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
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.

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
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.

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
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daiichi Sankyo

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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