ClinicaliQ Trial Snapshot
- A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01) — Recruiting • Phase III • Oncology • NCT06644781.
- Treatment being tested: Ifinatamab deruxtecan (I-DXd), a novel antibody-drug conjugate targeting DLR3, is being evaluated for efficacy and safety in patients with advanced or metastatic esophageal squamous cell carcinoma who have progressed after platinum-based chemotherapy.
- Patient eligibility overview: Study includes adults with unresectable advanced or metastatic ESCC who have received prior platinum-based systemic therapy and immunotherapy, representing a heavily pretreated population with limited standard treatment options.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
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 Snapshot
- : 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). 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.