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XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 6 months later Jun 30, 2025 → Dec 30, 2026
See other at-risk trials from Astellas Pharma Global Development, Inc.

Record History

  1. Primary completion pushed from Jun 30, 2025 to Dec 30, 2026 Sponsor changed: Evopoint Biosciences Inc. to Astellas Pharma Global Development, Inc. · Enrollment closed, study ongoing · Completion pushed from Dec 31, 2025 to Jun 30, 2027 · 2 morev4 Show 5 more changesShow less
    • Sponsor changed: Evopoint Biosciences Inc. to Astellas Pharma Global Development, Inc.
    • Enrollment closed, study ongoing
    • Completion pushed from Dec 31, 2025 to Jun 30, 2027
    • Site details revised
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv3
  3. Study title shortened, about 5 wordsv2 See this version in full on ClinicalTrials.gov ↗
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a global, multi-center, open-label, Phase I/II first-in-human study of XNW27011 monotherapy as an investigational product (IP) in patients with locally advanced and/or metastatic solid tumors who have failed or are intolerant to standard therapies. XNW27011 is an antibody-drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), a transmembrane protein important to tight junctions. The study consists of 2 parts: Part 1 is the dose-escalation phase (Phase I), and Part 2 is the does-expansion phase (Phase II). In phase I part of the study, approximately 42 patients with locally advanced and/or metastatic solid tumors will be enrolled, irrespective of CLDN18.2 expression. However, the most recently available tumor tissue specimen will be collected (if available) for a retrospective CLDN18.2 expression confirmation. In phase II part of the study, only patients with confirmed CLDN18.2 expression by IHC in the central laboratory will be enrolled.The phase II part of the study will consist of the following four groups，Up to three dose cohorts for each patient group are planned currently. Each dose cohort will include approximately 20 patients. Approximately 240 patients evaluable will be enrolled in Phase Ⅱ part of the study.
Trial Details
NCT Number NCT06792435
Lead Sponsor Astellas Pharma Global Development, Inc.
Collaborators: Evopoint Biosciences Inc.
Conditions Pancreatic Adenocarcinoma Metastatic, Lung Cancer (NSCLC), Ovarian Cancer, Colorectal Cancer Metastatic, Biliary Tract Cancer, Gastric Carcinoma, Gastroesophageal Junction Adenocarcinoma
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov