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

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.

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	2023-07-27
Primary Completion	2026-12-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-11