Actively Recruiting
XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.
Led by Evopoint Biosciences Inc. · Updated on 2025-02-07
240
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older who provide written informed consent
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor
- Tumor has failed standard therapy, is intolerable, or no standard therapy exists
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Estimated life expectancy greater than 12 weeks
- At least one measurable cancer lesion as defined by RECIST 1.1
- Adequate organ function based on specified laboratory tests
- For Phase II, confirmed CLDN18.2 tumor expression by immunohistochemistry
- Female patients of childbearing potential agree to use highly effective birth control during and for 180 days after the study
- Male patients with female partners of childbearing potential agree to use medically acceptable birth control and refrain from sperm donation during and for 180 days after the study
You will not qualify if you...
- Prior severe allergic reaction or intolerance to monoclonal antibodies or Topoisomerase I Inhibitor-based ADCs
- Acquired or congenital immunodeficiency or organ transplantation
- Recent myocardial infarction, heart failure, severe angina, or uncontrolled hypertension
- Active gastrointestinal bleeding, peptic ulcer, intestinal obstruction, lung fibrosis, kidney failure, or uncontrolled diabetes
- History of or uncontrolled brain tumors or significant cerebrovascular events within 6 months
- Current or past difficult-to-control mental illness
- HIV, syphilis requiring treatment, or active hepatitis B or C infection
- Active infections requiring systemic treatment within 2 weeks before dosing
- Clinically significant uncontrollable pleural fluid or ascites
- Adverse events from prior anti-tumor treatments not recovered to Grade 0 or 1 (except alopecia)
- Recent participation in other drug trials or recent anti-tumor therapy within specified time frames
- Recent major surgery or interventional treatments within 4 weeks before dosing
- Long-term systemic steroid therapy (over 7 days at 20 mg prednisone/day or equivalent)
- Recent live vaccinations within 4 weeks before dosing or planned during the study
- Pregnancy, breastfeeding, or positive pregnancy test at screening
- Poor compliance or deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Actively Recruiting
Research Team
Y
Yingjie Zhao
CONTACT
Z
zhenhao Ma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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