RecruitingPhase 1Phase 2NCT06792435

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

A Phase I/Ⅱ, First-in-Human Study of XNW27011 in Patients with Locally Advanced And/or Metastatic Solid Tumors

Sponsor

Evopoint Biosciences Inc.

Enrollment

240 participants

Start Date

Jul 27, 2023

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Cancer Ovarian Cancer Gastric Carcinoma Gastroesophageal Junction Adenocarcinoma Pancreatic Adenocarcinoma Metastatic Lung Cancer (NSCLC)Colorectal Cancer Metastatic

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new experimental drug called XNW27011 in people with advanced solid tumors — including stomach, pancreatic, lung, colorectal, and other cancers — that have not responded to standard treatments. The goal is to find the safest and most effective dose. **You may be eligible if...** - You are 18 or older with a confirmed advanced or metastatic solid tumor - Your cancer has stopped responding to standard therapy, or no standard therapy is available - Your overall health status is adequate (ECOG 0–2) - You can provide a tumor tissue sample **You may NOT be eligible if...** - You have active brain metastases that are untreated - You have serious heart, liver, or immune system problems - You have received other cancer treatments too recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXNW27011

Eligible patient(s) in each dose cohort will receive the assigned XNW27011 dose administration every 3 weeks (Q3W, cycle) until intolerable toxicity, progression of the disease without clinical benefit, or withdrawal of informed consent. An accelerated titration scheme will be used for the first two dose levels (0.6 mg/kg and 1.2 mg/kg) starting from 0.6 mg/kg dose as follows: The first patient will be enrolled for 0.6 mg/kg dose. If the subject shows no significant toxicity in cycle 1 (DLT observation period), the second patient will be enrolled for 1.2 mg/kg. 3 + 3 dose escalation:3 patients will be enrolled to the dose cohort first，If 1 of 3 patients experiences a DLT, up to 3 more patients will be enrolled in the same dose cohort.. If none of the additional 3 patients experiences a DLT, dose escalation will continue to the next dose.Dose escalation will be stopped when 2 or more patients out of 3 to 6 patients at the same dose level experience a DLT.

DRUGXNW27011

Group A: Gastric/gastroesophageal junction adenocarcinoma with CLDN18.2 expression, tentatively expand with 3.6, 3.0, 2.4 mg/kg. Group B: Pancreatic adenocarcinoma with CLDN18.2 expression, tentatively expand with 3.6, 3.0, 2.4 mg/kg. Group C: Ovarian cancer with CLDN18.2 expression, tentatively expand with 3.6, 3.0, 2.4 mg/kg. Group D: Other tumors with CLDN18.2 expression, including but not limited to esophagus adenocarcinoma, lung cancer, colorectal cancer, and biliary tract cancer,tentatively expand with 3.6, 3.0, 2.4 mg/kg.