Allogeneic WTX-212C in Advanced Solid Tumors

Официальное название

A Multicenter, Open-label, Single-arm Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Allogeneic WTX-212C Engineered Red Blood Cell Injection in Patients With Advanced Solid Tumors

Обзор

This is a multicenter, open-label, single-arm Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of allogeneic WTX-212C, an investigational allogeneic engineered red blood cell (RBC)-based product, in patients with advanced solid tumors who have failed standard therapies or have no available standard treatment options. The study consists of a dose-escalation phase using a 3+3 design followed by a dose-expansion phase. Participants will receive allogeneic WTX-212C via intravenous infusion. Tumor assessments will be performed every 6 weeks according to RECIST 1.1.

Подробное описание

This Phase I study aims to characterize the safety profile, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), pharmacokinetics, immunogenicity, and preliminary efficacy of allogeneic WTX-212C in patients with advanced solid tumors.

The dose-escalation phase will follow a traditional 3+3 design with predefined dose levels. The dose-expansion phase will further evaluate safety, PK, and antitumor activity at selected dose levels.

Exploratory analyses will include immune profiling, tumor microenvironment assessment, and evaluation of biomarkers such as PD-1/PD-L1 expression, tumor mutational burden (TMB), and microsatellite instability (MSI) status.

Вмешательства

• Препарат allogeneic WTX-212C
  allogeneic WTX-212C is an investigational allogeneic engineered red blood cell-based injectable product administered intravenously.

Первичные конечные точки

• Incidence of Dose-Limiting Toxicities (DLTs) [Срок оценки: Within 21 days after the first dose]
• Incidence and Severity of Treatment-Related Adverse Events (TRAEs) [Срок оценки: Up to 12 months]

Вторичные конечные точки (9)

• Maximum Tolerated Dose (MTD) [Срок оценки: Within 21 days after the first dose]
• Pharmacokinetic Parameters (Cmax) [Срок оценки: From first dose up to 12 months]
• Objective Response Rate (ORR) [Срок оценки: Up to 12 months]
• Disease Control Rate (DCR) [Срок оценки: Up to 12 months]
• Progression-Free Survival (PFS) [Срок оценки: Up to 12 months]
• Incidence of Anti-Drug Antibodies (ADA) [Срок оценки: From baseline up to 12 months]
• Pharmacokinetic Parameters (AUC) [Срок оценки: From first dose up to 12 months]
• Pharmacokinetic Parameters (Tmax) [Срок оценки: From first dose up to 12 months]
• Pharmacokinetic Parameters (T1/2) [Срок оценки: From first dose up to 12 months]

Критерии участия

Критерии включения

• Age 18-75 years
• Histologically or cytologically confirmed advanced solid tumors
• At least one measurable lesion per RECIST 1.1
• ECOG performance status ≤1
• Adequate organ function
• Life expectancy ≥12 weeks

Критерии исключения

• Uncontrolled serious medical conditions
• Active or uncontrolled infections
• Symptomatic or unstable CNS metastases
• History of severe hypersensitivity to biologic agents
• Autoimmune diseases requiring systemic treatment
• Prior severe immune-related adverse events
• Conditions affecting red blood cell integrity

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhejiang Provincial Hospital — Ханчжоу

Идентификаторы

NCT: NCT07556653 · WTX-212C-uRBC-IIT-001CN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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