Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours.

Официальное название

A Phase I/II, Open-label, Multicentre, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SCTB41 in Patients with Advanced Malignant Solid Tumours

Обзор

This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.

Вмешательства

• Препарат SCTB41
  SCTB41 of different doses,IV,every 3 weeks

Первичные конечные точки

• Dose-Limiting toxicity(DLT) [Срок оценки: :From Day 0 up to Day 21]
• Objective response rate (ORR) [Срок оценки: Up to 2 years]

Вторичные конечные точки (3)

• Disease control rate (DCR) [Срок оценки: Up to 2 years]
• Progression-free survival (PFS) [Срок оценки: Up to 2 years]
• Overall survival (OS) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Voluntarily sign the informed consent form (ICF);
• Male or female, ≥18 years old;
• Survival duration more than 3 months;
• ECOG score ≤ 1 point;
• Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;
• Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours;
• Adequate organ and bone marrow function.

Критерии исключения

• Participants with brainstem, meningeal, spinal metastases, orcompression; active central nervous system metastases;
• Other malignancies diagnosed;
• History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep veinthrombosis within 6 months prior to enrollment;
• Presence of any active autoimmune disease or a history of autoimmunedisease with an expected recurrence;
• Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment;
• Need for immunosuppressive drugs within 2 weeks prior to enrollment oranticipated during the study;
• Significant coagulopathy or other evident risk of bleeding;
• uncontrolled effusions in the serous cavities within 4 weeks before enrollment；
• Major surgery or significant trauma within 4 weeks prior to enrollment;presence of unhealed skin wounds, surgical sites, trauma sites, severe- Page 3 of 4 \[DRAFT\] -mucosal ulcers, or fractures, or if the Investigator deems the participantunsuitable for the study;
• History of permanent discontinuation of immunotherapy due to immunerelated toxicity or occurrence of ≥ Grade 3 irAEs;
• Known severe allergy to similar antibody drugs;
• Presence of active infection；
• History of organ transplantation or stem cell transplantation;
• Pregnant or breastfeeding female; women of childbearing potential withpositive pregnancy test within 7 days before the enrollment; participants(including males of childbearing potential and their female partners, and females of childbearing potential and their male partners) unwilling to use medically recognized effective contraception during the study and for 6 months after treatment ends.

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

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT06600022 · SCTB41-X101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗