Идёт набор NCT06349408

IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

Фаза I С лечением Locally Advanced Solid Tumor

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: IBI3001.
Кому может быть актуально: Состояния в реестре: Locally Advanced Solid Tumor. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австралия, Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

Обзор

This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.

Вмешательства

Препарат IBI3001
The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the study. IBI3001 is proposed to be administered by intravenous infusion (IV)

Первичные конечные точки

Number of subjects with adverse events [Срок оценки: 24 months]
Number of subjects with clinically significant changes in physical examination results [Срок оценки: 24 months]
Number of subjects with clinically significant changes in vital signs [Срок оценки: 24 months]
MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs) [Срок оценки: 24 months]

Вторичные конечные точки (12)

Plasma concentration (Cmax) of IBI3001 [Срок оценки: 24 months]
Area under the curve (AUC) of IBI3001 [Срок оценки: 24 months]
Time to maximum concentration (Tmax) of IBI3001 [Срок оценки: 24 months]
Clearance (CL) of IBI3001 [Срок оценки: 24 months]
Volume of distribution (V) of IBI3001 [Срок оценки: 24 months]
Half-life (T1/2) of IBI3001 [Срок оценки: 24 months]
Immunogenicity of IBI3001 [Срок оценки: 24 months]
Objective response rate (ORR) [Срок оценки: 24 months]
Duration of response (DoR) [Срок оценки: 24 months]
Disease control rate (DCR) [Срок оценки: 24 months]
Time to response (TTR) [Срок оценки: 24 months]
Progression free survival (PFS) [Срок оценки: 24 months]

Критерии участия

Критерии включения

Male or female participants ≥ 18 years old;
Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
Has an anticipated life expectancy of ≥ 12 weeks;
Adequate bone marrow and organ function:
At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion.
Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks.

Критерии исключения

Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan;
Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study;
Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
Known symptomatic central nervous system (CNS) metastases.
History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
History of endotracheal or gastrointestinal stent implantation;
Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
Esophageal or gastric varices requiring immediate intervention;
Not eligible to participate in this study at the discretion of the investigator;
Do not have adequate treatment washout period before study drug administration. -

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

Здоровые добровольцы: Нет