Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer

Официальное название

A Phase 1 Multicenter, Open-label Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer

Обзор

The main purpose of this study is to evaluate the safety and tolerability of IBI3009 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) of IBI3009.

Вмешательства

• Препарат IBI3009
  Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3009)

Первичные конечные точки

• Numbers of subjects with adverse events [Срок оценки: Up to 3 years]
• Number of subjects with clinically significant changes in physical examination results [Срок оценки: Up to 3 years]
• Number of subjects with clinically significant changes in electrocardiogram [Срок оценки: Up to 3 years]
• Number of subjects with clinically significant changes in vital signs [Срок оценки: Up to 3 years]
• Dose limiting toxicities (DLTs) [Срок оценки: Up to 28 days]

Вторичные конечные точки (12)

• area under the curve (AUC) [Срок оценки: Up to 3 years]
• maximum concentration (Cmax) [Срок оценки: Up to 3 years]
• time to maximum concentration (Tmax) [Срок оценки: Up to 3 years]
• clearance (CL) [Срок оценки: Up to 3 years]
• apparent volume of distribution (V) [Срок оценки: Up to 3 years]
• half-life (t1/2) [Срок оценки: Up to 3 years]
• anti-drug antibody (ADA) [Срок оценки: Up to 3 years]
• objective response rate (ORR) [Срок оценки: Up to 3 years]
• duration of response (DoR) [Срок оценки: Up to 3 years]
• time to response (TTR) [Срок оценки: Up to 3 years]
• progression free survival (PFS) [Срок оценки: Up to 3 years]
• overall survival (OS) [Срок оценки: Through out the study (an average of 3 years)]

Критерии участия

Критерии включения

• Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
• Male or female subjects ≥ 18 years old. For Part 1, age ≥18 years and ≤75 years;
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
• Minimum life expectancy of ≥ 12 weeks;
• Adequate organ function confirmed at screening period;
• Histologically or cytologically confirmed unresectable,metastatic or Extensive-Stage small cell lung cancer (SCLC).

Критерии исключения

• Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study;
• Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator's discretion) prior to the first dose of the study drug;
• Known allergies, hypersensitivity, or intolerance to IBI3009 or its excipients;
• Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator's discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.;
• Women who are pregnant, have positive results in pregnancy test or are lactating;
• Not eligible to participate in this study at the discretion of the investigator.

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 · 7 центров

• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• The First Affiliated Hospital of Fujian Medical University — Фучжоу
• Henan Cancer Hospital — Чжэнчжоу
• Hunan Cancer Hospital — Чанша
• The First Affiliated Hospital of Nanchang University — Nanchang
• Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong C — Цзинань
• Zhejiang Cancer Hospital — Ханчжоу

Австралия · 3 центра

• Westmead Hospital — Westmead
• Wollongong Hospital — Wollongong
• Austin Hospital — Heidelberg

Идентификаторы

NCT: NCT06613009 · CIBI3009A101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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