A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors

Официальное название

A Phase I First-in-Human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants With Locally Advanced/Metastatic Solid Tumors

Обзор

This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants with Locally Advanced/Metastatic Solid Tumors

Вмешательства

• Препарат SIM0686
  Administered intravenously
• Препарат SIM0686
  Administered intravenously

Первичные конечные точки

• Dose escalation: Dose limited toxicity (DLT) [Срок оценки: At the end of Cycle 1(each cycle is 21 days)]
• Dose escalation phase: Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: The whole dose escalation phase，an average of 2 years]
• Cohort expansion phase：Overall Response Rate (ORR) [Срок оценки: The whole Cohort expansion phase，an average of 2 years]

Критерии участия

Критерии включения

• Voluntary participation and signature of informed consent form;
• At least 18 years old, male, or female;
• Participants with histologically and/or cytologically confirmed locally advanced/metastatic solid tumors;
• Participants should have at least one evaluable or measurable tumor lesion (RECIST v1.1);
• Participants have failed the standard of therapy in the locally advanced/metastatic setting
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1;
• Expected survival ≥12 weeks;
• Adequate organ and bone marrow function;
• Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue, or fresh biopsies within 6 months before first administration for evaluation of FGFR2b expression levels

Критерии исключения

• Active second primary malignancies within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.
• Participant has symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 2 weeks of first dose of study treatment.
• Active or chronic corneal disorder, history of corneal transplantation, keratitis, keratoconjunctivitis, keratopathy, keratoconus, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
• Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging screening.
• Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.
• Has received prior therapies within the following time frames prior to the first dose of study treatment:

• Previous cytotoxic therapy, anticancer targeted small molecules (e.g., tyrosine kinase inhibitors) within 2 weeks.
• Anti-cancer antibody, immune checkpoint inhibitor or ADC within 5 half-lives or 4 weeks (whichever is shorter).
• Chinese medicines/herbal preparations with anticancer indication taken within 2 weeks.
• Radiation therapy within 4 weeks.
• Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.
• Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
• Active or chronic hepatitis B or hepatitis C infection;

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 10 центров

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Harbin Medical University Cancer Hospital — Haerbin
• The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital — Чжэнчжоу
• Hunan Cancer Hospital — Чанша
• Nanjing Tianyinshan Hospital — Нанкин
• Cancer Hospital of Shandong First Medical University（Shandong Cancer Hospital&Institute） — Цзинань
• Fudan University Shanghai Cancer Center — Шанхай
• Shanghai Gobroad Cancer Hospital — Шанхай
• … и ещё 2 центра

Идентификаторы

NCT: NCT07050459 · SIM0686-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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