To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors

Официальное название

A Phase Ib / II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients with Advanced Recurrent or Metastatic Digestive System Tumors

Обзор

The purpose of this study is to evaluate the preliminary efficacy, safety, tolerability and pharmacokinetics of KC1036 in participants with advanced recurrent or metastatic digestive system tumors.

Подробное описание

This is an open label, non-randomized，phase 1b/2 study to explore the preliminary antitumor activity of KC1036 in patients with advanced recurrent or metastatic digestive system tumors under BID or QD regimen.

The study will consist of two parts:

Part 1: QD regimen

To evaluate the efficacy and safety of KC1036 in the treatment of advanced recurrent, unresectable and / or metastatic digestive system tumors under 60mg QD regimen.

Part 2: BID regimen

Dose-Escalation part : To explore the safety of KC1036 under 20mg BID, 30mg BID and 40mg BID in patients with advanced recurrent or metastatic digestive system tumors.

Dose-Expansion part : According to the results of Dose-Escalation, an appropriate BID regimen was selected for Dose-Expansion to evaluate the effectiveness and safety of KC1036 in patients with advanced recurrent, unresectable and / or metastatic digestive system tumors.

Вмешательства

• Препарат KC1036
  KC1036 are administered orally QD or BID in 21-day cycles.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: approximately 2 year.]

Вторичные конечные точки (8)

• Progression-free survival (PFS) [Срок оценки: approximately 2 year]
• Disease Control Rate (DCR) [Срок оценки: approximately 2 year.]
• Duration of Response (DOR) [Срок оценки: approximately 2 year.]
• Pharmacokinetics (PK) profile: Cmax [Срок оценки: approximately 2 year.]
• Pharmacokinetics (PK) profile: Tmax [Срок оценки: approximately 2 year.]
• Pharmacokinetics (PK) profile: T1/2 [Срок оценки: approximately of 2 year.]
• Pharmacokinetics (PK) profile: AUC [Срок оценки: approximately of 2 year.]
• Adverse events (AEs) [Срок оценки: approximately of 2 year.]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed malignant digestive system tumors;
• Patients with advanced recurrent, unresectable and / or metastatic digestive system tumors who have failed standard or conventional treatment:( definition of treatment failure: intolerable toxic and side effects, disease progression during treatment recurrence after treatment);
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Life expectancy > 12 weeks;
• BMI≥18.0;
• Has adequate Hematologic, renal, and hepatic function;
• Patients should participate in the study voluntarily and sign informed consent.

Критерии исключения

• Any patient who is known to have central nervous system (CNS) metastasis with clinical symptoms;
• Other kinds of malignancies;
• Gastrointestinal abnormalitiest;
• Cardiovascular and cerebrovascular diseases;
• Previous treatment with small molecule vascular targeting inhibitor；
• Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks before enrollment;
• Involved in other clinical trials within 4 weeks before enrollment;
• Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks before enrollment;
• Uncontrolled massive ascites,pleural/pericardial effusion;
• Uncontrolled ongoing or active bacterial, viral or fungal infectious; Fever of unknown cause (> 38.5 ℃) occurred within 2 weeks before enrollment;
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection ;
• Pregnant or lactating women or those who do not take contraceptives, including men;
• Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;
• Inability to comply with protocol required procedures.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 13 центров

• Cancer Hospital, Chinese Academy of Medical Sciences — Пекин
• The first affiliated hospital of bengbu medical college — Bengbu
• Chongqing University Three Gorges Hospital — Чунцин
• Fujian Cancer Hospital — Fujian
• Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University — Henan
• The First Affiliated Hospital of Xinxiang Medical University — Henan
• Hubei Cancer Hospital — Hubei
• Union Hospital Tongji Medical College Huazhong University of Science and Technologe — Hubei
• … и ещё 5 центров

Идентификаторы

NCT: NCT05260385 · KC1036-II-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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