A Study of KC1036 in Patients with Advanced Solid Tumors

Официальное название

A Phase I, Open-label, Dose Escalation Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of KC1036 in the Patients with Advanced Recurrent or Metastatic Solid Tumors

Обзор

The purpose of this study is to evaluate the safety，tolerability, pharmacokinetics, and preliminary efficacy of KC1036 in participants with advanced recurrent or metastatic solid tumors. The trial will be divided into three parts: dose-escalation phase, dose-expansion phase, RP2D-extension phase.

Вмешательства

• Препарат KC1036
  Part 1: Dose-escalation phase , KC1036 10mg\~80mg, consists of 5 Cohorts. Part 2: Dose-expansion phase, consists of 3\~4 Cohorts based on part 1. Part 3:RP2D-extension phase, Recommended dose of KC1036 based on part 1and part 2.

Первичные конечные точки

• Maximum tolerated dose (MTD) [Срок оценки: First 4 weeks after initial administration of KC1036]
• Adverse events (AEs) [Срок оценки: From enrollment up to 30 days after last dose]

Вторичные конечные точки (9)

• Pharmacokinetics (PK) profile: Cmax [Срок оценки: First 4 weeks after initial administration of KC1036]
• Pharmacokinetics (PK) profile: Tmax [Срок оценки: First 4 weeks after initial administration of KC1036]
• Pharmacokinetics (PK) profile: T1/2 [Срок оценки: First 4 weeks after initial administration of KC1036]
• Pharmacokinetics (PK) profile: AUC0-t and AUC0-∞ [Срок оценки: First 4 weeks after initial administration of KC1036]
• Objective Response Rate (ORR) [Срок оценки: Every 6 weeks for the duration of study participation; estimated to be 12 months]
• Progression-free survival (PFS) [Срок оценки: Every 6 weeks for the duration of study participation; estimated to be 12 months]
• Disease Control Rate (DCR) [Срок оценки: Every 6 weeks for the duration of study participation; estimated to be 12 months]
• Duration of Response (DOR) [Срок оценки: Every 6 weeks for the duration of study participation; estimated to be 12 months]
• Overall Survival (OS) [Срок оценки: From the first medication to death due to any cause; estimated to be the subject's death, loss to follow-up, or end of the study]]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed recurrent or metastatic solid tumors;
• Patients who have failed standard or conventional treatment, Including chemotherapy, targeted therapy, immunotherapy:

Documented disease progression after, or refractory to, or intolerant of prior standard or established therapy known to provide clinical benefit for their condition; or documented disease progression within 24 weeks after prior adjuvant/neoadjuvant therapy;

• At least one measurable lesion (by RECIST 1.1);
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Life expectancy > 12 weeks;
• Patients should participate in the study voluntarily and sign informed consent.

Критерии исключения

• Untreated brain metastases or symptoms of brain metastases cannot be controlled more than 4 weeks;
• Other kinds of malignancies;
• Hematologic, renal, and hepatic function abnormities;
• Risk of bleeding;
• Gastrointestinal abnormalitiest;
• Cardiovascular and cerebrovascular diseases;
• Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks of enrollment;
• Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE V5.0 grade 0 or 1 with the exception of alopecia;
• Involved in other clinical trials within 4 weeks of enrollment;
• Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks days of enrollment;
• History of organ allograft;
• Need immunosuppressive agents or systemic or absorbable topical hormone therapy for immunosuppression;
• Uncontrolled ongoing or active infection;
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;
• Pregnant or lactating women or those who do not take contraceptives, including men;
• Suffering from mental and neurological diseases;
• 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

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• ChongQing University Cancer Hospital — Чунцин
• The First Affiliated Hospital of Hainan Medical University — Haikou
• West China Hospital — Чэнду

Идентификаторы

NCT: NCT04387916 · KC1036-I-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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