A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors

Официальное название

An Open-label Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors

Обзор

The goal of this Phase I clinical trial is to evaluate the safety, tolerability, and pharmacokinetic characteristics of the JYP0035 capsule in patients with advanced solid tumors. The main questions it aims to answer are: * What is the safety profile of JYP0035 when administered to these patients? * How does JYP0035 capsule behave in the body pharmacokinetically? Participants will: * Receive escalating doses of JYP0035 capsule during the dose-escalation phase (PART-1). * Continue with the identified dose in the dose-expansion phase (PART-2). As this is a single-arm study, there is no comparison group.

Вмешательства

• Препарат JYP0035 Experimental Drug Treatment
  Single dose intervention

Первичные конечные точки

• Assess the adverse event rate of this clinical trial [Срок оценки: From 8 weeks after the first administration up to week 52]

Вторичные конечные точки (1)

• Assess Area Under the Curve(AUC) [Срок оценки: From 8 weeks after the first administration up to week 52]

Критерии участия

Критерии включения

• Patients voluntarily participate in the clinical trial and sign the informed consent form
• Age 18 years and above (inclusive), and below 75 years of age (inclusive), with no gender restrictions
• ECOG(Eastern Cooperative Oncology Group)performance status of 0 or 1
• Expected survival time of ≥3 months
• During the screening period, female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to administration of the study drug
• Participants agree to use reliable contraception methods from signing the informed consent form until 6 months after the last dose of the study drug. This includes, but is not limited to: abstinence, vasectomy in males, female sterilization, effective intrauterine devices, and effective contraceptive medications

Критерии исключения

• Participants have not recovered to normal or ≤ Grade 1 from any adverse events and/or complications caused by any previous treatments before the first administration of the study drug, excluding hair loss and pigmentation
• Patients with imaging (CT or MRI) showing tumor invasion into major blood vessels (such as the aorta, pulmonary arteries and veins, vena cava, etc.)
• Patients who have had clinically significant cardiovascular or cerebrovascular diseases within 6 months before the first administration, which, in the investigator's judgment, may interfere with the patient's full participation in the study; atrial fibrillation; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention
• Patients who had history of type 1 diabetes, type 2 diabetes, or gestational diabetes
• Individuals with other malignancies or with a history of other malignant tumors
• Individuals with a history of severe allergies, or who are allergic to any active or inactive ingredients of the study drug
• Pregnant or breastfeeding patients
• Researchers consider participants unsuitable for this clinical study due to any clinical or laboratory abnormalities or other reasons

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 · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06158477 · JYP0035M101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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