Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Malignant Tumors

Официальное название

A Phase I Clinical Study to Evaluate Safety, Tolerability, PK Characteristic and Preliminary Efficacy of QLS-1304 in Patients With Advanced Malignant Tumors

Обзор

This study is a multi-center, open label, dose escalation/dose expansion phase I clinical trial aimed at evaluating the safety, tolerability, PK characteristics, and preliminary efficacy characteristics of QLS1304 monotherapy in patients with advanced malignant solid tumors. This study was divided into two stages: dose escalation and dose expansion.

Вмешательства

• Препарат QLS1304 tablet
  QLS1304 monotherapy dose escalation and expansion

Первичные конечные точки

• Dose limited toxicity (DLT) of QLS1304 [Срок оценки: up to 35 days]
• Maximum tolerated dose（MTD）of QLS1304 [Срок оценки: up to 35 days]
• Recommended Phase II Dose (RP2D) of QLS1304 [Срок оценки: up to 35 days]

Вторичные конечные точки (10)

• adverse event [Срок оценки: from the first drug administration to within 30 days for the last treatment dose]
• Cmax [Срок оценки: through study completion, an average of 2 year]
• objective response rate(ORR) [Срок оценки: through study completion, assessed up to 24 months]
• Tmax [Срок оценки: through study completion, an average of 2 year]
• AUC0-t [Срок оценки: through study completion, an average of 2 year]
• AUC0-inf [Срок оценки: through study completion, an average of 2 year]
• CL/F [Срок оценки: through study completion, an average of 2 year]
• Vd/F [Срок оценки: through study completion, an average of 2 year]
• MRT [Срок оценки: through study completion, an average of 2 year]
• t1/2 [Срок оценки: through study completion, an average of 2 year]

Критерии участия

Критерии включения

• Volunteer to participate in this study, sign an informed consent form and have good compliance;
• Age ≥ 18 years old, Male or female
• ECOG score: 0-1
• Expected survival ≥ 12 weeks
• Local recurrent or metastatic advanced malignant solid tumor confirmed by histopathology or cytopathology;
• Failed to standard treatment or has no standard treatment scheme;
• Baseline presence of at least one evaluable lesion according to the RECIST v1.1;
• The functional level of important organs is basically normal, meeting the requirements of the scheme
• Female subjects with fertility and male subjects must agree to use highly effective contraception during the study treatment period and within 180 days after the last medication;
• Female subjects with fertility must have a negative serum HCG test within 7 days before the first medication in the study, and must be in non lactation.
• Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent

Критерии исключения

• 1\. Subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug.
• Subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug.
• Subjects require long-term or high-dose use of non-steroidal drugs.
• Subjects have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1.
• Subjects have a known or suspected severe allergy to theinvestigational drug or any of its components Subjects have other active malignant tumors within 5 years before the first use of the investigational drug.
• Subjects have brain metastases and/or carcinomatous meningitis or leptomeningeal disease.
• Subjects have active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, pulmonary fibrosis, or other diseases, symptoms, or signs of severe lung function impairment.
• Subjects are unable to swallow tablets or had gastrointestinal abnormalities that the investigator assessed as potentially affecting drug absorption.
• Subjects have a history of severe cardiovascular or cerebrovascular disease within 6 months before the first use of the investigational drug.
• Subjects have a hypertension medial history that blood is not well controlled despite treatment with multiple antihypertension drugs.

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 · 1 центр

• Fudan University Cancer Hospital — Шанхай

Идентификаторы

NCT: NCT06823609 · QLS1304-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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