NCT06823609招募中1 期
A Phase I Clinical Study to Evaluate Safety, Tolerability, PK Characteristic and Preliminary Efficacy of QLS-1304 in Patients With Advanced Malignant Tumors
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Dose limited toxicity (DLT) of QLS1304
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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.
研究组 & 干预措施
QLS1304 tablet
Experimental
干预措施: QLS1304 tablet (Drug)
结局指标
主要结局
Dose limited toxicity (DLT) of QLS1304
时间窗: up to 35 days
Recommended Phase II Dose (RP2D) of QLS1304
时间窗: up to 35 days
Maximum tolerated dose（MTD）of QLS1304
时间窗: up to 35 days
次要结局
- Cmax(through study completion, an average of 2 year)
- adverse event(from the first drug administration to within 30 days for the last treatment dose)
- Tmax(through study completion, an average of 2 year)
- AUC0-t(through study completion, an average of 2 year)
- objective response rate(ORR)(through study completion, assessed up to 24 months)
- CL/F(through study completion, an average of 2 year)
- AUC0-inf(through study completion, an average of 2 year)
- MRT(through study completion, an average of 2 year)
- Vd/F(through study completion, an average of 2 year)
- t1/2(through study completion, an average of 2 year)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
A first-in-human study of VG161 in participants with advanced malignant tumours that have not responded to conventional therapies.Advanced malignant solid tumorsCancer - Other cancer typesCancer - Any cancerACTRN12620000244909Virogin Biotech Australia Pty. Ltd.7
已完成
1 期
Clinical Phase I study to assess safety tolerability, pharmacokinetics and pharmacodynamics of ATROSAB (Anti-TNF-receptor 1 monoclonal antibody) in response to single ascending intravenous infusion doses. A single center, randomized, double blind, parallel group and placebo-controlled clinical trial in healthy male subjectsHealthy volunteersDRKS00004400Baliopharm GmbH27
招募中
不适用
A phase I trial of intravenously administered M6229 in critically ill sepsis patientsNL-OMON23213Amsterdam UMC, location AMC16
已完成
不适用
A phase I trial evaluating the safety, tolerability and pharmacokinetics of intravenously administered M6229 in critically ill sepsis patients - *HistoSeps*SepsisNL-OMON51932Academisch Medisch Centrum26
尚未招募
1 期
Salmonella Vaccine Immunogenicity and Safety (SaVIS) StudyPACTR202310834458532niversity of Oxford120