A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of QLS31901 for Injection in Patients With Advanced Malignant Tumors
试验速览
- 阶段
- 1 期
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a Phase 1, open label, non-randomised, dose-escalation single agent study with expansion cohorts for dose confirmation/safety and preliminary efficacy of QLS31901 in advanced or metastatic malignancies
详细描述
Study Design: This open label, multicenter, first in human study consists of 2 parts. Part 1 is a dose escalation to find the recommended dose for the expansion.
Part 2 is a dose expansion to confirm the dose of QLS31901 through further evaluation of safety, tolerability, Pk, preliminary antitumor activity, and functional target engagement.
The study includes three periods: Screening( up to 28 days prior to the first dose of study drug); Treatment(first dose of study drug with treatment cycles of 28 days); and Follow-up ( 30days 、60days and 90 days after the last dose) including survival follow-up checks every 3 months up to 12 months after the death of patient or the end of this clinical trial .
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 75 years, male or female.
- •Eastern Cooperative Oncology Group (ECOG) score of 0-
- •Life expectancy ≥ 12 weeks.
- •At least one measurable lesion by imaging according to RECIST v1.1 evaluation criteria
- •Patients who failed standard treatment or were absent of standard treatment and have a pathologically confirmed advanced malignant tumor.
- •Sufficient organ function before the first dose of the investigational product
排除标准
- •Prior anti-cancer immunotherapy(Those who have received PD1 / PDL1 can be included in this study).
- •Known allergy to the investigational product or any excipient or severe anaphylaxis to other monoclonal antibodies.
- •Received any of the following treatments or drugs prior to the first dose of the study:
- •Symptomatic CNS metastasis, leptomeningeal metastases, or spinal cord compression due to metastasis before signing of the informed consent form.
- •Patients with uncontrollable severe exudation (thoracic cavity, pericardium, abdominal cavity);
- •Presence of active autoimmune disease or has a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [patients whose condition can be controlled by thyroid hormone replacement therapy can be enrolled]; Subjects suffer from skin diseases that does not require systemic treatment, such as vitiligo, psoriasis, alopecia, type I diabetes, or childhood asthma that has completely alleviated and does not require any adult intervention can be enrolled. Asthmatic patients requiring bronchodilators for medical intervention cannot be enrolled);
研究组 & 干预措施
QLS31901
Part 1 (Dose escalation): QLS31901will be administered in sequential cohorts each receiving 1 of 6 doses of QLS31901 on day 1 of every 21-day cycle (3 weeks) via IV infusion. Dose escalation will continue until an MTD is reached.
Part 2 (Dose Expansion): The PK parameters of QLS31901 will be tested at 2-3 doses determined during the dose-escalation phase in subjects with advanced malignant tumor cohorts.
干预措施: QLS31901 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 21days
Safety and tolerability,as defined by the rate of treatment-related events as assessed by NCI CTCAE v5.0.
次要结局
未报告次要终点