A Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenous QLS5132 Combination Therapy in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 626
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and effectiveness of the investigational drug QLS5132 (injectable) in combination with other therapies for participants with advanced solid tumors. This is a multicenter, open-label study consisting of two parts: dose escalation and tumor-specific expansion.
The main questions it aims to answer are:
- In the dose-escalation part: What is the safety, tolerability, PK profile, and preliminary efficacy of QLS5132 combination therapy, and what are the recommended dose(s) for expansion?
- In the expansion part: What is the anti-tumor efficacy and further safety profile of QLS5132 combination therapy at the selected dose(s) in participants with specific tumor types?
Participants will:
- Be enrolled in sequential cohorts to receive QLS5132 in combination with other anticancer agents.
- Undergo regular assessments for safety, drug concentration levels (PK), and tumor response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Advanced solid tumors;
- •Measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1);
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •Adequate organ function;
- •Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral.
排除标准
- •Previous treatment with drugs targeting CLDN6 (including antibody-drug conjugates [ADCs]), or any drug containing topoisomerase I inhibitors (including ADCs);
- •Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 2 weeks with small molecule and within 4 weeks with biologic before the first dose of QLS5132;
- •Progressive or symptomatic brain metastases;
- •Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;
- •History of significant cardiac disease, or poorly controlled diabetes mellitus;
- •History of recurrent autoimmune diseases;
- •History of myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia (AML);
- •History of a second primary malignancy;
- •If female, is pregnant or breastfeeding;
- •Be allergic to any component of QLS5132 or its excipients.
研究组 & 干预措施
QLS5132 combined wtih bevacizumab
QLS5132 in combination with bevacizumab
干预措施: QLS5132; Bevacizumab (Drug)
QLS5132 combined wtih platinum
QLS5132 in combination with platinum, followed by sequential QLS5132 alone or in combination with bevacizumab
干预措施: QLS5132; Platinum; Bevacizumab (Drug)
QLS5132 combined wtih Olaparib
QLS5132 in combination with Olaparib, followed by sequential QLS5132 alone or in combination with bevacizumab
干预措施: QLS5132; Olaparib; Bevacizumab (Drug)
QLS5132 combined wtih immune checkpoint inhibitors
QLS5132 in combination with immune checkpoint inhibitors
干预措施: QLS5132; QL1706; QL2107 (Drug)
QLS5132 combined with immune checkpoint inhibitors and chemotherapy
QLS5132 in combination with immune checkpoint inhibitors and chemotherapy
干预措施: QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin (Drug)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: up to 2 years
Incidence and severity of adverse events
Maximum tolerated dose (MTD)
时间窗: From basline to Day 28
Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Recommended Phase 2 Dose (RP2D)
时间窗: up to 2 years
次要结局
未报告次要终点