An Open, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of QLC5513 in Combination With Epalolimab Tovolimab (QL1706) ± Platinum in Patients With Advanced or Metastatic Malignant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 290
- 主要终点
- The maximum tolerated dose (MTD)/maximum administration dose (MAD) and RP2D of QLC5513 combined with QL1706± platinum in patients with advanced solid tumors.
研究概览
简要总结
The goal of this Phase Ib/II interventional study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of QLC5513 combined with QL1706± platinum in the treatment of patients with advanced or metastatic malignant solid tumors. This study is divided into two phases: Phase Ib is the combined dose escalation phase, where dose escalation of QLC5513 combined with QL1706± platinum is conducted and RP2D is explored; In the Phase II tumor type expansion study stage, the primary objective is to evaluate the objective response rate (ORR) of QLC5513 combined with QL1706± platinum-based treatment in patients with advanced or metastatic malignant solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Has an eastern cooperative oncology group (ECOG) performance status of 0 to
- •Has adequate organ function.
- •The expected survival period is ≥3 months.
- •Based on the pathological report of the most recent biopsy or other pathological specimens, advanced or metastatic solid tumors confirmed by histology or cytology are not suitable for radical treatments such as surgery and radiotherapy.
- •According to the RECIST v1.1 evaluation criteria, the participants had at least one radiologically measurable lesion.
排除标准
- •Prior treatment with TROP2-targeting agents, ADCs with topoisomerase 1 inhibitor (TOP1i) payloads, or other TOP1i drugs.
- •There was symptomatic central nervous system (CNS) metastasis, leptomeningeal metastasis or spinal cord compression caused by metastasis before the first use of the investigational product.
- •Active, uncontrolled bacterial, fungal or viral infections.
- •Radiotherapy with more than 25% of the bone marrow exposed within 4 weeks prior to the first use of the investigational drug; Local radiotherapy (excluding brain radiotherapy) was performed within two weeks before the first use of the investigational drug.
- •Subjects with a history of a second malignant tumor other than the target indication within 5 years prior to signing the informed consent (excluding cured basal cell skin cancer, superficial bladder cancer, carcinoma in situ of the breast, papillary thyroid carcinoma, etc.).
- •Prior to the first dose of the investigational product, all reversible toxicities from prior anti-tumor therapy (excluding alopecia and pigmentation) have not recovered to ≤ Grade 1 (as assessed by CTCAE v5.0), with the exception that peripheral neuropathy must have not recovered to ≤ Grade
- •History of irAEs from prior immune checkpoint inhibitor treatment that required permanent discontinuation of the immune checkpoint inhibitor.
- •Active autoimmune disease that has required systemic treatment in the past 2 years.
研究组 & 干预措施
Arm A: QLC5513+QL1706
干预措施: QLC5513 IV infusion (Drug)
Arm A: QLC5513+QL1706
干预措施: QL1706, IV infusion (Biological)
Arm B: QLC5513+QL1706+ platinum
干预措施: QLC5513 IV infusion (Drug)
Arm B: QLC5513+QL1706+ platinum
干预措施: QL1706, IV infusion (Biological)
Arm B: QLC5513+QL1706+ platinum
干预措施: platinum, IV infusion (Drug)
结局指标
主要结局
The maximum tolerated dose (MTD)/maximum administration dose (MAD) and RP2D of QLC5513 combined with QL1706± platinum in patients with advanced solid tumors.
时间窗: up to 12 months
Number of participants who experience one or more adverse events(AEs).
时间窗: up to 48 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Objective Response Rate
时间窗: up to 36 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by investigator.
次要结局
- DOR(up to 48 months)
- PFS(up to 48 months)
- OS(up to 60 months)