A Phase I Study of TQB2930 Injection in Patients With Advanced Cancers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
TQB2930 is an anti-HER2 (Human Epidermal Growth Factor Receptor 2) bispecific antibody that can simultaneously bind two epitopes of HER2, leading to a dual HER2 signal blockage. This is a phase I study to evaluate the safety, tolerability and effectiveness of TQB2930 injection in subjects with advanced malignancies.
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
- •1 Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
- •2 Male or female patient 18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks;
- •3 Histologically or cytologically confirmed, locally advanced tumors, Priority will be given to subjects with HER2 positive solid tumor;
- •4 Malignant tumor that failed from standard treatment or had no standard treatment;
- •5 According to the RECIST 1.1 standard, patient with at least one evaluable lesion;
- •6 The main organs function well;
- •7 Male or female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.
排除标准
- •1 Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 3 years;
- •2 History of uncontrolled intercurrent illness;
- •3 Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;
- •4 Patients with known symptomatic brain metastases;
- •5 Receiving any other investigational agent within 4 weeks before first dose;
- •6 Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.
研究组 & 干预措施
TQB2930 injection
Drug:Weekly intravenous infusion of TQB2930 injection,21 days as a treatment cycle. (2.5mg/kg, 5mg/kg, 10mg/kg) Drug:Every two weeks intravenous infusion of TQB2930 injection , 28 days as a treatment cycle.(20mg/kg) Drug:Every three weeks intravenous infusion of TQB2930 injection, 21 days as a treatment cycle. (30mg/kg)
干预措施: TQB2930 injection (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: At the end of Cycle 1 (each cycle is 21 or 28 days).
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Dose Limiting Toxicity (DLT)
时间窗: At the end of Cycle 1 (each cycle is 21 or 28 days)
DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred from the first dose to the end of the first treatment cycle.
Adverse events (AE) rate
时间窗: From date of the first dose until the date of 28 days after last dose or new anti-tumor treatment, whichever came first.
The occurrence and severity of all AEs
次要结局
- immunogenicity(Cycle 1 Day 1, Cycle 2 Day1, Cycle 4 Day1, Cycle 7 Day1, Cycle 12 Day1: pre-dose and end of the infusion.(each cycle is 21 or 28 days))
- Pharmacokinetics: The area under the curve (AUC)(Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.(21 or 28 days each))
- Pharmacokinetics:Peak concentration (Cmax)(Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.21 or 28 days each)
- Pharmacokinetics: T1/2(Cycle1Day1, Cycle1Day8, Cycle1Day815, Cycle2 Day1, Cycle2Day8, Cycle2Day15 and Cycle3Day1: pre-dose, Cycle1Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion. Cycle2Day1:at 0.5, 4, 8, 24, 48, 72, and 240 hours after infusion.21 or 28 days each)
- Objective Response Rate (ORR)(From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks)
- Disease control rate (DCR)(From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks)
- Duration of Response (DOR)(From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks)
- Progression-free survival (PFS)(From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks)
- Overall survival(OS)(From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100weeks)