A Phase I Study of TQB2102 Injection in Patients With Advanced Cancers
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 219
- 试验地点
- 12
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a phase I study to evaluate the safety, tolerability and effectiveness of TQB102 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
- •Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
- •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;
- •Histologically or cytologically confirmed, locally advanced tumors, Priority will be given to subjects with HER2 positive solid tumo;
- •Malignant tumor that failed from standard treatment or had no standard treatment;
- •According to the RECIST 1.1 standard, patient with at least one evaluable lesion;
- •The main organs function well;
- •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
- •Concurrent secondary malignancy or other malignancy with no evidence of disease for more than 3 years;
- •History of uncontrolled intercurrent illness;
- •Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;
- •Patients with known symptomatic brain metastases;
- •Receiving any other investigational agent within 4 weeks before first dose;
- •Patients with severe hypersensitivity after the use of monoclonal antibodies
- •History of interstitial lung disease or pneumonia;
- •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
TQB2102 injection
intravenous infuse TQB2102 injection every three weeks, 21 days as a treatment cycle. (1.5mg/kg, 3mg/kg, 4.5mg/kg, 6mg/kg, 7.5mg/kg, 9mg/kg)
干预措施: TQB2102 injection (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: During the first treatment cycle (21 days).
DLT was defined as toxicities that meet pre-defined severity criteria (according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle (21 days) of treatment.
Maximum tolerated dose (MTD)
时间窗: During the first treatment cycle (21 days).
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
The occurrence rate of all adverse events (AEs)
时间窗: From date of the first dose until 28 days after last dose or new anti-tumor treatment, whichever came first.
The occurrence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)
Dose escalation: recommended phase 2 dose (RP2D)
时间窗: Up to 2 years
The RP2D of DT-9081 is determined using pharmacokinetics, pharmacodynamics and safety data of the dose escalation part of the study.
次要结局
- Disease control rate (DCR)(Baseline up to 2 years.)
- Progression-free survival (PFS)(Baseline to the date of documented disease progression, up to 2 years.)
- Immunogenicity(Before infusion on Cycle1 Day1, Cycle2 Day1, Cycle 4 Day1, Cycle7 Day1, Cycle12 Day1 (each cycle is 21 days). 90 days after the end of the last infusion.)
- Peak concentration (Cmax)(Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4 hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 days)
- Terminal half-life (T1/2)(Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4 hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 day)
- Area under the curve (AUC)(Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 days)
- Duration of Response (DOR)(Baseline to the date of documented disease progression, up to 2 years.)
- Overall survival(OS)(Baseline to the date of death from any cause, up to 2 years.)
- Objective Response Rate (ORR)(Baseline up to 2 years.)