NCT04151810已完成1 期
Phase I Clinical Trial to Evaluate Safety, Tolerance and Pharmacokinetics of Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1) in Patients With Advanced Solid Tumors
Dragonboat Biopharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年12月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicities (DLT)
研究概览
简要总结
The main purpose of this study was to evaluate the safety and tolerability of CDP1 in patients with advanced solid tumor, to explore dose limited toxicity (DLT), and to determine the recommended dose (RP2D) for phase II clinical trials.
详细描述
OBJECTIVES:
Primary:
To evaluate the safety and tolerability of CDP1 in patients with advanced solid tumor, to explore the dose limited toxicity (DLT), and to determine the recommended dose (RP2D) for phase II clinical trial.
Secondary:
To evaluate the pharmacokinetics of CDP1 in patients with advanced solid tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 (inclusive), gender unlimited;
- •Dose-escalation phase: Patients with advanced solid tumors confirmed by histology or cytology who have failed to receive the existing standard treatment or are unable to tolerate or unwilling to accept the standard treatment (tumor types benefiting from anti EGFR treatment, including but not limited to colorectal cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, penile squamous cell carcinoma, etc.); Dose-expansion phase: Patients with recurrent or metastatic advanced penile squamous cell carcinoma confirmed by histology or cytology who are not suitable for radical resection;
- •For colorectal cancer patients, RAS / BRAF was detected as wild-type.
- •ECOG physical strength score: 0-1;
- •Expected survival time over 3 months;
- •According to RECIST1.1, there is at least one tumor lesion that can be assessed;
- •No serious abnormalities of blood system, liver function, renal function and coagulation function: Neutrophils ≥1.5×10 9 /L, platelets ≥ 75 × 10 g/L, hemoglobin ≥ 90g/L;Total bilirubin ≤ 1.5ULN, ALT ≤ 2.5ULN, AST ≤ 2.5ULN (ALT ≤ 5ULN, AST ≤ 5ULN in patients with liver metastasis); Blood creatinine ≤ 1.5ULN; APTT ≤ 1.5ULN, Pt ≤ 1.5ULN, INR ≤ 1.5ULN;
- •Eligible fertile patients (male and female) must agree to use a reliable method of contraception (hormonal or barrier or abstinence) during the trial and for at least 12 weeks after the last dose; Women of childbearing age must have a negative blood or urine pregnancy test within 7 days of enrollment;
- •Subjects shall give informed consent to the study before the trial and sign written informed consent voluntarily;
排除标准
- •Received chemotherapy, biotherapy, radiotherapy, endocrinotherapy, small molecule targeted therapy and other anti-tumor treatment (except for nitrosourea, mitomycin C and fluorouracil oral drugs) within 4 weeks before starting to use the study drug: 6 weeks for nitrosourea or mitomycin C; The interval between the last oral administration of fluorouracil, such as tegio and capecitabine, and the use of the study drug is at least 2 weeks; Received big molecule anti-tumor drugs which had long half-lives (such as anti PD-1 or PD-L1 drugs) within 8 weeks before enrollment;
- •Received other investigational products within 4 weeks before enrollment;
- •Have received EGFR inhibitor treatment before and failed treatment;
- •Patients who have failed previous platinum therapy (Recurrent within 6 months after completion of platinum neoadjuvant/adjuvant therapy defined as treatment failure, cannot be included in this study; If the recurrence occurs after more than 6 months, the patient can be included);
- •Patients who had undergone major organ surgery (excluding puncture biopsy) or had significant trauma but not recovered within 4 weeks before admission;
- •The adverse reactions of the previous anti-tumor treatment have not been restored to CTCAE 5.0 grade evaluation ≤ 1 (except for hair loss); the radiotoxicity has not been restored to CTCAE 5.0 grade evaluation grade 1 and below (except for no effect).
- •The central nervous system metastasis without treatment or with clinical symptoms is not suitable for the group according to the judgment of the researcher; the patients suspected of brain or pia mater diseases with clinical symptoms need to be excluded by CT / MRI (flow chart notes);
- •Uncontrolled systemic infection;
- •Have a history of immunodeficiency, including HIV antibody test;
- •Treponema pallidum antibody positive;
- •Patients with chronic hepatitis B virus (HBV) infection, and the number of copies of HBV is more than 1000 IU / ml; patients with active hepatitis C virus (HCV) infection (note of index flow chart);
- •Serious cardiovascular disease history: including ventricular arrhythmia requiring clinical intervention; acute coronary syndrome, congestive heart failure, stroke or other cardiovascular events of level III and above within 6 months; NYHA heart function grade ≥ level II or left ventricular ejection fraction (LVEF) < 50%; poor control of hypertension, which is judged to be uncomfortable by researchers Join group;
- •Patients with other serious systemic diseases (including respiratory system, endocrine system, etc.) who are not suitable for clinical trials according to the judgment of researchers;
- •Known dependence on alcohol or drugs;
- •People with mental disorder or poor compliance;
- •Pregnant or lactating women;
- •In the past, when using biological products drugs, severe transfusion reaction occurred;
- •The investigator believes that the subject is not suitable for this clinical study due to any clinical or laboratory examination abnormality or other reasons.
研究组 & 干预措施
anti-EGFR monoclonal antibody
Experimental
This is a dose-escalation phase, all participants will receive treatment with CDP1. Participants enrolled in this trial may receive one of the following doses dependent upon time of enrolment into the study.
干预措施: CDP1 (Drug)
anti-EGFR monoclonal antibody + chemotherapy
Experimental
This is a dose-expansion phase, participants with penile squamous cell carcinoma will receive CDP1 in combination with TIP chemotherapy.
干预措施: CDP1 (Drug)
anti-EGFR monoclonal antibody + chemotherapy
Experimental
This is a dose-expansion phase, participants with penile squamous cell carcinoma will receive CDP1 in combination with TIP chemotherapy.
干预措施: TIP chemotherapy (Drug)
结局指标
主要结局
Dose Limiting Toxicities (DLT)
时间窗: At the end of Cycle 1 (28 days).
Number of participants with dose limiting toxicity (DLT)
Recommended phase II dose (RP2D)
时间窗: At least one cycle of treatment(6 months).
Recommended phase II dose (RP2D) evaluated on the first cycle.
次要结局
- Pharmacokinetic Parameters: Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Infusion AUC(0-t) for CDP1(Up to 28 Days)
- Immunogenicity indicators: Number of participants with positive neutralizing antibodies(an average of 6 months)
- Objective response rate (ORR)(an average of 6 months)
- Pharmacokinetic parameters: Observed Maximum Serum Concentration (Cmax) of CDP1 After Infusion(Up to 28 Days)
- Immunogenicity indicators: Number of participants with positive anti-drug antibodies (ADA)(an average of 6 months)
- Pharmacokinetic parameters: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-00) After Infusion Pharmacokinetic parameters: AUC(0-00) for CDP1(Up to 28 Days)
- Pharmacokinetic parameters: Apparent Terminal Half-life (t1/2) of CDP1 After Infusion(Up to 28 Days)
- Progression-free survival (PFS)(an average of 6 months)
研究者
研究点 (1)
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