Phase I Clinical Trial of CDP1 in Patients With Advanced Solid Tumors
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
調査の概要
詳細な説明
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.
To evaluate the immunogenicity of CDP1 in patients with advanced solid tumor.
To evaluate the initial efficacy of CDP1 in patients with advanced solid tumor.
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Zhang Xiaolei, doctor
- 電話番号:(+86)021-50276381
- メール:zhangxiaolei@dragonboatbio.com
研究連絡先のバックアップ
- 名前:Wang Qihui, doctor
- 電話番号:(+86)021-5027638
- メール:Qihui.Wang@dragonboatbio.com
研究場所
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Shanghai
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Shanghai、Shanghai、中国
- Dragonboat Biopharmaceutical,Co.,Ltd
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age: 18-75 (inclusive), gender unlimited;
- 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.);
- 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;
Exclusion Criteria:
- 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 or within 5 half-lives of the known drug (whichever is longer) .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 other clinical trials within 4 weeks before enrollment, or within 5 half lives of known drugs, whichever is the longer elution / withdrawal time;
- Have received EGFR inhibitor treatment before;
- 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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 介入モデル:順次割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:anti-EGFR monoclonal antibody
Single-dose Phase:This is a dose-escalation trial, 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. Cohort 1:400mg/m2;Cohort 2: 500mg/m2;Cohort 3: 750mg/m2; Multi-dose Phase:Multiple administrations of three Cohorts of subjects were followed by continuous administration of CDP1. |
Single-dose Phase: Cohort 1:400mg/m2;Cohort 2: 500mg/m2;Cohort 3: 750mg/m2; Multi-dose Phase:Cohort 1 Dosing regimen is the first administration of 400mg/m2, followed by 250mg/m2/W;Cohort 2,3 Dosing regimen is the first administration of 500mg/m2, followed by 500mg/m2/2W.
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Dose Limiting Toxicities (DLT)
時間枠:At the end of Cycle 1 (28 days).
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Number of participants with dose limiting toxicity (DLT)
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At the end of Cycle 1 (28 days).
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Recommended phase II dose (RP2D)
時間枠:At least one cycle of treatment(6 months).
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Recommended phase II dose (RP2D) evaluated on the first cycle.
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At least one cycle of treatment(6 months).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Pharmacokinetic parameters: Observed Maximum Serum Concentration (Cmax) of CDP1 After Infusion
時間枠:Up to 28 Days
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Pharmacokinetic parameters Cmax for CDP1
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Up to 28 Days
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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
時間枠:Up to 28 Days
|
AUC(0-t) for CDP1
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Up to 28 Days
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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
時間枠:Up to 28 Days
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Pharmacokinetic parameters: AUC(0-00) for CDP1
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Up to 28 Days
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Pharmacokinetic parameters: Apparent Terminal Half-life (t1/2) of CDP1 After Infusion
時間枠:Up to 28 Days
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Pharmacokinetic parameters T1/2 for CDP1
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Up to 28 Days
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Immunogenicity indicators: Number of participants with positive anti-drug antibodies (ADA)
時間枠:an average of 6 months
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Immunogenicity indicators: Number of participants with positive anti-drug
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an average of 6 months
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Immunogenicity indicators: Number of participants with positive neutralizing antibodies
時間枠:an average of 6 months
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Immunogenicity indicators: Number of participants with positive neutralizing antibodies
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an average of 6 months
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Objective response rate (ORR)
時間枠:an average of 6 months
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The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
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an average of 6 months
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Progression-free survival (PFS)
時間枠:an average of 6 months
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Progression-free survival is defined as the time from the start of treatment with CDP1 until the first documentation of disease progression or death due to any cause, whichever occurs first.
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an average of 6 months
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協力者と研究者
捜査官
- 主任研究者:Zheng Li, doctor、West China Hospital
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CDP100003
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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CDP1の臨床試験
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Dragonboat Biopharmaceutical Company LimitedWest China Hospital募集
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Dragonboat Biopharmaceutical Company LimitedShanghai East Hospitalわからない
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Dragonboat Biopharmaceutical Company LimitedWest China Hospital; Shanghai Public Health Clinical Centerわからない