Safety Study of MG1102 in Patients With Solid Tumors
A PHASE 1, OPEN LABEL, DOSE ESCALATION STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MG1102 IN PATIENTS WITH SOLID TUMORS
調査の概要
詳細な説明
This is an open-label, Dose Escalation Study, multicenter phase I study to evaluate the safety and tolerability, determine the pharmacokinetics, and obtain preliminary information regarding pharmacodynamics and efficacy of MG1102 in subjects with solid tumor.
Each subject will receive on dose of MG1102 followed by a 6-day rest period. If the initial dose is tolerated, subject will continue with the 21 days of MG1102 administration (5 days on treatment, 2 days off treatment for 3 weeks.) Subjects that have a tumor response as stable disease, may continue therapy on a compassionate use.
Study Duration : for a minimum of 8 weeks
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Seoul、大韓民国、120-752
- Yonsei Cancer Center, Yonsei University Severance Hospital
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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:
- 18 years of age or older
- Solid tumors refractory to conventional therapy or the subject does not tolerate the conventional therapy
- Evaluable disease or at least one measurable tumor mass by a radiographic technique
- Life expectancy ≥3 months
- Suitable for intravenous administration of study medication
- Signed written informed consent
- Adequate bone marrow, renal, and liver function
- Coagulation profile with aPTT and INR, each ≤ 1.5 x ULN
- No evidence of active Hepatitis B or Hepatitis C infection
- Proteinuria <100 mg
- ECOG performance status ≤2
- Female subjects must agree to use contraceptive measures
- Negative serum ß-hCG
- Ability and willingness to comply with the study protocol
Exclusion Criteria:
- Pregnant or lactating women
- Therapy with systemic anticoagulant or antithrombotic agentswithin 7 days prior to first dose
- Hemoptysis within 3 months prior to first dose
- Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 4 weeks prior to first dose
- Surgery or visceral biopsy within 28 days prior to first dose
- Minor surgical procedure performed within 7 days prior to first dose
- Prior exposure to MG1102
- Known history of HIV
- With active bacterial infections and/or receiving systemic antibiotics
- Current or past diagnosis of leukemia
- Known CNS metastases or clinical evidence of CNS
- Non-healing wound within past 2 weeks
- Bleeding diathesis or bleeding within 14 days prior to enrollment
- Clinically significant thrombosis
- Non-malignant GI bleeding, gastric stress ulcerations, or peptic ulcer disease
- History of idiopathic or hereditary angioedema
- History of sickle cell or any hemolytic anemia
- Require hemoglobin, WBC, or platelet transfusion support or use of hematopoietic growth factors within 2 weeks prior to entry
- Uncontrolled hypertension
- History of clinically significant renal disease
- History of significant medical illness of cardiac or CNS disease within the past 6 months
- Treatment with an investigational agent within the longest time frame of either 5 half-lives or 30 days of initiating study drug
- Medical or psychiatric illness
- Recreational substance use or psychiatric illness
- Known hypersensitivity to MG1102 or components of the formulation
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
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
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実験的：Greenstatin
Cohort 1 : 6 mg/m2 Cohort 2 : 12 mg/m2 Cohort 3 : 24 mg/m2 Cohort 4 : 48 mg/m2 Cohort 5 : 96 mg/m2 Cohort 6 : 192 mg/m2 28 Day Course Subjects will receive MG1102 (Recombinant human apolipoprotein(a) Kringle V ) by IV administration on Day 0. If no DLTs are observed during the 6 days following the initial infusion, the same dose will be administered once daily for 5 consecutive days followed by a 2-day rest period three times (over 21 days), completing the course on Day 27. Additional 21 Day Courses In the absence of a DLT, and in the case of stable disease or better, a subject may continue to receive MG1102 (Recombinant human apolipoprotein(a) Kringle V ) on a compassionate use basis at the same dose and regimen . |
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 |
|---|---|---|
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To investigate the safety and tolerability IV MG1102
時間枠：A minimum of 9 weeks
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Adverse events, physical examinations, vital signs, ECGs, clinical laboratory evaluations, lipid profiles
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A minimum of 9 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Each subject's serum drug concentration-time data to determine the pharmacokinetic profile of MG1102
時間枠：for 25 days
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for 25 days
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standard clinical serum tumor markers via serum samples to obtain preliminary information regarding the pharmacodynamics of MG1102
時間枠：A minimum of 10 weeks
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A minimum of 10 weeks
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Determination of response assessed by RECIST v1.1 and Choi criteria to obtain preliminary information regarding the efficacy of MG1102
時間枠：A minimum of 11 weeks
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A minimum of 11 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：hyunchul chung, dr、Yonsei Cancer Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。