Study of CD137 Agonist ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma
A Study of CD137 Agonist ADG106 Administered Intravenously in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma
This is a Phase 1, open-label, dose-escalation, multicenter study of ADG106 in subjects with advanced or metastatic solid tumors and/or relapsed/refractory non-Hodgkin lymphoma. ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb. It binds to the activated human T cells via a T cell receptor CD137. T cell is a kind of lymphocyte (a subtype of white blood cells) that protects bodies by eliminating tumor cells, and normal cells infected with viruses or bacteria. By binding to CD137, the study drug is expected to enhance the activity of activated T cells and thus stimulate a more intense immune attack to kill tumor cells. ADG106 is expected to enhance the activity of activated T cells.
The primary objective of the study is to assess safety and tolerability at increasing dose levels of single agent ADG106 in subjects with advanced or metastatic solid tumors and/or non Hodgkin lymphoma Secondary Objectives
- To characterize the pharmacokinetic (PK) profiles of ADG106
- To evaluate the immunogenicity of ADG106
- To evaluate the potential anti-tumor effect of ADG106 Exploratory Objective To identify the potential biomarkers of ADG106
調査の概要
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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Indiana
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Lafayette、Indiana、アメリカ、47905
- Horizon Oncology Research
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Texas
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San Antonio、Texas、アメリカ、78229
- NEXT Oncology
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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
- Male or female, 18 years of age or older at the time of consent.
- Provide written informed consent.
- Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor and/or non-Hodgkin lymphoma who are refractory or relapsed from standard therapy and who have exhausted all available therapies.
- Life expectancy of 12 weeks or greater.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- At least one measurable lesion per RECIST 1.1 for solid tumors and per Lugano Classification for non-Hodgkin lymphoma.
- Adequate organ and bone marrow function
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to study drug administration.
Exclusion Criteria
- Active central nervous system primary or secondary malignancies, active seizure disorder, spinal cord compression, or carcinomatous meningitis.
- Any active autoimmune disease or documented history of autoimmune disease.
- Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), except for the following:
- History of any non-infectious hepatitis (eg, alcohol or non-alcoholic steatohepatitis, drug-related or auto-immune hepatitis).
- History of clinically significant cardiac disease.
- Uncontrolled current illness.
8. WOCBP and sexually active fertile men with WOCBP partners who are unwilling or unable to use acceptable contraception method to avoid pregnancy.
9. Women who are pregnant at Screening or prior to study drug administration. 10. Women who are breastfeeding. 11. History of significant immune-mediated AE . 13. Systemic use of the following therapies within 28 days prior to the first dose of study drug, or longer.
14. Subjects who got either below treatment:
- Any previous anti-CD137 mAb (eg, utomilumab, urelumab) treatment.
- Subject who has received allogenic hematopoietic stem cell transplant or autologous stem cell transplanted.
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：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 |
|---|---|
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実験的：ADG106 用量漸増
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IV infusion over 60 minutes on Day 1 of each cycle, at doses of 0.03 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg,10 mg/kg or 300mg flat dose depending on cohort at enrollment.
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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 |
時間枠 |
|---|---|
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Number of participants experiencing dose-limiting toxicities
時間枠：2 Cycles (42 days)
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2 Cycles (42 days)
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Number of participants experiencing clinical and laboratory adverse events (AEs)
時間枠：First dose to 28 days post last dose
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First dose to 28 days post last dose
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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The area under the curve (AUC) of plasma concentration of drug
時間枠：From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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Maximum concentration (Cmax)
時間枠：From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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Time at which maximum concentration (Tmax)
時間枠：From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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Lowest plasma concentration (C[trough])
時間枠：From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
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。
ADG106の臨床試験
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Adagene Inc完了
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National University Hospital, SingaporeMerck Sharp & Dohme LLC; Adagene Inc募集
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Adagene (Suzhou) Limited終了しました
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National University Hospital, SingaporeBristol-Myers Squibb; Adagene Inc; Singapore Translational Cancer Consortium募集
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National University Hospital, SingaporeAdagene Inc積極的、募集していない