A Phase I Trial of GW01-200 Tablets in Subjects With Advanced Tumors (GW01-200-01)
2026年8月12日 更新者：Groovy Medicine (Hangzhou) Ltd.
A First-in-Human Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GW01-200 Tablets in Subjects With Advanced Tumors
A phase 1, open-label, first-in-human study mainly aimed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GW01-200 tablets in participants with advanced tumors, including solid tumors and hematological malignancies.
調査の概要
研究の種類
介入
入学 (推定)
100
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Yongchao Li
- 電話番号：86-13336882732
- メール：liyongchao@groovymedicine.com
研究場所
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100142
- 募集
- Peking University Cancer Hospital
-
コンタクト：
- Zhi-Hao Lu, M.D.
- 電話番号：86-13810549767
- メール：13810549767@126.com
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主任研究者：
- Zhi-Hao Lu, M.D.
-
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Heibei
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Langfang、Heibei、中国、065000
- 募集
- Hebei Cancer Hospital of Chinese Academy of Medical Sciences
-
コンタクト：
- Yong-Kun Sun, M.D.
- 電話番号：86-131 4127 6041
- メール：hsunyk@cicams.ac.cn
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Zhejiang
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Hangzhou、Zhejiang、中国、310022
- 募集
- Zhejiang Cancer Hospital
-
コンタクト：
- Zheng-Bo Song, M.D.
- 電話番号：86-13857153345
- メール：songzb@zjcc.org.cn
-
主任研究者：
- Zheng-Bo Song, M.D.
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Documented locally advanced or metastatic solid tumors or advanced hematological malignancies, with disease progression after standard treatment, or intolerant to standard treatment, or no standard treatment is available.
- Have at least one measurable target lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Minimum life expectancy ≥ 3 months.
- Adequate organ and marrow function.
Exclusion Criteria:
- Participants with a known hypersensitivity to the investigational product(s) or any of the excipients of the product(s).
- History of other primary malignancies, except for those who have been curatively treated and have no known active disease within 5 years prior to the first dose with a very low potential for recurrence, or adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid cancer with no evidence of disease.
- Presence of primary central nervous system (CNS) tumors or symptomatic brain metastases; prior or current leptomeningeal disease or spinal cord compression.
- Radiographic evidence of tumor invasion into major blood vessels (tumor completely approaching, surrounding, or invading the lumen of major blood vessels such as the pulmonary artery or superior vena cava) or evidence of tumor thrombus.
- Received systemic anti-tumor therapy within 28 days prior to the first dose, including chemotherapy, targeted therapy, anti-angiogenic drugs, biological therapy, immunotherapy, radiotherapy, etc., or received traditional Chinese medicine or herbal medicines with clear anti-tumor effects within 1 week prior to the first dose.
- Treatment with medications that may affect the metabolism of the investigational drug within 14 days prior to the first dose, such as strong CYP3A inhibitors, strong CYP3A inducers, or P-gp inhibitors.
- Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of the investigational drug.
- Known to have active infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis.
- Known history of infection with human immunodeficiency virus (HIV).
- Active gastrointestinal disease or other condition that will interfere significantly with the swallowing, absorption, distribution, metabolism, or excretion of oral therapy.
- For female subjects: currently pregnant or lactating.
- Presence of clinically significant severe ophthalmic examination abnormalities at screening, such as retinitis pigmentosa, maculopathy, active ocular infection, etc., or known history of retinal or optic nerve disorders, such as retinitis pigmentosa, maculopathy, glaucoma, optic neuritis, etc.
- Participants with a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or a history of melena or hematemesis within 2 months before dosing, or those who may experience visceral hemorrhage as determined by the investigator.
- Clinically symptomatic moderate to severe ascites or pleural effusion, or presence of uncontrolled or moderate to severe pericardial effusion.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：非ランダム化
- 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：Ia-Part A
Participants with advanced solid tumors will receive GW01-200 tablets orally at ascending dose levels.
|
GW01-200 tablets will be administered orally.
|
|
実験的：Ia-Part B
Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets orally at ascending dose levels.
|
GW01-200 tablets will be administered orally.
|
|
実験的：Ib-Part C
Participants with advanced solid tumors will receive GW01-200 tablets at the specified dose.
|
GW01-200 tablets will be administered orally.
|
|
実験的：Ib-Part D
Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets at the specified dose.
|
GW01-200 tablets will be administered orally.
|
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 |
|---|---|---|
|
Number of participants with adverse events (AEs) and serious AEs (SAEs)
時間枠：Up to approximately 2 years
|
To assess the safety and tolerability of GW01-200 tablets.
|
Up to approximately 2 years
|
|
Parts A and B: The recommended dose(s) for expansion (RDEs) of GW01-200 tablets
時間枠：At the end of Cycle 1 (each cycle is 28 days)
|
Number of participants with dose-limiting toxicities (DLTs)
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At the end of Cycle 1 (each cycle is 28 days)
|
|
Parts C and D: The preliminary efficacy of GW01-200 tablets at the RDEs dose.
時間枠：Up to approximately 2 years
|
Objective response rate (ORR) assessed by investigator.
|
Up to approximately 2 years
|
|
Parts C and D: The recommended Phase II Dose (RP2D) of GW01-200 tablets
時間枠：Up to approximately 2 years
|
The RP2D of GW01-200 tablets will be determined based on the data obtained from Parts C and D.
|
Up to approximately 2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum concentration (Cmax)
時間枠：Up to approximately 2 years
|
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
|
Up to approximately 2 years
|
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Area under the concentration-time curve (AUC)
時間枠：Up to approximately 2 years
|
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
|
Up to approximately 2 years
|
|
Time to maximum concentration (Tmax)
時間枠：Up to approximately 2 years
|
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
|
Up to approximately 2 years
|
|
Elimination half-life (t1/2)
時間枠：Up to approximately 2 years
|
To characterise the pharmacokinetics (PK) of GW01-200 when given orally
|
Up to approximately 2 years
|
|
Parts A and B: The preliminary efficacy of GW01-200 tablets in participants with advanced tumors
時間枠：Up to approximately 2 years
|
ORR assessed by investigator.
|
Up to approximately 2 years
|
|
Duration of response (DoR)
時間枠：Up to approximately 2 years
|
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
|
Up to approximately 2 years
|
|
Disease control rate (DCR)
時間枠：Up to approximately 2 years
|
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
|
Up to approximately 2 years
|
|
Progression-free survival (PFS)
時間枠：Up to approximately 2 years
|
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
|
Up to approximately 2 years
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月17日
一次修了 (推定)
2029年1月1日
研究の完了 (推定)
2029年6月1日
試験登録日
最初に提出
2026年5月27日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月14日
QC基準を満たした最後の更新が送信されました
2026年8月12日
最終確認日
2026年8月1日
詳しくは
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