A Study of Gentuximab + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer
2026年5月19日 更新者：Changchun GeneScience Pharmaceutical Co., Ltd.
An Multi-center, Open-label Phase Ib/II Study of Gentuximab Injection + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer to Evaluate Tolerability, Safety, Efficacy and Pharmacokinetics.
The objective of the study is to evaluate Tolerability, Safety, and primary Efficacy of Gentuximab Injection at different dosage in combination with Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer patients, to ensure adequate treatment dosage for further study.
Meanwhile, the study also evaluate Pharmacokinetics of Gentuximab Injection at different dosage in combination with Paclitaxel.
調査の概要
詳細な説明
The study includes dose-limiting toxicity （DLT）observing period and randomization period with two cohorts as low-dose group（Gentuximab Injection 8mg/kg+ paclitaxel） and high-dose group（Gentuximab Injection 12mg/kg+ paclitaxel）.
During the study，the anti-cancer efficacy, safety and anti-drug antibody were evaluated in all patients.
DLT observation is only to subjects enrolled in DLT observation period and it lasts one treatment period.
PK were doing in part of subjects.
研究の種類
介入
入学 (実際)
76
段階
- フェーズ2
- 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。
研究場所
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Shanghai、中国
- Shanghai First People's Hospital
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Shanghai、中国
- Shanghai East Hospital
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Fujian
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Fuzhou、Fujian、中国
- Fujian Tumor Hospital
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Guangdong
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Guangzhou、Guangdong、中国
- The Sixth Hospital of Sun Yat-sen University
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Heilongjiang
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Harbin、Heilongjiang、中国
- The Affiliated Tumor Hospital of Harbin Medical University
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Henan
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Zhengzhou、Henan、中国
- The first affiliated hospital of Zhengzhou university
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Hubei
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Wuhan、Hubei、中国
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Jiangsu
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Nanjing、Jiangsu、中国
- Jiangsu Province Hospital
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Jilin
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Changchun、Jilin、中国
- The First Hospital of Jilin University
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Zhejiang
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Hangzhou、Zhejiang、中国
- The first Affiliated Hospital, Zhejiang University School of Medicine
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Hangzhou、Zhejiang、中国
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Hangzhou、Zhejiang、中国
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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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
18年～75年 (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:
- The subject can understand the process and methods of the study, complete the study in accordance with the protocol and is willing to sign a written informed consent.
- Male or female. aged between 18 and 75 years
- Histopathologically confirmed advanced advanced gastric or gastroesophageal junction cancer, and Documented progression during first-line fluoropyrimidine- and platinum- containing chemotherapy, or during the 3 months following the last cycle of such chemotherapy (or during the 6 months following the last dose of adjuvant therapy or new adjuvant therapy containing fluoropyrimidine and platinium).
- At least one Measurable lesion.
- ECOG Performance status (PS) score, 0-1 level.
- A life expectancy of >3 months.
- Adequate hematologic function, as defined by: Absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin concentration ≥90g/L (allowing blood transfusion); and platelet count ≥80×109/L.
- Adequate hepatic function, as defined by: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (liver metastases patients ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN).
- Adequate renal function, as defined by: serum creatinine level≤ 1.5 × ULN, or creatinine clearance ≥ 50ml / min when serum creatinine level> 1.5 × ULN.
- Adequate coagulation function, as defined by: International normalized ratio (INR) ≤1.5× ULN, activated partial thromboplastin time (aPTT) ≤1.5 x ULN.
- 24-hour urine protein quantitation is <1g（24-hour urine protein quantitative test should be performed when urine protein ≥1+ is found during screening visit）.
- Subjects (male and female) who have fertility must agree to use reliable contraceptive methods during the trial and in 3 months after the last administration. Female subjects in childbearing age must be negative for blood pregnancy test prior to enrollment.
Exclusion Criteria:
- Previously administrated with anti-angiogenic drugs or paclitaxel.
- Systematic anti-tumor therapy (non-anti-angiogenic drugs or paclitaxel) such as chemotherapy, radiotherapy, macromolecular targeted therapy, immunotherapy, endocrine therapy, etc. within 4 weeks before the first dose of investigational drug, except for the following: nitrourea or mitomycin C is within 6 weeks before the first dose, oral fluorouracil and small molecule targeted drugs are within 2 weeks or 5 half-life of the drug(whichever is longer) before the first dose，Chinese medicine with anti-cancer indications is within 2 weeks before the first dose.
- Has participated in a clinical study of a non-approved experimental agent within 4 weeks prior to screening visit.
- Has undergone major surgery within 4 weeks before screening visit (not including needle biopsy)， or would undergo planned surgery during the study.
- Subject with positive HCV-Ab, Anti-HIV or TP-Ab, or positive HBS-Ag with copies of HBV DNA > ULN.
- Patients with previously confirmed malignant tumors.
- History of arterial thrombosis or deep vein thrombosis within 6 months prior to screening, or a bleeding event no less than Grade level 3 within 2 months prior to screening， or the investigator determines that there is a risk of bleeding.
- History of severe cardiovascular and cerebrovascular diseases.
- Subjects with confirmed brain tumor metastases，but subjects in steady situation can be enrolled.
- Active bleeding confirmed by gastroscopy when fecal occult blood positive (only subjects with primary lesions not removed need to do fecal occult blood test.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 12 months before screening visit.
- Thoracic，abdominal or pericardial effusion that cannot be controlled by repeated drainage or with obvious symptoms.
- Has a nonhealing wound, serious ulcer, or unrecovered bone fracture.
- Active infections requiring systemic treatment, including but not limited to active tuberculosis.
- Using anticoagulation and antiplatelet drugs.
- Female subjects who is pregnant (confirmed by urine or serum pregnancy test) or lactating.
- Has a known serious allergy reaction to recombination monoclonal antibody (MAb) drug, ,or infusion reaction.
- Has known alcohol or drug dependency.
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：ランダム化
- 介入モデル：並列代入
- 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：1 Gentuximab+ Paclitaxel
8 mg/kg Gentuximab administered intravenously (IV) on D1 and D15（28 days every cycle）+ 80 mg/m² paclitaxel administered IV on D1, D8 and D15
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Administered intravenously (IV)
静脈内投与（iv）
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実験的：2 Gentuximab+ Paclitaxel
12 mg/kg Gentuximab administered intravenously (IV) on D1 and D15（28 days every cycle）+ 80 mg/m² paclitaxel administered IV on D1, D8 and D15
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Administered intravenously (IV)
静脈内投与（iv）
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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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Dose-limiting toxicities (DLT)
時間枠：Up to 4 Weeks
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Number of Participants With One or More Drug-Related Adverse Events (AEs) defined as DLT in the protocol
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Up to 4 Weeks
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AEs or SAEs
時間枠：Baseline through Study Completion, about 24 weeks
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Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)
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Baseline through Study Completion, about 24 weeks
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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 |
|---|---|---|
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Objective response rate（ORR）
時間枠：Up to 6 cycles (28 days for every cycle)
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Proportion of Participants With CR and PR
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Up to 6 cycles (28 days for every cycle)
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Progression-free survival (PFS)
時間枠：Up to 6 cycles (28 days for every cycle)
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The time from randomization to the patient tumor progression or death.
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Up to 6 cycles (28 days for every cycle)
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Disease control rate (DCR)
時間枠：Up to 6 cycles (28 days for every cycle)
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Proportion of Participants With CR, PR and SD
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Up to 6 cycles (28 days for every cycle)
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Time-to-progress (TTP)
時間枠：Up to 6 cycles (28 days for every cycle)
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The time from randomization to the patient tumor progression.
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Up to 6 cycles (28 days for every cycle)
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Time-to-failure (TTF)
時間枠：Up to 6 cycles (28 days for every cycle)
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The time from randomization to the patient withdraw from the study.
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Up to 6 cycles (28 days for every cycle)
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Anti-drug antibody
時間枠：Up to 6 cycles (28 days for every cycle)
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Number of Participants With Anti-drug Antibodies
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Up to 6 cycles (28 days for every cycle)
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Pharmacokinetics Cmax
時間枠：Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle)
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Maximum Concentration (Cmax)
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Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle)
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Area Under the Concentration-Time Curve (AUC)
時間枠：Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) （28 days for every cycle）
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Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) （28 days for every cycle）
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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。
協力者
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)
2019年11月5日
一次修了 (実際)
2020年6月1日
研究の完了 (実際)
2020年9月20日
試験登録日
最初に提出
2019年7月27日
QC基準を満たした最初の提出物
2019年8月9日
最初の投稿 (実際)
2019年8月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月22日
QC基準を満たした最後の更新が送信されました
2026年5月19日
最終確認日
2026年5月1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。