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A Study of Gentuximab + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer

19. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

76

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • China
      • Shanghai, China
        • Shanghai First People's Hospital
      • Shanghai, China
        • Shanghai East Hospital
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Tumor Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • The Sixth Hospital of Sun Yat-sen University
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • The Affiliated Tumor Hospital of Harbin Medical University
    • Henan
      • Zhengzhou, Henan, China
        • the First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China
        • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
    • Jilin
      • Changchun, Jilin, China
        • The First Hospital of Jilin University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China
        • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Arzneimittel: Gentuximab
Administered intravenously (IV)
Arzneimittel: Paclitaxel
Intravenös verabreicht (iv)
Experimental: 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
Arzneimittel: Gentuximab
Administered intravenously (IV)
Arzneimittel: Paclitaxel
Intravenös verabreicht (iv)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Dose-limiting toxicities (DLT)
Zeitfenster: Up to 4 Weeks
Number of Participants With One or More Drug-Related Adverse Events (AEs) defined as DLT in the protocol
Up to 4 Weeks
AEs or SAEs
Zeitfenster: Baseline through Study Completion, about 24 weeks
Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)
Baseline through Study Completion, about 24 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Objective response rate（ORR）
Zeitfenster: Up to 6 cycles (28 days for every cycle)
Proportion of Participants With CR and PR
Up to 6 cycles (28 days for every cycle)
Progression-free survival (PFS)
Zeitfenster: Up to 6 cycles (28 days for every cycle)
The time from randomization to the patient tumor progression or death.
Up to 6 cycles (28 days for every cycle)
Disease control rate (DCR)
Zeitfenster: Up to 6 cycles (28 days for every cycle)
Proportion of Participants With CR, PR and SD
Up to 6 cycles (28 days for every cycle)
Time-to-progress (TTP)
Zeitfenster: Up to 6 cycles (28 days for every cycle)
The time from randomization to the patient tumor progression.
Up to 6 cycles (28 days for every cycle)
Time-to-failure (TTF)
Zeitfenster: Up to 6 cycles (28 days for every cycle)
The time from randomization to the patient withdraw from the study.
Up to 6 cycles (28 days for every cycle)
Anti-drug antibody
Zeitfenster: Up to 6 cycles (28 days for every cycle)
Number of Participants With Anti-drug Antibodies
Up to 6 cycles (28 days for every cycle)
Pharmacokinetics Cmax
Zeitfenster: Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle)
Maximum Concentration (Cmax)
Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle)
Area Under the Concentration-Time Curve (AUC)
Zeitfenster: 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）
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）

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Mitarbeiter

The First Affiliated Hospital with Nanjing Medical University
Fujian Cancer Hospital
Tongji Hospital
The First Affiliated Hospital of Zhengzhou University
The First Hospital of Jilin University
Sixth Affiliated Hospital, Sun Yat-sen University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai East Hospital
Zhejiang University
Sir Run Run Shaw Hospital
The Second Affiliated Hospital of Harbin Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. November 2019

Primärer Abschluss (Tatsächlich)

1. Juni 2020

Studienabschluss (Tatsächlich)

20. September 2020

Studienanmeldedaten

Zuerst eingereicht

27. Juli 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. August 2019

Zuerst gepostet (Tatsächlich)

12. August 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GenSci 043 CT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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