- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04164615
Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection
A Randomized, Double-blind, Multi-center Phase Ⅲ Clinical Study to Evaluate the Recombinant Anti-HER2 Humanized Monoclonal Antibody or Placebo in Combination With Capecitabine for the Treatment of HER-2-positive Advanced Breast Cancer
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine, 100071
- Recrutement
- People's Liberation Army General Hospital The Fifth Medical Center
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Chercheur principal:
- Ze Fei Jiang, Ph.D
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria
- Aged 18 to 70 years;
Pathologically confirmed as advanced breast cancer and there is at least one measurable target lesion (based on RECIST V1.1):
l According to Response Evaluation Criteria in Solid Tumors, the target lesions must be accurately measured in at least one dimension; l No previous radiotherapy, intervention for target lesions;
- HER-2 positive [definition: including IHC (+++) or ISH positive; if IHC (++), HER-2 gene amplification detection should be further performed through fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH),silver-enhanced in situ hybridization (SISH) and other methods. The test reports of the clinical study site associated with the subject should be provided];
- The relapsed or metastatic patients who failed respond to the previous taxanes and/or anthracyclines, previous first-line chemotherapy for the metastatic lesion is acceptable;
- The expected survival is 3 months or longer;
- The function of major organs such as heart, liver and kidney are basically normal;
- ECOG score ≤2;
- Understand and voluntarily sign the written informed consent form;
2 Exclusion Criteria
- Pregnant or breastfeeding females; or women of childbearing potential who have positive serum/urine pregnancy tests; females of childbearing potential and their partners are unwilling to adopt effective contraceptive methods during the clinical study period and within 6 months after the end of the study;
- Received radiotherapy or chemotherapy within 4 weeks before randomization;
- Received anti-tumor endocrine therapy within 2 weeks before randomization;
- Previously received the standard anti-HER-2 treatment;
- Previously received capecitabine treatment;
- Subjects who previously received no taxanes; or subjects who respond to taxanes (no disease progression or intolerable toxic reactions);
- The major organ function of subjects is abnormal. The laboratory test results are presented below:
Hematology test:
l Absolute neutrophil count (ANC) < 1.5×109/L; l Platelet count (PLT) <100×109/L; l Hemoglobin (Hb) < 90 g/L (no blood transfusion within 14 days);
Hepatic and renal function tests:
l Bilirubin (TBIL)>1.5×ULN (upper limit of normal); l Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)>2.5×ULN; if there is any hepatic metastasis, ALT and AST >5×ULN; l Serum creatinine (Cr) >1.5×ULN; 8. Left ventricular ejection fraction ( LVEF)<50%; 9. The organ system status of subjects:
1 Subjects with known or suspected brain metastasis: subjects with evidence indicating signs or symptoms of brain metastasis are not allowed to participate in this study unless such brain metastasis is excluded by CT or MRI. However, subjects whose brain metastasis lesions have been controlled can be enrolled (no progression within at least 4 weeks after radiotherapy and/or no neurological symptom or sign after surgical resection, treatment with dexamethasone or mannitol is not necessary);
1 Evidence showing severe or uncontrolled systemic diseases (e.g. unstable or non-compensated respiratory, cardiac, hepatic or renal disease);
1 Uncontrolled active infection (≥CTCAE grade 2); l Any other malignant tumor within 5 years, excluding patients with completely cured cervical in situ carcinoma or basal cell or squamous epithelial cell skin cancer);
1 Subjects who have any of the following cardiac conditions:
- Unstable angina pectoris;
- Medical history of congestive heart failure;
- Previous medical history of myocardial infarction, coronary artery bypass grafting or coronary stent implantation;
- Clinically significant pericardial diseases and valvular heart diseases;
- Cardiac arrhythmias requiring therapeutic intervention;
- Any other cardiac diseases which may cause safety risks for subjects if they are enrolled in this study; 1 Uncontrolled hypertension (defined as screening systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥110mmHg); 10. Immunodeficiency medical history, including positive HIV detection; 11. Positive hepatitis B surface antigen (HBsAg) and hepatitis B virus DNA of peripheral blood is not within the normal range; Positive hepatitis C virus antibody (HCV); 12. Subjects with drug abuse history or alcohol addiction history; 13. Participated in clinical study with drug intervention within one month before screening; 14. Subjects who are unsuitable for participation in this study at the discretion of the investigators.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: GB221+ Capecitabine tablets
test drug+capecitabine
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GB221:Lyophilized powder for injection; strength 110mg/bottle; the first administration of 8 mg/kg, intravenous drip for over 90 minutes; subsequently, the administration shall be given once every 3 weeks (one cycle), the dose is 6 mg/kg, intravenous drip for 30~90 minutes; The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study. Capecitabine:Tablets; 500mg/tablet, 12 tablets/box; Total daily dose 2000 mg/m2, orally twice daily, one dose each in the morning and evening, administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle. The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study.
Autres noms:
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Comparateur placebo: Placebo control + capecitabine tablets
placebo+capecitabine
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Placebo control:Lyophilized powder for injection; strength 110mg/bottle; the first administration of 8 mg/kg, intravenous drip for over 90 minutes; subsequently, the administration shall be given once every 3 weeks (one cycle), the dose is 6 mg/kg, intravenous drip for 30~90 minutes; The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study. Capecitabine:Tablets; 500mg/tablet, 12 tablets/box; Total daily dose 2000 mg/m2, orally twice daily, one dose each in the morning and evening, administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle. The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Progression-free survival, PFS
Délai: through study completion, an average of 2 year
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To evaluate the efficacy of GB221 as defined by progression-free survival in patients with breast cancer.
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through study completion, an average of 2 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Objective Response Rate, ORR
Délai: through study completion, an average of 2 year
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To evaluate the efficacy of GB221 as defined by overall response rate, in patients with breast cancer.
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through study completion, an average of 2 year
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Antidrug antibody, ADA
Délai: through study completion, an average of 2 year
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Antidrug antibody, ADA
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through study completion, an average of 2 year
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Overall survival, OS
Délai: through study completion, an average of 2 year
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To evaluate the duration from the first administration to death because of any reason in patients with breast cancer.
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through study completion, an average of 2 year
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PFS in the extended treatment phase
Délai: through study completion, an average of 2 year
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PFS in the extended treatment phase
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through study completion, an average of 2 year
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GENOR GB221-003;V1.1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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Essais cliniques sur HER-2-positive Advanced Breast Cancer
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Washington University School of MedicineMolecular Templates, Inc.RetiréTumeur solide HER2 positive | Cancer HER-2 positif
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Orum Therapeutics USA, Inc.RecrutementCancer du sein HER2 positif | Amplification du gène HER-2 | Mutation du gène HER2 | Surexpression de la protéine HER-2États-Unis
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Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH)RecrutementCancer du sein métastatique HER2 positif | Surexpression de la protéine HER-2 | Carcinome malin du sein HER-2 positifÉtats-Unis
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Bellicum PharmaceuticalsSuspenduCancer du sein HER2 positif | Cancer gastrique HER2 positif | Tumeur solide, adulte | Amplification du gène HER-2 | Surexpression de la protéine HER-2États-Unis
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H. Lee Moffitt Cancer Center and Research InstituteRésiliéCancer du sein | Cancer du sein, homme | Cancer du sein HER2 positif | Amplification du gène HER-2 | Cancer du sein féminin | Carcinome du sein HER2 positif | Surexpression de la protéine HER-2États-Unis
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Alliance Foundation Trials, LLC.Pfizer; Syneos Health; UNICANCER; German Breast Group; SOLTI Breast Cancer Research... et autres collaborateursActif, ne recrute pasCancer du sein HER-2 positif | Cancer du sein positif aux récepteurs des œstrogènesÉtats-Unis, Espagne, France, Italie, Allemagne, Australie, Le Portugal, Nouvelle-Zélande
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Eli Lilly and CompanyComplétéCancer du sein HER-2 positif | Cancer du sein positif aux récepteurs hormonauxEspagne, États-Unis, Corée, République de, Belgique, France, Allemagne, Italie, Australie, Argentine, Canada, Royaume-Uni, Mexique, Brésil, Grèce
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Zhimin ShaoRoche Pharma AGInconnueCancer du sein HER-2 positifChine
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Hospices Civils de LyonPas encore de recrutement
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Texas Tech University Health Sciences Center, El...RetiréCancer du sein | Cancer du sein métastatique | Cancer du sein HER-2 positif | Cancer du sein ER positif
Essais cliniques sur GB221
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Genor Biopharma Co., Ltd.Complété
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Genor Biopharma Co., Ltd.ComplétéCancer du sein métastatiqueAustralie
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Genor Biopharma Co., Ltd.RecrutementCancer du sein HER2 positifChine
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Veana TherapeuticsUniversity of WashingtonRecrutementCancer du sein anatomique de stade IV AJCC v8 | Carcinome du sein HER2 positif | Carcinome du sein métastatique | Carcinome du sein réfractaireÉtats-Unis